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NCT04408625 · ClinicalTrials.gov registry record · Phase 1
Phase 1/2 Clinical Trial of LY3884963 in Patients With Frontotemporal Dementia With Progranulin Mutations (FTD-GRN)
A Phase 1 study of Frontotemporal Dementia, sponsored by Prevail Therapeutics.
- Active
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
- 12
- Study locations
NCT04408625: Active Phase 1 study of Frontotemporal Dementia, sponsored by Prevail Therapeutics.
NCT04408625 is a Phase 1 study of Frontotemporal Dementia that is active but no longer recruiting, run by Prevail Therapeutics. The registered enrollment target is 35 participants, below the 1,196-participant average among 22 other Frontotemporal Dementia trials with a reported enrollment target (97% lower). The trial reports 12 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04408625, a Phase 1 study of Frontotemporal Dementia, is active but no longer recruiting, sponsored by Prevail Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
- 12
- Study locations
Study Summary
Study J4B-MC-OKAA is a Phase 1/2, multi-center, open-label ascending dose, first-in-human study that will evaluate the safety and effect of intra-cisternal LY3884963 administration on progranulin protein (PGRN) levels in patients with frontotemporal dementia with progranulin mutations (FTD-GRN). Two escalating dose (low dose and medium dose) cohorts are planned, as well as one bridging cohort which will allocate patients to receive either low or medium dose. The duration of the study is 5 years. During the first year, patients will be evaluated for the effect of LY3884963 on safety, tolerability, immunogenicity, biomarkers, and efficacy. Patients will follow up for an additional 4 years to monitor safety and changes on selected biomarkers and clinical outcomes.
Conditions Studied
Interventions
- DRUG Methylprednisolone
- BIOLOGICAL LY3884963
- DRUG Optional Sirolimus
- DRUG Optional Prednisone
Study Locations (12)
Other
- UZ Leuven, Neurologie Herestraat 49 - Leuven
- Centre Mémoire de Ressources - Lille
- Le Ber, Institut du Cerveau et de la Moelle Epinière - Paris
- Hospital Clinic de Barcelona, Villaroel 170 Servicio de Neurología - Barcelona
- Hospital Universitario de Donostia, Servicio De Neurologia, Consultas Externas Neurologia, San Sebastian, Guipúzcoa - Donostia / San Sebastian
- University College London,Queen Square, Dementia Research Building, London, - London
Florida
- k2 Medical Research-Maitland - Maitland
- PPD Phase 1 Clinic, 100 West Gore Street, Suite 202 - Orlando
Massachusetts
- Lahey Hospital & Medical Center, 41 Burlington Mall Road - Burlington
Pennsylvania
- Hospital of the University of Pennsylvania, 3 West Gates Building, 3400 Spruce Street - Philadelphia
New South Wales
- Royal Prince Alfred Hospital, Brain & Mind Research Institute, 94 Mallet Street - Camperdown
Marseille
- AP-HM Hôpital de La Timone - Saint-Pierre
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2020-11-09 |
| Est. Completion | 2029-11-30 |
| Phase | Phase 1 |
What the registry record for NCT04408625 still lists
NCT04408625 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 1,196-participant average among 22 other Frontotemporal Dementia trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Frontotemporal Dementia appearing as the primary indexed condition, and to 4 interventions - of which Methylprednisolone is the first listed.
NCT04408625 lists 12 locations in 6 states (Other, Florida, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT04408625 about?
NCT04408625 is a clinical study titled "Phase 1/2 Clinical Trial of LY3884963 in Patients With Frontotemporal Dementia With Progranulin Mutations (FTD-GRN)". Study J4B-MC-OKAA is a Phase 1/2, multi-center, open-label ascending dose, first-in-human study that will evaluate the safety and effect of intra-cisternal LY3884963 administration on progranulin protein (PGRN) levels in patients with frontotemporal dementia with progranulin mutations (FTD-GRN). Two...
What is the current status of trial NCT04408625?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2020-11-09. Estimated completion is 2029-11-30.
What conditions does trial NCT04408625 study?
This clinical trial studies the following conditions: Frontotemporal Dementia.
What interventions are being tested in trial NCT04408625?
The interventions under investigation include: Methylprednisolone (DRUG), LY3884963 (BIOLOGICAL), Optional Sirolimus (DRUG), Optional Prednisone (DRUG).
Who is sponsoring clinical trial NCT04408625?
This trial is sponsored by Prevail Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04408625 being conducted?
This trial has 12 study locations across Florida, Massachusetts, Pennsylvania, New South Wales, Marseille. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04408625's enrollment target sits among peer trials
35 20th of 22 higher than 3 of 22 other Frontotemporal Dementia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Frontotemporal Dementia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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