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NCT06064890 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Safety and Effect of AVB-101, a Gene Therapy Product, in Subjects With a Genetic Sub-type of Frontotemporal Dementia (FTD-GRN)
A Phase 1 study of Frontotemporal Dementia and FTD, sponsored by AviadoBio.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
- 19
- Study locations
NCT06064890 is a Phase 1 study of Frontotemporal Dementia and FTD that is actively recruiting participants, run by AviadoBio. The registered enrollment target is 9 participants, below the 1,197-participant average among 22 other Frontotemporal Dementia trials with a reported enrollment target (99% lower). The trial reports 19 study locations across 5 states.
The verdict
NCT06064890, a Phase 1 study of Frontotemporal Dementia and FTD, is actively recruiting participants, sponsored by AviadoBio.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
- 19
- Study locations
Study Summary
The goal of this clinical study is to learn about an investigational gene therapy product called AVB-101, which is designed to treat a disease called Frontotemporal Dementia with Progranulin Mutations (FTD-GRN). FTD-GRN is an early-onset form of dementia, a progressive brain disorder that affects behavior, language and movement. These symptoms result from below normal levels of a protein called progranulin (PGRN) in the brain, which leads to the death of nerve cells (neurons), affecting the brain's ability to function. The main questions that the study aims to answer are: 1. Is a one-time treatment with AVB-101 safe for patients with FTD-GRN? 2. Does a one-time treatment with AVB-101 restore PGRN levels to at least normal levels? 3. Could AVB-101 work as a treatment to slow down or stop progression of FTD-GRN? In this study there is no placebo (a dummy pill or treatment used for comparison purposes), so all participants will receive a one-time treatment of AVB-101 delivered directly to the brain, with follow-up assessments for 5 years.
Conditions Studied
Interventions
- PROCEDURE Intrathalamic AAV.PGRN administration
- GENETIC Intrathalamic AVB-101
Study Locations (19)
Other
- UZ Leuven - Leuven
- Fondazione IRCCS Istituto Neurologico Carlo Besta - Milan
- Amsterdam UMC - Amsterdam
- NEURO-CARE Sp. z o.o. Sp. Komandytowa - Katowice
- Neurologia Slaska Centrum Medyczne - Katowice
- Uniwersyteckie Centrum Kliniczne, SUM w Katowicach - Katowice
- Euromedis Sp. z o.o. - Szczecin
- Centrum Medyczne NeuroProtect Sp z o.o. - Warsaw
- Mazowiecki Szpital Brodnowski Sp. z o. o. - Warsaw
- Hospital Clinic Barcelona - Barcelona
- Hospital Universitari i Politecnic La Fe - Valencia
- Skåne University Hospital - Lund
- Cambridge University Hospitals NHS Foundation Trust - Cambridge
- University Hospital of Wales - Cardiff
- University College London Hospitals - London
Ohio
- The Ohio State University (OSU) Wexner Medical Center - Columbus
Tennessee
- Vanderbilt University Medical Centre - Nashville
Texas
- Houston Methodist Hospital - Houston
Ontario
- Sunnybrook Health Sciences Centre - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2023-08-30 |
| Est. Completion | 2030-03-21 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06064890
The ClinicalTrials.gov registry entry for NCT06064890 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,197-participant average among 22 other Frontotemporal Dementia trials with a reported enrollment target (99% lower). The listed sponsor is AviadoBio, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Frontotemporal Dementia appearing as the primary indexed condition, and to 2 interventions - of which Intrathalamic AAV.PGRN administration is the first listed.
NCT06064890 reports 19 study locations spanning 5 distinct geographic areas - top geographies include Other, Ohio, Tennessee.
Frequently Asked Questions
What is clinical trial NCT06064890 about?
NCT06064890 is a clinical study titled "A Study to Evaluate the Safety and Effect of AVB-101, a Gene Therapy Product, in Subjects With a Genetic Sub-type of Frontotemporal Dementia (FTD-GRN)". The goal of this clinical study is to learn about an investigational gene therapy product called AVB-101, which is designed to treat a disease called Frontotemporal Dementia with Progranulin Mutations (FTD-GRN). FTD-GRN is an early-onset form of dementia, a progressive brain disorder that affects be...
What is the current status of trial NCT06064890?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2023-08-30. Estimated completion is 2030-03-21.
What conditions does trial NCT06064890 study?
This clinical trial studies the following conditions: Frontotemporal Dementia, FTD, FTD-GRN, Dementia, Frontotemporal.
What interventions are being tested in trial NCT06064890?
The interventions under investigation include: Intrathalamic AAV.PGRN administration (PROCEDURE), Intrathalamic AVB-101 (GENETIC).
Who is sponsoring clinical trial NCT06064890?
This trial is sponsored by AviadoBio, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06064890 being conducted?
This trial has 19 study locations across Ohio, Tennessee, Texas, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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