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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 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.

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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.

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

FieldValue
Enrollment Target 12 participants
Start Date 2022-02-07
Est. Completion 2027-12-01
Phase Phase 1

Sponsor

Mark Tuszynski

1 total trials

What the Registry Record Tells You About NCT05040217

The ClinicalTrials.gov registry entry for NCT05040217 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,270-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (99% lower). The listed sponsor is Mark Tuszynski, which has 1 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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