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NCT04747431 · ClinicalTrials.gov registry record · Phase 1
A Study of PBFT02 in Participants With FTD and Mutations in the Granulin Precursor (GRN) or C9ORF72 Genes
A Phase 1 study of Frontotemporal Dementia and FTD, sponsored by Passage Bio.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 10
- Study locations
NCT04747431 is a Phase 1 study of Frontotemporal Dementia and FTD that is actively recruiting participants, run by Passage Bio. The registered enrollment target is 30 participants, below the 1,196-participant average among 22 other Frontotemporal Dementia trials with a reported enrollment target (97% lower). The trial reports 10 study locations across 8 states.
The verdict
NCT04747431, a Phase 1 study of Frontotemporal Dementia and FTD, is actively recruiting participants, sponsored by Passage Bio.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 10
- Study locations
Study Summary
PBFT02 is a gene therapy for frontotemporal dementia intended to deliver a functional copy of the GRN gene to the brain. This study will assess the safety, tolerability and efficacy of this treatment in patients with frontotemporal dementia and mutations in the granulin precursor (GRN) or chromosome 9 open reading frame 72 (C9ORF72) genes
Conditions Studied
Interventions
- DRUG PBFT02
Study Locations (10)
Other
- Hospital das Clinicas da Universidade Federal de Minas Gerais (UFMG) - Minas Gerais
- Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo (HCFMUSP) - São Paulo
- Centro Hospitalar e Universitário de Coimbra - Coimbra
Michigan
- Michigan Alzheimer's Disease Center - Ann Arbor
Pennsylvania
- University of Pennsylvania - Philadelphia
Tennessee
- Vanderbilt University Medical Center - Nashville
Texas
- University of Texas at Houston - Houston
Victoria
- Eastern Health-Box Hill Hospital - Melbourne
Ontario
- University of Toronto, Toronto Western Hospital - Toronto
Quebec
- Montreal Neurological Institute-Hospital - Montreal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-09-14 |
| Est. Completion | 2031-08 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04747431
The ClinicalTrials.gov registry entry for NCT04747431 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,196-participant average among 22 other Frontotemporal Dementia trials with a reported enrollment target (97% lower). The listed sponsor is Passage Bio, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Frontotemporal Dementia appearing as the primary indexed condition, and to 1 intervention - of which PBFT02 is the first listed.
NCT04747431 reports 10 study locations spanning 8 distinct geographic areas - top geographies include Other, Michigan, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04747431 about?
NCT04747431 is a clinical study titled "A Study of PBFT02 in Participants With FTD and Mutations in the Granulin Precursor (GRN) or C9ORF72 Genes". PBFT02 is a gene therapy for frontotemporal dementia intended to deliver a functional copy of the GRN gene to the brain. This study will assess the safety, tolerability and efficacy of this treatment in patients with frontotemporal dementia and mutations in the granulin precursor (GRN) or chromosome...
What is the current status of trial NCT04747431?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2021-09-14. Estimated completion is 2031-08.
What conditions does trial NCT04747431 study?
This clinical trial studies the following conditions: Frontotemporal Dementia, FTD, FTD-GRN, Dementia, Frontotemporal, C9orf72.
What interventions are being tested in trial NCT04747431?
The interventions under investigation include: PBFT02 (DRUG).
Who is sponsoring clinical trial NCT04747431?
This trial is sponsored by Passage Bio, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04747431 being conducted?
This trial has 10 study locations across Michigan, Pennsylvania, Tennessee, Texas, Victoria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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