127. 前頭側頭葉変性症 Frontotemporal lobar degeneration Clinical trials / Disease details
臨床試験数 : 90 / 薬物数 : 87 - (DrugBank : 30) / 標的遺伝子数 : 39 - 標的パスウェイ数 : 88
| 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 | NCT05742698 (ClinicalTrials.gov) | June 2023 | 23/11/2022 | Nabilone for Agitation in Frontotemporal Dementia | Double Blind Crossover Clinical Trial of Nabilone for Agitation in Frontotemporal Dementia | Frontotemporal Dementia;Frontotemporal Dementia, Behavioral Variant;Primary Progressive Aphasia | Drug: Nabilone;Drug: Placebo | Simon Ducharme, MD | Alzheimer's Drug Discovery Foundation | Not yet recruiting | 18 Years | N/A | All | 45 | Phase 3 | NULL |
| 2 | NCT05683860 (ClinicalTrials.gov) | December 14, 2022 | 4/1/2023 | Open-label Extension (OLE) Study of WVE-004 in Patients With C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) and/or Frontotemporal Dementia (FTD) | A Multicenter, Open-label Extension (OLE) Study to Evaluate the Safety, Pharmacodynamics, and Clinical Effects of WVE-004 in Patients With C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) and/or Frontotemporal Dementia (FTD) | ALS;FTD | Drug: WVE-004 | Wave Life Sciences Ltd. | NULL | Enrolling by invitation | N/A | N/A | All | 42 | Phase 1/Phase 2 | Netherlands |
| 3 | NCT05456503 (ClinicalTrials.gov) | September 19, 2022 | 8/7/2022 | PET Imaging Tau Accumulation in FTLD and Atypical Alzheimer's Using PI-2620 | Imaging Tau Accumulation in FTLD and Atypical Alzheimer's Disease Using the PET Ligand PI-2620 | Frontotemporal Lobar Degeneration;Alzheimer Disease;Cognitively Normal | Drug: FPI-2620 | University of Pennsylvania | National Institutes of Health (NIH) | Recruiting | 45 Years | N/A | All | 54 | Phase 3 | United States |
| 4 | NCT05288842 (ClinicalTrials.gov) | September 6, 2022 | 27/7/2021 | Tanycytes in Alzheimer's Disease and Frontotemporal Dementia | TANYCYTES' ROLE IN ALZHEIMER'S DISEASE AND FRONTOTEMPORAL DEMENTIA: ARE THEY THE KEY TO WELL AGING? | Alzheimer Disease;Frontotemporal Dementia | Biological: Lumbar puncture;Biological: blood sample | University Hospital, Lille | European Research Council | Recruiting | 40 Years | 85 Years | All | 102 | France | |
| 5 | NCT05315661 (ClinicalTrials.gov) | July 6, 2022 | 1/3/2022 | The Safety and The Efficacy Evaluation of ET-STEM in Patients With Frontotemporal Dementia | Clinical Assessment on the Safety and Potential Efficacy of Mesenchymal Stem Cells Preconditioned With Ethionamide (ET-STEM) in Patients With Frontotemporal Dementia (FTD) | Frontotemporal Dementia | Drug: ET-STEM | Samsung Medical Center | NULL | Recruiting | 40 Years | 85 Years | All | 12 | Phase 1 | Korea, Republic of |
| 6 | NCT05184569 (ClinicalTrials.gov) | April 14, 2022 | 17/12/2021 | Veri-T: A Trial of Verdiperstat in Patients With svPPA Due to TDP-43 Pathology | Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy Study of Oral Verdiperstat (BHV-3241) in Patients With Semantic Variant Primary Progressive Aphasia (svPPA) Due to TDP-43 Pathology | Semantic Dementia | Drug: Verdiperstat | Peter Ljubenkov, MD | National Institutes of Health (NIH);Alzheimer's Association;National Institute on Aging (NIA) | Recruiting | 18 Years | 85 Years | All | 64 | Phase 1 | United States |
| 7 | NCT05262023 (ClinicalTrials.gov) | February 1, 2022 | 1/2/2022 | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL593 in Healthy Participants and Participants With Frontotemporal Dementia (FTD-GRN) | A Phase 1/2, Multicenter, Randomized, Placebo-Controlled, Double Blind Single Dose and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL593 in Healthy Participants and Participants With Frontotemporal Dementia Followed by an Open-Label Extension | Frontotemporal Dementia | Drug: DNL593;Drug: Placebo | Denali Therapeutics Inc. | Takeda | Recruiting | 18 Years | 80 Years | All | 106 | Phase 1/Phase 2 | Netherlands;Spain;Turkey;United Kingdom |
| 8 | EUCTR2021-002251-11-ES (EUCTR) | 31/01/2022 | 08/10/2021 | A clinical study to learn whether a new drug, TPN-101, is safe when given to patients with amyotrophic lateral sclerosis or frontotemporal dementia due to a genetic mutation called C9orf72 hexanucleotide repeat expansion. | A Phase 2a Study of TPN-101 in Patients with C9ORF72 ALS/FTD (Amyotrophic Lateral Sclerosis and/or Frontotemporal Dementia) | Amyotrophic lateral sclerosis or frontotemporal dementia due to a genetic mutation called C9orf72 hexanucleotide repeat expansion MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: TPN-101 Product Code: TPN-101 INN or Proposed INN: CENSAVUDINE | Transposon Therapeutics, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | France;United States;Canada;Belgium;Spain;Netherlands;Germany;United Kingdom | ||
| 9 | EUCTR2020-005193-94-SE (EUCTR) | 26/01/2022 | 12/10/2021 | Phase 1b/2a Study of WVE-004 in Patients with C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) or Frontotemporal Dementia (FTD) | A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-004 Administered Intrathecally to Patients with C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) or Frontotemporal Dementia (FTD) | Amyotrophic Lateral Sclerosis and Frontotemporal Dementia MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: WVE-004 INN or Proposed INN: not yet assigned Other descriptive name: Synthetic stereopure antisense oligonucleotide targeting human C9orf72 hexanucleotide repeat-containing mRNA transcripts | Wave Life Sciences UK Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 42 | Phase 1;Phase 2 | United States;Canada;Belgium;Ireland;Australia;Netherlands;Germany;United Kingdom;New Zealand;Sweden | ||
| 10 | EUCTR2020-005193-94-BE (EUCTR) | 26/01/2022 | 15/10/2021 | Phase 1b/2a Study of WVE-004 in Patients with C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) or Frontotemporal Dementia (FTD) | A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-004 Administered Intrathecally to Patients with C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) or Frontotemporal Dementia (FTD) | Amyotrophic Lateral Sclerosis and Frontotemporal Dementia MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: WVE-004 INN or Proposed INN: not yet assigned Other descriptive name: Synthetic stereopure antisense oligonucleotide targeting human C9orf72 hexanucleotide repeat-containing mRNA transcripts | Wave Life Sciences UK Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 42 | Phase 1;Phase 2 | United States;Canada;Belgium;Ireland;Australia;Netherlands;Germany;United Kingdom;New Zealand;Sweden | ||
| 11 | EUCTR2021-002251-11-DE (EUCTR) | 06/12/2021 | 02/08/2021 | A clinical study to learn whether a new drug, TPN-101, is safe when given to patients with amyotrophic lateral sclerosis or frontotemporal dementia due to a genetic mutation called C9orf72 hexanucleotide repeat expansion. | A Phase 2a Study of TPN-101 in Patients with C9ORF72 ALS/FTD (Amyotrophic Lateral Sclerosis and/or Frontotemporal Dementia) | Amyotrophic lateral sclerosis or frontotemporal dementia due to a genetic mutation called C9orf72 hexanucleotide repeat expansion MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: TPN-101 Product Code: TPN-101 INN or Proposed INN: CENSAVUDINE | Transposon Therapeutics, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | France;United States;Canada;Spain;Belgium;Netherlands;Germany;United Kingdom | ||
| 12 | NCT04993755 (ClinicalTrials.gov) | October 1, 2021 | 19/7/2021 | A Phase 2a Study of TPN-101 in Patients With C9ORF72 ALS/FTD | A Phase 2a Study of TPN-101 in Patients With Amyotrophic Lateral Sclerosis (ALS) and/or Frontotemporal Dementia (FTD) Associated With Hexanucleotide Repeat Expansion in the C9orf72 Gene (C9ORF72 ALS/FTD) | Amyotrophic Lateral Sclerosis;Frontotemporal Dementia | Drug: TPN-101, 400 mg/day;Drug: Placebo | Transposon Therapeutics, Inc. | NULL | Active, not recruiting | 18 Years | N/A | All | 42 | Phase 2 | United States;Belgium;France;Germany;Spain;Netherlands |
| 13 | NCT04747431 (ClinicalTrials.gov) | September 14, 2021 | 2/2/2021 | A Study of PBFT02 in Patients With Frontotemporal Dementia and Progranulin Mutations (FTD-GRN) | A Phase 1b Open-Label, Multicenter, Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacodynamic Effects of a Single Dose of PBFT02 Delivered Into the Cisterna Magna of Adult Subjects With Frontotemporal Dementia and Mutations in the Progranulin Gene | Frontotemporal Dementia | Drug: PBFT02 | Passage Bio, Inc. | NULL | Recruiting | 35 Years | 75 Years | All | 15 | Phase 1/Phase 2 | United States;Brazil;Canada;Italy;Portugal;United Kingdom |
| 14 | NCT04931862 (ClinicalTrials.gov) | June 28, 2021 | 11/6/2021 | Study of WVE-004 in Patients With C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) or Frontotemporal Dementia (FTD) | A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-004 Administered Intrathecally to Patients With C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) or Frontotemporal Dementia (FTD) | ALS;FTD | Drug: WVE-004;Drug: Placebo | Wave Life Sciences Ltd. | NULL | Active, not recruiting | 18 Years | 80 Years | All | 35 | Phase 1/Phase 2 | Australia;Belgium;Canada;Ireland;Netherlands;New Zealand;Sweden;United Kingdom |
| 15 | EUCTR2019-004066-18-FR (EUCTR) | 04/02/2021 | 30/06/2020 | 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 | United States;Portugal;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 16 | 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 | ||
| 17 | NCT04680130 (ClinicalTrials.gov) | November 1, 2020 | 3/11/2020 | Clinico-Pathologic-Genetic-Imaging Study of Neurodegenerative and Related Disorders | Clinico-Pathologic-Genetic-Imaging Study of Neurodegenerative and Related Disorders | PSP;CBD;PCA;LPA;Semantic Dementia;Semantic Aphasia;Behavioral Variant of Frontotemporal Dementia;FTD;PPA;Apraxia of Speech | Drug: C-11 PiB;Drug: AV1451 Tau | Mayo Clinic | NULL | Enrolling by invitation | 21 Years | N/A | All | 500 | United States | |
| 18 | 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: Latozinemab Other descriptive name: AL001 | Alector Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | United States;Portugal;Spain;Italy;United Kingdom;Switzerland;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 19 | 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;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Netherlands;Germany;Sweden | ||
| 20 | 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: Latozinemab Other descriptive name: AL001 | Alector Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | United States;Portugal;Spain;Italy;United Kingdom;Switzerland;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 21 | 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;Drug: Open label - AL001 | Alector Inc. | NULL | Recruiting | 25 Years | 85 Years | All | 180 | Phase 3 | United States;Argentina;Australia;Belgium;Canada;France;Germany;Greece;Italy;Netherlands;Portugal;Spain;Sweden;Switzerland;Turkey;United Kingdom |
| 22 | 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: Latozinemab Other descriptive name: AL001 | Alector Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | Portugal;Spain;Italy;United Kingdom;Switzerland;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden;United States | ||
| 23 | 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 | ||
| 24 | EUCTR2019-004066-18-IT (EUCTR) | 18/05/2020 | 15/06/2021 | 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. - NA | 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: AL001 | Alector Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | Germany;Netherlands;Sweden;United States;Portugal;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia | ||
| 25 | 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 | ||
| 26 | 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 |
| 27 | 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 | ||
| 28 | 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: Latozinemab 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 | ||
| 29 | EUCTR2019-000138-20-IT (EUCTR) | 24/09/2019 | 15/01/2021 | 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] | Alector Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 32 | Phase 2 | United States;Canada;Netherlands;Germany;United Kingdom;Italy | ||
| 30 | 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 | ||
| 31 | 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 | Suspended | 41 Years | 89 Years | All | 12 | Phase 2 | United States |
| 32 | 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 |
| 33 | 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 |
| 34 | 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 |
| 35 | 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 |
| 36 | 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 | Active, not recruiting | 30 Years | 80 Years | All | 112 | Phase 2 | United States;Canada |
| 37 | 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 |
| 38 | 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 |
| 39 | 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 |
| 40 | 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 | |||
| 41 | 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 | Completed | 40 Years | 85 Years | All | 17 | Phase 2 | United States |
| 42 | 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 | |||
| 43 | NCT02736695 (ClinicalTrials.gov) | July 2016 | 7/4/2016 | Assessment of Hyperphosphorylated Tau PET Binding in Primary Progressive Aphasia and Frontotemporal Dementia | Assessment of Hyperphosphorylated Tau PET Binding in Primary Progressive Aphasia and FTD | Primary Progressive Aphasia;Behavioral Variant of Frontotemporal Dementia;Frontotemporal Dementia, Behavioral Variant | Drug: F-18 AV 1451 | Mayo Clinic | NULL | Recruiting | 18 Years | N/A | All | 200 | N/A | United States |
| 44 | 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 |
| 45 | 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 | ||
| 46 | 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 | ||
| 47 | 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 | ||
| 48 | 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 | ||
| 49 | 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 | ||
| 50 | 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 | ||||
| 51 | 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] | 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 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Taiwan;Finland;Spain;Russian Federation;United Kingdom;France;Canada;Malaysia;Belgium;Singapore;Romania;Croatia;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of | ||
| 52 | 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 | ||||
| 53 | 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 |
| 54 | 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 |
| 55 | 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 |
| 56 | 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 | ||||
| 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 | JPRN-UMIN000003683 | 2010/06/01 | 31/05/2010 | The efficacy of ferulic acid in the treatment of dementia | The efficacy of ferulic acid in the treatment of dementia - EFATD | 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 |
| 59 | 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 |
| 60 | 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 |
| 61 | 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 |
| 62 | 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 | Product Name: florbetapir 18F Product Code: 18F-AV-45 Other descriptive name: florbetapir 18F Injection | Avid Radiopharmaceuticals, Inc | NULL | Not Recruiting | Female: yes Male: yes | 40 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 63 | 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 | 8000 | Phase 4 | United States |
| 64 | 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 |
| 65 | 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 |
| 66 | 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 |