127. 前頭側頭葉変性症
［臨床試験数：74，薬物数：83（DrugBank：28），標的遺伝子数：29，標的パスウェイ数：99］
Searched query = "Frontotemporal lobar degeneration", "Frontotemporal dementia", "Semantic dementia"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2019-004066-18-GB (EUCTR) | 03/12/2020 | 25/09/2020 | A Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of AL001 in FTD | A Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk for or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene | Frontotemporal Dementia MedDRA version: 21.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AL001 Product Code: AL001 INN or Proposed INN: not available Other descriptive name: AL001 | Alector Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | Portugal;United States;Spain;United Kingdom;Italy;Switzerland;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 2 | EUCTR2019-004066-18-SE (EUCTR) | 06/10/2020 | 10/06/2020 | A Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of AL001 in FTD | A Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk for or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene | Frontotemporal Dementia MedDRA version: 21.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AL001 Product Code: AL001 INN or Proposed INN: not available Other descriptive name: AL001 | Alector Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | Portugal;United States;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 3 | EUCTR2019-004066-18-NL (EUCTR) | 02/09/2020 | 03/03/2020 | A Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of AL001 in FTD | A Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk for or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene | Frontotemporal Dementia MedDRA version: 21.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AL001 Product Code: AL001 INN or Proposed INN: not available Other descriptive name: AL001 | Alector Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | United States;Portugal;France;Canada;Spain;Belgium;Australia;Germany;Netherlands;United Kingdom;Italy;Sweden | ||
| 4 | EUCTR2019-004066-18-BE (EUCTR) | 31/07/2020 | 26/05/2020 | A Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of AL001 in FTD | A Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk for or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene | Frontotemporal Dementia MedDRA version: 21.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AL001 Product Code: AL001 INN or Proposed INN: not available Other descriptive name: AL001 | Alector Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | United States;Portugal;France;Canada;Spain;Belgium;Australia;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 5 | NCT04408625 (ClinicalTrials.gov) | July 30, 2020 | 21/5/2020 | Phase 1/2 Clinical Trial of PR006 in Patients With Frontotemporal Dementia With Progranulin Mutations (FTD-GRN) | A Phase 1/2 Ascending Dose Study to Evaluate the Safety and Effects on Progranulin Levels of PR006A in Patients With Fronto-Temporal Dementia With Progranulin Mutations (FTD-GRN) | Frontotemporal Dementia | Biological: PR006;Drug: Methylprednisolone;Drug: Sirolimus;Drug: Prednisone | Prevail Therapeutics | NULL | Recruiting | 30 Years | 80 Years | All | 15 | Phase 1;Phase 2 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | NCT04374136 (ClinicalTrials.gov) | July 23, 2020 | 23/4/2020 | A Phase 3 Study to Evaluate Efficacy and Safety of AL001 in Frontotemporal Dementia (INFRONT-3) | A Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk for or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene | Frontotemporal Dementia | Drug: AL001;Drug: Placebo | Alector Inc. | NULL | Recruiting | 18 Years | 85 Years | All | 180 | Phase 3 | United States;Australia;Belgium;Canada;France;Germany;Italy;Netherlands;Portugal;Spain;Sweden;Switzerland;United Kingdom |
| 7 | EUCTR2019-004066-18-DE (EUCTR) | 06/07/2020 | 20/02/2020 | A Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of AL001 in FTD | A Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk for or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene | Frontotemporal Dementia MedDRA version: 21.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AL001 Product Code: AL001 INN or Proposed INN: not available Other descriptive name: AL001 | Alector Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | Portugal;United States;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 8 | EUCTR2019-004066-18-PT (EUCTR) | 29/05/2020 | 21/02/2020 | A Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of AL001 in FTD | A Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk for or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene | Frontotemporal Dementia MedDRA version: 21.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AL001 Product Code: AL001 INN or Proposed INN: not available Other descriptive name: AL001 | Alector Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | Portugal;United States;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 9 | EUCTR2019-004066-18-ES (EUCTR) | 22/04/2020 | 06/03/2020 | A Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of AL001 in FTD | A Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk for or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene | Frontotemporal Dementia MedDRA version: 21.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AL001 Product Code: AL001 INN or Proposed INN: not available Other descriptive name: AL001 | Alector Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | United States;Portugal;France;Canada;Belgium;Spain;Australia;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 10 | NCT04220021 (ClinicalTrials.gov) | January 10, 2020 | 3/1/2020 | Safety and Therapeutic Potential of the FDA-approved Drug Metformin for C9orf72 ALS/FTD | A Single-Center, Open Label Study to Assess the Safety and Tolerability of Metformin in Subjects With C9orf72 Amyotrophic Lateral Sclerosis Over 24 Weeks of Treatment | C9orf72 Amyotrophic Lateral Sclerosis (ALS);Frontotemporal Dementia | Drug: Metformin | University of Florida | NULL | Recruiting | 18 Years | 80 Years | All | 18 | Phase 2 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | EUCTR2019-000138-20-GB (EUCTR) | 18/11/2019 | 21/05/2019 | An Open-Label Study to Evaluate Safety of long-term AL001 dosing in FTD | A Phase 2, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AL001 in Heterozygous Carriers of Granulin or C9ORF72 Mutations Causative of Frontotemporal Dementia | Frontotemporal Dementia MedDRA version: 21.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AL001 Product Code: AL001 INN or Proposed INN: not available Other descriptive name: AL001 | Alector Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 32 | Phase 2 | United States;Canada;Netherlands;Germany;Italy;United Kingdom | ||
| 12 | EUCTR2019-000138-20-DE (EUCTR) | 08/10/2019 | 27/05/2019 | An Open-Label Study to Evaluate Safety of long-term AL001 dosing in FTD | A Phase 2, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AL001 in Heterozygous Carriers of Granulin or C9ORF72 Mutations Causative of Frontotemporal Dementia | Frontotemporal Dementia MedDRA version: 21.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AL001 Product Code: AL001 INN or Proposed INN: not available Other descriptive name: AL001 | Alector Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | United States;Canada;Netherlands;Germany;United Kingdom;Italy | ||
| 13 | NCT03987295 (ClinicalTrials.gov) | September 27, 2019 | 14/5/2019 | A Phase 2 Study to Evaluate Safety of Long-term AL001 Dosing in Frontotemporal Dementia (FTD) Patients (INFRONT-2) | A Phase 2, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AL001 in Heterozygous Carriers of Granulin or C9orf72 Mutations Causative of Frontotemporal Dementia | Frontotemporal Dementia | Drug: AL001 | Alector Inc. | NULL | Recruiting | 18 Years | 85 Years | All | 40 | Phase 2 | United States;Canada;Germany;Italy;Netherlands;United Kingdom |
| 14 | EUCTR2019-000138-20-NL (EUCTR) | 20/09/2019 | 06/06/2019 | An Open-Label Study to Evaluate Safety of long-term AL001 dosing in FTD | A Phase 2, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AL001 in Heterozygous Carriers of Granulin or C9ORF72 Mutations Causative of Frontotemporal Dementia | Frontotemporal Dementia MedDRA version: 21.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AL001 Product Code: AL001 INN or Proposed INN: not available Other descriptive name: AL001 | Alector Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | United States;Canada;Germany;Netherlands;United Kingdom;Italy | ||
| 15 | NCT04115384 (ClinicalTrials.gov) | September 9, 2019 | 2/10/2019 | Intranasal Insulin in Frontotemporal Dementia (FTD) | A Single Center Feasibility Study of Intranasal Insulin in Frontotemporal Dementia NIFT-D | Frontotemporal Dementia, Behavioral Variant | Drug: Novolin-R insulin | HealthPartners Institute | NULL | Recruiting | 41 Years | 89 Years | All | 12 | Phase 2 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | NCT04489017 (ClinicalTrials.gov) | June 1, 2019 | 13/4/2020 | Palmitoylethanolamide Combined With Luteoline in Frontotemporal Dementia Patients. A Randomized Controlled Trial | Palmitoylethanolamide Combined With Luteoline in Frontotemporal Dementia Patients. A Randomized Controlled Trial | Frontotemporal Dementia | Dietary Supplement: PEA-LUT;Dietary Supplement: PLACEBO | I.R.C.C.S. Fondazione Santa Lucia | NULL | Recruiting | 40 Years | 80 Years | All | 50 | N/A | Italy |
| 17 | NCT03636204 (ClinicalTrials.gov) | September 14, 2018 | 12/7/2018 | A First in Human Study in Healthy Volunteers and in Participants With Frontotemporal Dementia With Granulin (GRN) Mutation | A First in Human Phase 1 Study in Healthy Volunteers and in Participants With Frontotemporal Dementia (FTD) With Granulin Mutation | Healthy;Frontotemporal Dementia | Biological: AL001;Other: Placebo | Alector Inc. | NULL | Completed | 18 Years | 80 Years | All | 64 | Phase 1 | United States;Canada;United Kingdom;Netherlands |
| 18 | NCT03658135 (ClinicalTrials.gov) | September 12, 2018 | 13/8/2018 | BIIB092 in Primary Tauopathies: CBS, nfvPPA, sMAPT, and TES | A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Parallel Cohort Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy Study of Intravenously Infused BIIB092 in Patients With Four Different Primary Tauopathy Syndromes | Primary Tauopathies;Corticobasal Degeneration Syndrome;Frontotemporal Lobar Degeneration With Tau Inclusions;MAPT Mutation Carriers, Symptomatic;Traumatic Encephalopathy Syndrome;Nonfluent Aphasia, Progressive | Drug: BIIB092;Other: Placebo | University of California, San Francisco | NULL | Terminated | 35 Years | 80 Years | All | 22 | Phase 1 | United States |
| 19 | NCT03510572 (ClinicalTrials.gov) | June 4, 2018 | 17/4/2018 | Evaluation of [18F]PI-2620 as a Potential Positron Emission Computed Tomography Radioligand for Imaging Tau Protein in the Brain | Clinical Evaluation of [18F]PI-2620 Positron Emission Computed Tomography for Imaging Tau Protein in Patients With Tauopathies and Healthy Volunteers: Phase 0 Study | Healthy Volunteer;Alzheimer Disease;Frontotemporal Dementia;Parkinson Disease | Drug: [18F]PI-2620 | Asan Medical Center | Korea Health Industry Development Institute | Completed | 40 Years | 80 Years | All | 20 | Early Phase 1 | Korea, Republic of |
| 20 | NCT03260920 (ClinicalTrials.gov) | January 31, 2018 | 19/7/2017 | Intranasal Oxytocin for Frontotemporal Dementia | A Phase 2 Clinical Trial of Intranasal Oxytocin for Frontotemporal Dementia | Frontotemporal Dementia | Drug: Syntocinon | Lawson Health Research Institute | Weston Brain Institute;Canadian Institutes of Health Research (CIHR);Berry Consultants | Recruiting | 30 Years | 80 Years | All | 112 | Phase 2 | United States;Canada |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | NCT03625128 (ClinicalTrials.gov) | January 2, 2018 | 12/7/2018 | 18F-PM-PBB3 PET Study in Tauopathy Including Alzheimer's Disease, Other Dementias and Normal Controls | Phase 0 Evaluation of Clinical and Neuroimage (18F-PM-PBB3 PET) Study in Tauopathy Including Alzheimer's Disease, Other Dementias and Normal Controls | Alzheimer's Disease;Cortical Basal Syndrome;Frontotemporal Dementia;Progressive Supranuclear Palsy;Vascular Cognitive Impairment | Drug: F-18 | Chang Gung Memorial Hospital | NULL | Completed | 20 Years | 90 Years | All | 36 | Early Phase 1 | Taiwan |
| 22 | NCT02707978 (ClinicalTrials.gov) | September 30, 2017 | 7/4/2015 | F 18 T807 Tau PET Imaging of Frontotemporal Dementia (FTD) | F 18 T807 Tau PET Imaging of Frontotemporal Dementia | Alzheimer Disease | Drug: F 18 T807 | Tammie L. S. Benzinger, MD, PhD | NULL | Withdrawn | 18 Years | N/A | All | 0 | Phase 2 | United States |
| 23 | NCT03272230 (ClinicalTrials.gov) | September 6, 2017 | 3/8/2017 | Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System | Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System in Healthy Subject and Patient With Cerebral Disease | Apathy;Frontotemporal Dementia;Parkinson Disease;Depressive Symptoms | Behavioral: ECOCAPTURE;Behavioral: Cognitive and Behavioral experimental tasks;Diagnostic Test: Neuropsychological assessment;Behavioral: ICM_APATHY_TASKS;Other: MRI;Biological: Neurohormonal mechanisms;Diagnostic Test: Supplementary Neuropsychological Assessment - Parkinson's Disease | Institut National de la Santé Et de la Recherche Médicale, France | NULL | Recruiting | 40 Years | 85 Years | All | 135 | N/A | France |
| 24 | NCT03545126 (ClinicalTrials.gov) | August 21, 2017 | 12/3/2018 | Human CNS Tau Kinetics in Tauopathies | Human CNS Tau Kinetics in Tauopathies | Progressive Supranuclear Palsy (PSP);Corticobasal Degeneration (CBD);Frontotemporal Dementia (FTD MAPT Mutation) | Other: 13C6 Leucine | Washington University School of Medicine | Association of Frontotemporal Degeneration;Tau Consortium | Recruiting | 18 Years | N/A | All | 32 | United States | |
| 25 | NCT03174938 (ClinicalTrials.gov) | May 15, 2017 | 28/5/2017 | The Swedish BioFINDER 2 Study | The Swedish BioFINDER 2 Study | Dementia;Alzheimer Disease;Parkinson Disease;Lewy Body Disease;Parkinson-Dementia Syndrome;Frontotemporal Degeneration;Semantic Dementia;Progressive Nonfluent Aphasia;Progressive Supranuclear Palsy;Corticobasal Degeneration;Multiple System Atrophy;Mild Cognitive Impairment | Diagnostic Test: Flutemetamol F18 Injection;Diagnostic Test: [18F]-RO6958948;Diagnostic Test: Elecsys (Roche) Abeta42, Ttau and Ptau;Diagnostic Test: Lumipulse (Fujirebio) Abeta42, Ttau and Ptau | Skane University Hospital | Lund University | Recruiting | 20 Years | 100 Years | All | 1505 | N/A | Sweden |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 26 | NCT03040713 (ClinicalTrials.gov) | April 11, 2017 | 31/1/2017 | Flortaucipir PET Imaging in Subjects With FTD | 18F-AV-1451 PET Imaging in Subjects With Frontotemporal Dementia | Frontotemporal Dementia | Drug: Flortaucipir F18;Procedure: Brain PET scan | Avid Radiopharmaceuticals | NULL | Completed | 18 Years | N/A | All | 16 | Phase 1 | United States |
| 27 | EUCTR2017-000094-36-SE (EUCTR) | 31/03/2017 | 30/01/2017 | The BioFINDER 2 study - improved diagnostics and increased understanding of the underlying mechanisms of cognitive disorders | The BioFINDER 2 study - improved diagnostics and increased understanding of the pathophysiology of cognitive disorders | Neurodegenerative disorders with Tau-pathology; including, but not limited to, Alzheimers disease, progressive supranuclear palsy,frontotemporal dementia, corticobasal degeneration and mild cognitive impairment. MedDRA version: 19.1;Level: PT;Classification code 10053643;Term: Neurodegenerative disorder;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.1;Classification code 10012267;Term: Dementia;Classification code 10067889;Term: Dementia with Lewy bodies;Level: HLGT;Classification code 10028037;Term: Movement disorders (incl parkinsonism);Classification code 10012271;Term: Dementia Alzheimer's type;Level: HLT;Classification code 10001897;Term: Alzheimer's disease (incl subtypes);Level: LLT;Classification code 10009846;Term: Cognitive impairment;Classification code 10048598;Term: Cognitive disorders;Classification code 10001896;Term: Alzheimer's disease;Classification code 10012285;Term: Dementia due to Pick's disease;Classification code 10036813;Term: Progressive supranuclear palsy;Classification code 10074616;Term: Prodromal Alzheimer's;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] | Product Name: 18F-RO6958948 Trade Name: Vizamyl (flutemetamol(F-18)) Product Name: Vizamyl | Skåne University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 2 | Sweden | |||
| 28 | NCT02862210 (ClinicalTrials.gov) | January 27, 2017 | 7/8/2016 | Low-Dose Lithium for the Treatment of Behavioral Symptoms in Frontotemporal Dementia | Low-Dose Lithium for the Treatment of Behavioral Symptoms in Frontotemporal Dementia | Frontotemporal Dementia (FTD) | Drug: Lithium Carbonate;Drug: Placebo | Columbia University | Alzheimer's Drug Discovery Foundation | Recruiting | 40 Years | 85 Years | All | 60 | Phase 2 | United States |
| 29 | EUCTR2015-005604-29-NL (EUCTR) | 16/11/2016 | 20/01/2016 | Imaging of tau in patients with dementia | Tau-imaging in tauopathies; Alzheimer’s disease and non-AD dementias - TITAN | Dementia inducing Alzheimer's disease, Frontotemporal dementia (FTD) and Lewy Body Dementia (DLB) MedDRA version: 20.0;Level: PT;Classification code 10012271;Term: Dementia Alzheimer's type;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: LLT;Classification code 10057095;Term: Diffuse Lewy body disease;System Organ Class: 100000072901 MedDRA version: 20.0;Classification code 10068968;Term: Frontotemporal dementia;Classification code 10012283;Term: Dementia due to other general medical conditions;System Organ Class: 100000014717;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 18F-AV-1451 INN or Proposed INN: not applicable Other descriptive name: T807 | VU University Medical Center | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 2 | Netherlands | |||
| 30 | NCT02676843 (ClinicalTrials.gov) | April 2016 | 15/1/2016 | Tau PET Imaging With 18F-AV-1451 in Subjects With MAPT Mutations | Tau PET Imaging With 18F-AV-1451 in Subjects With MAPT Mutations | Frontotemporal Lobar Degeneration (FTLD);Frontotemporal Dementia (FTD);Tauopathies | Drug: 18F-AV-1451 | Columbia University | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | 18 Years | N/A | All | 7 | Phase 2 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 31 | EUCTR2014-002013-37-NL (EUCTR) | 24/03/2016 | 13/07/2015 | An open-label extension study evaluating the safety and tolerability of leuco-methylthioninium dihydromesylate (LMTM) in subjects with Alzheimer's Disease or a rare form of dementia (Behavioral Variant Frontotemporal Dementia) who have completed an earlier Phase trial | An Open-Label, Extension Study of the Effects of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Alzheimer’s Disease or Behavioral Variant Frontotemporal Dementia | Alzheimer’s Disease and behavioral variant Frontotemporal Dementia MedDRA version: 19.0;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0;Level: LLT;Classification code 10001896;Term: Alzheimer's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Leuco-methylthioninium bis(hydromethanesulfonate) Product Code: LMTM/TRx0237 INN or Proposed INN: N/A Other descriptive name: N,N,N',N'-tetramethyl-10H-phenothiazine-3,7-diaminium bis(methanesulfonate) | TauRx Therapeutics Ltd | NULL | Not Recruiting | Female: yes Male: yes | 966 | Phase 3 | United States;Taiwan;Finland;Spain;Russian Federation;United Kingdom;France;Canada;Malaysia;Belgium;Singapore;Romania;Croatia;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of | ||
| 32 | EUCTR2014-002013-37-BE (EUCTR) | 03/06/2015 | 31/03/2015 | An open-label extension study evaluating the safety and tolerability of leuco-methylthioninium dihydromesylate (LMTM) in subjects with Alzheimer's Disease or a rare form of dementia (Behavioral Variant Frontotemporal Dementia) who have completed an earlier Phase trial | An Open-Label, Extension Study of the Effects of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Alzheimer’s Disease or Behavioral Variant Frontotemporal Dementia | Alzheimer’s Disease and behavioral variant Frontotemporal Dementia MedDRA version: 18.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.1;Level: LLT;Classification code 10001896;Term: Alzheimer's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Leuco-methylthioninium bis(hydromethanesulfonate) Product Code: LMTM/TRx0237 INN or Proposed INN: N/A Other descriptive name: N,N,N',N'-tetramethyl-10H-phenothiazine-3,7-diaminium bis(methanesulfonate) | TauRx Therapeutics Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Phase 3 | United States;Taiwan;Finland;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Malaysia;Belgium;Singapore;Romania;Croatia;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of | ||
| 33 | EUCTR2014-002013-37-FI (EUCTR) | 11/05/2015 | 25/03/2015 | An open-label extension study evaluating the safety and tolerability of leuco-methylthioninium dihydromesylate (LMTM) in subjects with Alzheimer's Disease or a rare form of dementia (Behavioral Variant Frontotemporal Dementia) who have completed an earlier Phase trial | An Open-Label, Extension Study of the Effects of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Alzheimer’s Disease or Behavioral Variant Frontotemporal Dementia | Alzheimer’s Disease and behavioral variant Frontotemporal Dementia MedDRA version: 19.0;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0;Level: LLT;Classification code 10001896;Term: Alzheimer's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Leuco-methylthioninium bis(hydromethanesulfonate) Product Code: LMTM/TRx0237 INN or Proposed INN: N/A Other descriptive name: N,N,N',N'-tetramethyl-10H-phenothiazine-3,7-diaminium bis(methanesulfonate) | TauRx Therapeutics Ltd | NULL | Not Recruiting | Female: yes Male: yes | 966 | Phase 3 | United States;Taiwan;Finland;Spain;Russian Federation;United Kingdom;France;Canada;Belgium;Malaysia;Singapore;Romania;Croatia;Australia;Netherlands;Germany;Korea, Republic of | ||
| 34 | EUCTR2014-001489-85-BE (EUCTR) | 05/03/2015 | 24/10/2014 | A study to investigate 2 doses of investigational drug on patients with Prodromal to Moderate Frontotemporal Dementia with Granulin Mutation | A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating, Phase 2a Safety, Tolerability, and Pharmacodynamic Study of Two Doses of an Histone Deacetylase Inhibitor (FRM-0334) in Subjects with Prodromal to Moderate Frontotemporal Dementia with Granulin Mutation | Prodromal to Moderate Frontotemporal Dementia with Granulin Mutation MedDRA version: 18.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: FRM-0334 INN or Proposed INN: Histone Deacetylase Inhibitor Other descriptive name: EVP-0334 | FORUM Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | France;United States;Belgium;Netherlands;Italy;United Kingdom | ||
| 35 | EUCTR2014-002013-37-HR (EUCTR) | 04/03/2015 | 31/03/2015 | An open-label extension study evaluating the safety and tolerability of leuco-methylthioninium dihydromesylate (LMTM) in subjects with Alzheimer's Disease or a rare form of dementia (Behavioral Variant Frontotemporal Dementia) who have completed an earlier Phase trial | An Open-Label, Extension Study of the Effects of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Alzheimer’s Disease or Behavioral Variant Frontotemporal Dementia | Alzheimer’s Disease and behavioral variant Frontotemporal Dementia MedDRA version: 19.0;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0;Level: LLT;Classification code 10001896;Term: Alzheimer's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Leuco-methylthioninium bis(hydromethanesulfonate) Product Code: LMTM/TRx0237 INN or Proposed INN: N/A Other descriptive name: N,N,N',N'-tetramethyl-10H-phenothiazine-3,7-diaminium bis(methanesulfonate) | TauRx Therapeutics Ltd | NULL | Not Recruiting | Female: yes Male: yes | 966 | Phase 3 | United States;Taiwan;Finland;Spain;Russian Federation;United Kingdom;France;Canada;Argentina;Malaysia;Belgium;Singapore;Romania;Croatia;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 36 | EUCTR2014-001489-85-GB (EUCTR) | 23/02/2015 | 12/08/2014 | A study to investigate 2 doses of investigational drug on patients with Prodromal to Moderate Frontotemporal Dementia with Granulin Mutation | A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating, Phase 2a Safety, Tolerability, and Pharmacodynamic Study of Two Doses of an Histone Deacetylase Inhibitor (FRM-0334) in Subjects with Prodromal to Moderate Frontotemporal Dementia with Granulin Mutation | Prodromal to Moderate Frontotemporal Dementia with Granulin Mutation MedDRA version: 18.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | FORUM Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2;Phase 3 | France;United States;Belgium;Netherlands;Italy;United Kingdom | |||
| 37 | EUCTR2014-002013-37-ES (EUCTR) | 13/02/2015 | 16/12/2014 | An open-label extension study evaluating the safety and tolerability of leuco-methylthioninium dihydromesylate (LMTM) in subjects with Alzheimer's Disease or a rare form of dementia (Behavioral Variant Frontotemporal Dementia) who have completed an earlier Phase trial | An Open-Label, Extension Study of the Effects of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Alzheimer?s Disease or Behavioral Variant Frontotemporal Dementia | Alzheimer?s Disease and behavioral variant Frontotemporal Dementia MedDRA version: 17.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 17.1;Level: LLT;Classification code 10001896;Term: Alzheimer's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Leuco-methylthioninium bis(hydromethanesulfonate) Product Code: LMTM/TRx0237 INN or Proposed INN: N/A Other descriptive name: N,N,N',N'-tetramethyl-10H-phenothiazine-3,7-diaminium bis(methanesulfonate) | TauRx Therapeutics Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Phase 3 | United States;Taiwan;Finland;Spain;Russian Federation;Italy;United Kingdom;France;Canada;Argentina;Poland;Malaysia;Belgium;Singapore;Romania;Croatia;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of | ||
| 38 | EUCTR2014-001489-85-IT (EUCTR) | 22/12/2014 | 02/10/2014 | A study to investigate 2 doses of investigational drug on patients with Prodromal to Moderate Frontotemporal Dementia with Granulin Mutation | A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating, Phase 2a Safety, Tolerability, and Pharmacodynamic Study of Two Doses of an Histone Deacetylase Inhibitor (FRM-0334) in Subjects with Prodromal to Moderate Frontotemporal Dementia with Granulin Mutation | Prodromal to Moderate Frontotemporal Dementia with Granulin Mutation MedDRA version: 17.0;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: FRM-0334 INN or Proposed INN: Histone Deacetylase Inhibitor Other descriptive name: EVP-0334 | FORUM Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | France;United States;Belgium;Netherlands;United Kingdom;Italy | ||
| 39 | EUCTR2014-001489-85-NL (EUCTR) | 19/12/2014 | 23/09/2014 | A study to investigate 2 doses of investigational drug on patients with Prodromal to Moderate Frontotemporal Dementia with Granulin Mutation | A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating, Phase 2a Safety, Tolerability, and Pharmacodynamic Study of Two Doses of an Histone Deacetylase Inhibitor (FRM-0334) in Subjects with Prodromal to Moderate Frontotemporal Dementia with Granulin Mutation | Prodromal to Moderate Frontotemporal Dementia with Granulin Mutation MedDRA version: 18.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: FRM-0334 INN or Proposed INN: Histone Deacetylase Inhibitor Other descriptive name: EVP-0334 | FORUM Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | France;United States;Belgium;Netherlands;Italy;United Kingdom | ||
| 40 | EUCTR2014-001315-40-IT (EUCTR) | 03/12/2014 | 10/10/2014 | Florbetapir-PET scan in subjects with a known mutation for autosomal dominant Alzheimer's Disease taking part in the ItalianDIAfN study | Amyloid Imaging in the Italian Network for autosomal dominant Alzheimer’s disease and frontotemporal lobar degeneration (ItalianDIAfN)” - Amyloid-PET in ItalianDIAfN | Autosomal Dominant Alzheimer's Disease MedDRA version: 17.0;Level: LLT;Classification code 10001896;Term: Alzheimer's disease;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Amyvid Product Name: Florbetapir (18F) Product Code: Florbetapir (18F) INN or Proposed INN: florbetapir (18F) Other descriptive name: N/A | IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 41 | EUCTR2014-002013-37-GB (EUCTR) | 06/10/2014 | 20/08/2014 | An open-label extension study evaluating the safety and tolerability of leuco-methylthioninium dihydromesylate (LMTM) in subjects with Alzheimer's Disease or a rare form of dementia (Behavioral Variant Frontotemporal Dementia) who have completed an earlier Phase trial | An Open-Label, Extension Study of the Effects of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Alzheimer’s Disease or Behavioral Variant Frontotemporal Dementia | Alzheimer’s Disease and behavioral variant Frontotemporal Dementia MedDRA version: 19.0;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0;Level: LLT;Classification code 10001896;Term: Alzheimer's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | TauRx Therapeutics Ltd | NULL | Not Recruiting | Female: yes Male: yes | 966 | Phase 3 | United States;Taiwan;Finland;Spain;Russian Federation;United Kingdom;France;Canada;Malaysia;Belgium;Singapore;Romania;Croatia;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of | |||
| 42 | NCT02149160 (ClinicalTrials.gov) | October 2014 | 20/5/2014 | Study to Assess the Safety, Tolerability, and Pharmacodynamic (PD) Effects of FRM-0334 in Subjects With Prodromal to Moderate Frontotemporal Dementia With Granulin Mutation | A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating, Phase 2a Safety, Tolerability, and Pharmacodynamic Study of Two Doses of an Histone Deacetylase Inhibitor (FRM-0334) in Subjects With Prodromal to Moderate Frontotemporal Dementia With Granulin Mutation | Granulin Mutation | Drug: FRM-0334;Drug: Placebo | FORUM Pharmaceuticals Inc | NULL | Active, not recruiting | 21 Years | 75 Years | Both | 30 | Phase 2 | United States;Belgium;France;Italy;Netherlands;United Kingdom |
| 43 | EUCTR2014-000422-38-SE (EUCTR) | 19/09/2014 | 05/08/2014 | A study evaluating the diagnostic accuracy of [18F]-AV-1451 PET to detect and distinguish neurodegenerative disorders characterized by cerebral accumulation of the protein tau | An open-label study evaluating the diagnostic accuracy of [18F]-AV-1451 PET to detect and distinguish neurodegenerative disorders characterized by cerebral accumulation of tau | Neurodegenerative disorders with Tau-pathology; including Alzheimer's disease, progressive supranuclear palsy, frontotemporal dementia, corticobasal degeneration and important differential diagnostic conditions. MedDRA version: 17.0;Level: HLT;Classification code 10001897;Term: Alzheimer's disease (incl subtypes);System Organ Class: 10029205 - Nervous system disorders MedDRA version: 17.0;Level: PT;Classification code 10053643;Term: Neurodegenerative disorder;Level: LLT;Classification code 10009846;Term: Cognitive impairment;Classification code 10001896;Term: Alzheimer's disease;Classification code 10012285;Term: Dementia due to Pick's disease;Classification code 10012267;Term: Dementia;Classification code 10067889;Term: Dementia with Lewy bodies;Classification code 10036813;Term: Progressive supranuclear palsy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] | Product Name: 18F-AV-1451 | Skåne University Hospital, Region Skåne | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Sweden | ||||
| 44 | NCT02245568 (ClinicalTrials.gov) | August 2014 | 27/8/2014 | Open-Label Study of Leuco-methylthioninium Bis(Hydromethanesulfonate) (LMTM) in Subjects With Alzheimer's Disease or Behavioral Variant Frontotemporal Dementia (bvFTD) | An Open-Label, Extension Study of the Effects of LMTM in Subjects With Alzheimer's Disease or Behavioral Variant Frontotemporal Dementia (bvFTD) | Alzheimer's Disease;Behavioral Variant Frontotemporal Dementia | Drug: LMTM | TauRx Therapeutics Ltd | NULL | Terminated | N/A | N/A | All | 913 | Phase 3 | United States;Australia;Belgium;Canada;Croatia;Finland;France;Germany;Korea, Republic of;Malaysia;Netherlands;Romania;Russian Federation;Singapore;Spain;Taiwan;United Kingdom;Argentina;Bulgaria;Italy;Poland |
| 45 | EUCTR2011-005529-34-PL (EUCTR) | 11/06/2014 | 11/03/2014 | A comparison study of LMTM and placebo in patients with behavioral variant frontotemporal dementia | A Double-Blind, Placebo-Controlled, Randomized, Parallel Group, 12-Month Safety and Efficacy Trial of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Behavioral Variant Frontotemporal Dementia (bvFTD) - TRx-237-007 | behavioral variant Frontotemporal Dementia (bvFTD) MedDRA version: 18.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Leuco-methylthioninium bis(hydromethanesulfonate) Product Code: LMTM/TRx0237 INN or Proposed INN: N/A Other descriptive name: N,N,N’,N’-tetramethyl-10H-phenothiazine-3,7-diaminium bis(methanesulfonate) | TauRx Therapeutics Ltd | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | United States;Finland;Spain;United Kingdom;Italy;Canada;Poland;Singapore;Croatia;Romania;Australia;Germany;Netherlands | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 46 | EUCTR2011-005529-34-ES (EUCTR) | 07/05/2014 | 01/04/2014 | A comparison study of LMTM and placebo in patients with behavioral variant frontotemporal dementia | A Double-Blind, Placebo-Controlled, Randomized, Parallel Group, 12-Month Safety and Efficacy Trial of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Behavioral Variant Frontotemporal Dementia (bvFTD) - TRx-237-007 | behavioral variant Frontotemporal Dementia (bvFTD) MedDRA version: 16.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Leuco-methylthioninium bis(hydromethanesulfonate) Product Code: LMTM/TRx0237 INN or Proposed INN: N/A Other descriptive name: N,N,N?,N?-tetramethyl-10H-phenothiazine-3,7-diaminium bis(methanesulfonate) | TauRx Therapeutics Ltd | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | United States;Canada;Finland;Poland;Spain;Singapore;Croatia;Australia;Netherlands;Germany;Italy;United Kingdom | ||
| 47 | EUCTR2011-005529-34-HR (EUCTR) | 14/04/2014 | 03/09/2014 | A comparison study of LMTM and placebo in patients with behavioral variant frontotemporal dementia | A Double-Blind, Placebo-Controlled, Randomized, Parallel Group, 12-Month Safety and Efficacy Trial of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Behavioral Variant Frontotemporal Dementia (bvFTD) - TRx-237-007 | behavioral variant Frontotemporal Dementia (bvFTD) MedDRA version: 18.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Leuco-methylthioninium bis(hydromethanesulfonate) Product Code: LMTM/TRx0237 INN or Proposed INN: N/A Other descriptive name: N,N,N’,N’-tetramethyl-10H-phenothiazine-3,7-diaminium bis(methanesulfonate) | TauRx Therapeutics Ltd | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | United Kingdom;Italy;Canada;Poland;Singapore;Croatia;Romania;Australia;Germany;Netherlands;United States;Finland;Spain | ||
| 48 | EUCTR2011-005529-34-FI (EUCTR) | 04/04/2014 | 19/02/2014 | A comparison study of LMTM and placebo in patients with behavioral variant frontotemporal dementia | A Double-Blind, Placebo-Controlled, Randomized, Parallel Group, 12-Month Safety and Efficacy Trial of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Behavioral Variant Frontotemporal Dementia (bvFTD) - TRx-237-007 | behavioral variant Frontotemporal Dementia (bvFTD) MedDRA version: 17.0;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Leuco-methylthioninium bis(hydromethanesulfonate) Product Code: LMTM/TRx0237 INN or Proposed INN: N/A Other descriptive name: N,N,N’,N’-tetramethyl-10H-phenothiazine-3,7-diaminium bis(methanesulfonate) | TauRx Therapeutics Ltd | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | United States;Canada;Finland;Spain;Poland;Singapore;Croatia;Australia;Netherlands;Germany;Italy;United Kingdom | ||
| 49 | EUCTR2011-005529-34-IT (EUCTR) | 06/02/2014 | 30/12/2013 | A comparison study of LMTM and placebo in patients with behavioral variant frontotemporal dementia | A Double-Blind, Placebo-Controlled, Randomized, Parallel Group, 12-Month Safety and Efficacy Trial of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Behavioral Variant Frontotemporal Dementia (bvFTD) - TRx-237-007 | behavioral variant Frontotemporal Dementia (bvFTD) MedDRA version: 16.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Leuco-methylthioninium bis(hydromethanesulfonate) Product Code: LMTM/TRx0237 INN or Proposed INN: N/A Other descriptive name: N,N,N’,N’-tetramethyl-10H-phenothiazine-3,7-diaminium bis(methanesulfonate) | TauRx Therapeutics Ltd | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | United States;Canada;Finland;Spain;Poland;Singapore;Croatia;Australia;Netherlands;Germany;United Kingdom;Italy | ||
| 50 | NCT01937013 (ClinicalTrials.gov) | September 12, 2013 | 3/9/2013 | Impact of Emotional Mimicry and Oxytocin on Frontotemporal Dementia | Impact of Emotional Mimicry and Oxytocin on Frontotemporal Dementia | Frontotemporal Dementia | Drug: Intranasal oxytocin;Drug: Saline Nasal Mist | Lawson Health Research Institute | Canadian Institutes of Health Research (CIHR) | Completed | 30 Years | 85 Years | All | 52 | Phase 2 | Canada |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 51 | EUCTR2011-005529-34-NL (EUCTR) | 24/06/2013 | 09/08/2012 | A comparison study of LMTM and placebo in patients with behavioral variant frontotemporal dementia | A Double-Blind, Placebo-Controlled, Randomized, Parallel Group, 12-Month Safety and Efficacy Trial of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Behavioral Variant Frontotemporal Dementia (bvFTD) - TRx-237-007 | behavioral variant Frontotemporal Dementia (bvFTD) MedDRA version: 17.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Leuco-methylthioninium bis(hydromethanesulfonate) Product Code: LMTM/TRx0237 INN or Proposed INN: N/A Other descriptive name: N,N,N’,N’-tetramethyl-10H-phenothiazine-3,7-diaminium bis(methanesulfonate) | TauRx Therapeutics Ltd | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | United States;Canada;Finland;Spain;Poland;Singapore;Croatia;Australia;Germany;Netherlands;Italy;United Kingdom | ||
| 52 | NCT01626378 (ClinicalTrials.gov) | May 2013 | 20/6/2012 | Safety and Efficacy Study Evaluating TRx0237 in Subjects With Behavioral Variant Frontotemporal Dementia (bvFTD) | A Double-Blind, Placebo-Controlled, Randomized, Parallel Group, 12-Month Safety and Efficacy Trial of TRx0237 in Subjects With Behavioral Variant Frontotemporal Dementia (bvFTD) | Behavioral Variant Frontotemporal Dementia (bvFTD) | Drug: TRx0237;Drug: Placebo | TauRx Therapeutics Ltd | NULL | Completed | N/A | 79 Years | All | 220 | Phase 3 | United States;Australia;Canada;Croatia;Germany;Italy;Netherlands;Poland;Romania;Singapore;Spain;United Kingdom;Argentina;Bulgaria;Finland |
| 53 | EUCTR2012-004328-40-IT (EUCTR) | 01/03/2013 | 23/11/2012 | study of neuroinflammation in pathologies like Alzheimer, mild cognitive impairment, dementia and SLA | IMAGING OF NEUROINFLAMMATION IN NEURODEGENERATIVE DISEASES | mild cognitive impairment, Alzheimer disease,frontotemporal dementia, SLA MedDRA version: 14.1;Level: LLT;Classification code 10050727;Term: RI scan;System Organ Class: 100000004848;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: NA Product Code: (R)-[N-metil-11C1-PK11195(PK) | OSPEDALE S. RAFFAELE DI MILANO | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 54 | EUCTR2011-005529-34-GB (EUCTR) | 17/01/2013 | 08/08/2012 | A comparison study of LMTM and placebo in patients with behavioral variant frontotemporal dementia | A Double-Blind, Placebo-Controlled, Randomized, Parallel Group, 12-Month Safety and Efficacy Trial of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Behavioral Variant Frontotemporal Dementia (bvFTD) - TRx-237-007 | behavioral variant Frontotemporal Dementia (bvFTD) MedDRA version: 18.0;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Leuco-methylthioninium bis(hydromethanesulfonate) Product Code: LMTM/TRx0237 INN or Proposed INN: N/A Other descriptive name: N,N,N’,N’-tetramethyl-10H-phenothiazine-3,7-diaminium bis(methanesulfonate) | TauRx Therapeutics Ltd | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | United States;Finland;Spain;United Kingdom;Italy;Canada;Poland;Singapore;Croatia;Romania;Australia;Germany;Netherlands | ||
| 55 | EUCTR2011-005529-34-DE (EUCTR) | 28/12/2012 | 08/08/2012 | A comparison study of LMTM and placebo in patients with behavioral variant frontotemporal dementia | A Double-Blind, Placebo-Controlled, Randomized, Parallel Group, 12-Month Safety and Efficacy Trial of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Behavioral Variant Frontotemporal Dementia (bvFTD) - TRx-237-007 | behavioral variant Frontotemporal Dementia (bvFTD) MedDRA version: 18.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Leuco-methylthioninium bis(hydromethanesulfonate) Product Code: LMTM/TRx0237 INN or Proposed INN: N/A Other descriptive name: N,N,N’,N’-tetramethyl-10H-phenothiazine-3,7-diaminium bis(methanesulfonate) | TauRx Therapeutics Ltd | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | United States;Finland;Spain;United Kingdom;Italy;Canada;Poland;Singapore;Croatia;Romania;Australia;Germany;Netherlands | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 56 | EUCTR2011-004571-37-IT (EUCTR) | 21/02/2012 | 17/02/2012 | Amiodarone therapy for treatment of fontotemporat dementia caused by progranulin deficiency | - Rescue of Progranulin HaploInsufficiency in Frontotemporal Dementia - ReProIn-FTD | frontotemporal dementia associated to progranulin deficit MedDRA version: 14.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | INN or Proposed INN: AMIODARONE Other descriptive name: NA | AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 57 | NCT00604591 (ClinicalTrials.gov) | July 2011 | 19/1/2008 | Effects of Tolcapone on Frontotemporal Dementia | Investigation of the Dopamine System in Frontotemporal Dementia | Frontotemporal Lobar Degeneration | Drug: Tolcapone;Drug: Placebo | Columbia University | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | 40 Years | 85 Years | All | 28 | Phase 2 | United States |
| 58 | NCT01386333 (ClinicalTrials.gov) | June 2011 | 29/6/2011 | Safety Study of Intranasal Oxytocin in Frontotemporal Dementia | A Phase I Dose Finding Study of Intranasal Oxytocin in Frontotemporal Dementia, Protocol # FTDOXY10EF | Frontotemporal Dementia | Drug: oxytocin;Drug: Saline Nasal Mist | Lawson Health Research Institute | The Consortium of Canadian Centres for Clinical Cognitive Research (C5R) | Completed | 30 Years | 80 Years | Both | 23 | Phase 1 | Canada |
| 59 | JPRN-UMIN000003683 | 2010/06/01 | 31/05/2010 | The efficacy of ferulic acid in the treatment of dementia | Alzheimer's Disease, Dementia of Lewy Body,Vascular Dementia, Frontotemporal Dementia | Taking of Ferulic Acid for 6 months followed by Not taking of Ferulic Acid for 6 months. Not taking of Ferulic Acid for 6 months followed by taking of Ferulic Acid for 6 months. | Shimane University Hospital | NULL | Complete: follow-up complete | 20years-old | 90years-old | Male and Female | 50 | Not selected | Japan | |
| 60 | NCT01623284 (ClinicalTrials.gov) | March 2010 | 7/6/2012 | PiB PET Scanning in Speech and Language Based Dementias | PiB PET Scanning in Speech and Language Based Dementias | PPA;Primary Progressive Aphasia;Aphasia;Non-fluent Aphasia;Semantic Dementia;Apraxia of Speech;Primary Progressive Nonfluent Aphasia;Progressive Aphasia | Drug: C-11 PiB;Drug: F-18 FDG | Mayo Clinic | NULL | Completed | 18 Years | N/A | Both | 168 | Phase 1 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 61 | NCT01056965 (ClinicalTrials.gov) | January 2010 | 21/1/2010 | Davunetide (AL-108) in Predicted Tauopathies - Pilot Study | A 12 Week Randomized, Double Blind, Placebo-Controlled Pilot Study of Davunetide (NAP, AL-108) in Predicted Tauopathies | Predicted Tauopathies, Including;Progressive Supranuclear Palsy;Frontotemporal Dementia With Parkinsonism Linked to Chromosome 17;Corticobasal Degeneration Syndrome;Progressive Nonfluent Aphasia | Drug: davunetide (AL-108, NAP);Drug: Placebo nasal spray | University of California, San Francisco | NULL | Completed | 40 Years | 85 Years | All | 12 | Phase 1 | United States |
| 62 | NCT01002300 (ClinicalTrials.gov) | September 2009 | 23/10/2009 | Oxytocin and Social Cognition in Frontotemporal Dementia | Investigation of the Effects of Intranasal Oxytocin on Cognition and Emotion Processing in Frontotemporal Dementia | Frontotemporal Dementia;Pick's Disease | Drug: intranasal oxytocin | Lawson Health Research Institute | The Alzheimer Society London and Middlesex | Completed | 30 Years | 80 Years | Both | 24 | N/A | Canada |
| 63 | NCT01890343 (ClinicalTrials.gov) | September 2009 | 27/6/2013 | Imaging Characteristics of Florbetapir 18F in Patients With Frontotemporal Dementia, Alzheimer's Disease and Normal Controls. | A Study Evaluating the Imaging Characteristics of Florbetapir 18F (18F-AV-45) in Patients With Frontotemporal Dementia Compared to Patients With Alzheimer's Disease and Normal Controls. | Alzheimer's Disease;Frontotemporal Dementia | Drug: florbetapir 18F;Drug: 18F-FDG | Avid Radiopharmaceuticals | NULL | Completed | 45 Years | N/A | All | 34 | Phase 2 | United Kingdom |
| 64 | EUCTR2008-003597-18-GB (EUCTR) | 28/05/2009 | 14/04/2009 | Amyloid imaging in Alzheimer’s disease, frontotemporal dementia and healthy volunteers | A study evaluating the imaging characteristics of 18F-AV-45 in patients with frontotemporal dementia compared to patients with Alzheimer's disease and normal controls | Use of 18F-AV-45 positron emission tomography as early diagnostic technique in frontal lobe dementia and Alzheimer's disease. MedDRA version: 14.0;Level: PT;Classification code 10061816;Term: Diagnostic procedure;System Organ Class: 10022891 - Investigations | Avid Radiopharmaceuticals, Inc | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | United Kingdom | |||
| 65 | NCT00950430 (ClinicalTrials.gov) | April 2008 | 29/7/2009 | Imaging of Brain Amyloid Plaques in the Aging Population | Brain Amyloid Imaging With Pittsburgh Compound B in Normal Aging, Mild Cognitive Impairment, and Dementia | Alzheimer's Disease;Dementia With Lewy Bodies;Frontotemporal Dementia;Vascular Dementia | Drug: Pittsburgh Compound B (C-11 PiB);Drug: F-18 FDG;Drug: Tau (18-F-AV-1451) | Mayo Clinic | National Institute on Aging (NIA) | Enrolling by invitation | 30 Years | 100 Years | All | 2500 | Phase 4 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 66 | JPRN-UMIN000003239 | 2008/01/01 | 23/02/2010 | Influence of donepezil to behavioral and psychological symptoms of frontotemporal dementia | Frontotemporal dementia | Discontinuation of donepezil | National Hospital Organization Kikuchi Hospital | NULL | Complete: follow-up complete | 50years-old | 90years-old | Male and Female | 25 | Not selected | Japan | |
| 67 | NCT00594737 (ClinicalTrials.gov) | October 2007 | 7/1/2008 | Open Label Pilot Study of the Effects of Memantine on FDG-PET in Frontotemporal Dementia | An Open Label Pilot Study of the Effects of Memantine Administration on FDG-PET in Frontotemporal Dementia | Frontotemporal Dementia | Drug: memantine hydrochloride | Tiffany Chow, MD | H. Lundbeck A/S | Completed | 40 Years | 80 Years | Both | 17 | Phase 3 | Canada |
| 68 | NCT00545974 (ClinicalTrials.gov) | October 2007 | 16/10/2007 | Memantine (10mg BID) for the Frontal and Temporal Subtypes of Frontotemporal Dementia | A Prospective, Randomized, Multi-Center, Double-Blind, 26 Week, Placebo-Controlled Trial of Memantine (10mg BID) for the Frontal and Temporal Subtypes of Frontotemporal Dementia | Frontal Lobe Dementia;Frontotemporal Lobe Dementia;Semantic Dementia | Drug: memantine;Drug: Placebo pill | University of California, San Francisco | Forest Laboratories | Completed | 40 Years | 80 Years | All | 81 | Phase 4 | United States |
| 69 | NCT00376051 (ClinicalTrials.gov) | September 2006 | 13/9/2006 | Serotonergic Function and Behavioural and Psychological Symptoms of Frontotemporal Dementia | Serotonergic Function and Behavioural and Psychological Symptoms of Frontotemporal Dementia | Frontotemporal Dementia | Drug: Citalopram | Sunnybrook Health Sciences Centre | Alzheimer Society of Canada | Completed | 18 Years | N/A | All | 22 | Phase 4 | Canada |
| 70 | EUCTR2005-005915-13-GB (EUCTR) | 12/07/2006 | 10/04/2006 | An Open Pilot Study of Methlythioninium Chloride (MTC) in Frontotemporal Dementia and Related Dementia Syndromes - Pilot Stidy of MTC in FTD and related dementia syndromes | An Open Pilot Study of Methlythioninium Chloride (MTC) in Frontotemporal Dementia and Related Dementia Syndromes - Pilot Stidy of MTC in FTD and related dementia syndromes | Frontotemporal Dementia and related syndromes Prevention and reversal of tau protein aggregation is a novel approach to the treatment of patients with FTD and related syndromes and has the potential for slowing the disease process as well as providing symptomatic improvement in hitherto untreatable, ultimately fatal conditions. MedDRA version: 8.1;Level: PT;Classification code 10012267 | Product Name: Methylthioninium chloride Product Code: MTC TRx0014-001 capsules | TauRx Therapeutics PTE Ltd | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | United Kingdom | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 71 | NCT00127114 (ClinicalTrials.gov) | September 2005 | 3/8/2005 | Amantadine for the Treatment of Behavioral Disturbance in Frontotemporal Dementia (FTD) | Amantadine for the Treatment of Behavioral Disturbance in Frontotemporal Dementia (FTD) | Dementia | Drug: Amantadine;Drug: Placebo | Johns Hopkins University | NULL | Withdrawn | 40 Years | 90 Years | All | 0 | Phase 4 | United States |
| 72 | NCT00200538 (ClinicalTrials.gov) | September 2005 | 12/9/2005 | Efficacy and Tolerability of Memantine in Frontotemporal Dementia (FTD) Patients | Double-blind, Parallel Group, Placebo-controlled Trial of the Efficacy and Tolerability of Memantine (20 mg) in Frontotemporal Dementia (FTD) Patients | Dementia | Drug: memantine | Nantes University Hospital | NULL | Completed | 45 Years | 75 Years | Both | 52 | Phase 2 | France |
| 73 | NCT00187525 (ClinicalTrials.gov) | May 2004 | 13/9/2005 | A 52 Week Open Label Trial of Memantine for Frontotemporal Lobar Degeneration | Frontotemporal Lobar Degeneration | Drug: Memantine | University of California, San Francisco | Forest Laboratories | Completed | 40 Years | 80 Years | Both | Phase 4 | NULL | ||
| 74 | NCT00416169 (ClinicalTrials.gov) | May 2003 | 22/12/2006 | A Pilot Study to Explore the Safety and Tolerability of Galantamine HBr in the Treatment of Pick Complex/Frontotemporal Dementia | An Open Pilot Study to Evaluate the Safety and Efficacy of Galantamine in the Treatment of Pick's Disease/Frontotemporal Dementia /Pick Complex | Frontotemporal Dementia;Pick Complex | Drug: galantamine hydrobromide | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | NULL | Completed | 30 Years | 80 Years | Both | 41 | Phase 2 | NULL |