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NCT05040217 · ClinicalTrials.gov registry record · Phase 1
A Clinical Trial of AAV2-BDNF Gene Therapy in Early Alzheimer's Disease and Mild Cognitive Impairment
A Phase 1 study of Mild Cognitive Impairment and Alzheimers Disease, sponsored by Mark Tuszynski.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 2
- Study locations
NCT05040217: Recruiting Phase 1 study of Mild Cognitive Impairment and Alzheimers Disease, sponsored by Mark Tuszynski.
NCT05040217 is a Phase 1 study of Mild Cognitive Impairment and Alzheimers Disease that is actively recruiting participants, run by Mark Tuszynski. The registered enrollment target is 12 participants, below the 1,270-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05040217, a Phase 1 study of Mild Cognitive Impairment and Alzheimers Disease, is actively recruiting participants, sponsored by Mark Tuszynski.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a first-in-human clinical trial to test whether a protein administered into the brain continuously by gene therapy, Brain-Derived Neurotrophic Factor (BDNF), will slow or prevent cell loss in the brains of people affected by Alzheimer's disease and Mild Cognitive Impairment. The protein may also activate cells in the brain that have not yet deteriorated. Gene therapy refers to the use of a harmless virus to have brain cells make the potentially protective protein, BDNF.
Primary Outcome
Number of participants with treatment-related adverse events assessed on MRI scan
Conditions Studied
Interventions
- GENETIC AAV2-BDNF Gene Therapy
- BIOLOGICAL AAV2-BDNF Gene Therapy
Study Locations (2)
California
- University of California - San Diego - La Jolla
Ohio
- The Ohio State University - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2022-02-07 |
| Est. Completion | 2027-12-01 |
| Phase | Phase 1 |
What NCT05040217 shows while recruiting
NCT05040217 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 1,270-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Mild Cognitive Impairment appearing as the primary indexed condition, and to 2 interventions - of which AAV2-BDNF Gene Therapy is the first listed.
NCT05040217 reports a single indexed study location in California, Ohio.
Frequently Asked Questions
What is clinical trial NCT05040217 about?
NCT05040217 is a clinical study titled "A Clinical Trial of AAV2-BDNF Gene Therapy in Early Alzheimer's Disease and Mild Cognitive Impairment". This is a first-in-human clinical trial to test whether a protein administered into the brain continuously by gene therapy, Brain-Derived Neurotrophic Factor (BDNF), will slow or prevent cell loss in the brains of people affected by Alzheimer's disease and Mild Cognitive Impairment. The protein may ...
What is the current status of trial NCT05040217?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2022-02-07. Estimated completion is 2027-12-01.
What conditions does trial NCT05040217 study?
This clinical trial studies the following conditions: Mild Cognitive Impairment, Alzheimers Disease.
What interventions are being tested in trial NCT05040217?
The interventions under investigation include: AAV2-BDNF Gene Therapy (GENETIC), AAV2-BDNF Gene Therapy (BIOLOGICAL).
Who is sponsoring clinical trial NCT05040217?
This trial is sponsored by Mark Tuszynski, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05040217 being conducted?
This trial has 2 study locations across California, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Mild Cognitive Impairment
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05040217's enrollment target sits among peer trials
12 196th of 205 higher than 9 of 205 other Mild Cognitive Impairment trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mild Cognitive Impairment 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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