A Clinical Trial of AAV2-BDNF Gene Therapy in Early Alzheimer's Disease and Mild Cognitive Impairment

Part of paid clinical trials in La Jolla, California.

Sponsor
Mark Tuszynski
Study ID
NCT05040217
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • AAV2-BDNF Gene Therapy — GENETIC
    AAV2-BDNF is a genetically engineered adeno-associated virus serotype 2 (AAV-2) that expresses the human BDNF cDNA.
  • AAV2-BDNF Gene Therapy — BIOLOGICAL
    Gene therapy is a biological therapy delivering the BDNF gene to the brain

Study Details

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.

Key Dates

Start date
Feb 7, 2022
Status verified
Oct 2025
Primary completion
Dec 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Gene transfer of AAV2-BDNF
    Up to 12 subjects will receive open-label AAV2-BDNF

Primary Outcome Measure

Safety as assessed by mumber of participants with treatment-related adverse events assessed on MRI scan [ Time Frame: 24 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of California - San DiegoLa JollaCalifornia92093
Laura Linares, MS
[email protected]
858-246-2317
Lori Graham
[email protected]
858-534-8857
Gabriel Leger, MD (PRINCIPAL_INVESTIGATOR)
The Ohio State UniversityColumbusOhio43210
Andrea Davis, MS
[email protected]
614-688-6412
Jennifer Icenhour
[email protected]
6142936882
James B Elder, MD (PRINCIPAL_INVESTIGATOR)
Doug Scharre, MD (SUB_INVESTIGATOR)

Find similar trials in La Jolla, CA

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
University of California - San Diego· La Jolla, CAThe Ohio State University· Columbus, OH

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