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Clinical Trial Report

Gene Therapy Trial Report

Summary

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


NCTID NCT05040217 (View at clinicaltrials.gov)
Description
Indication Alzheimer's Disease, Mild Cognitive Impairment
Compound Name AAV2-BDNF
Sponsor Mark Tuszynski
Funder Type Other
Status
Recruiting
Enrollment Count 12

Therapy Information


Target Gene/Variant BDNF
Therapy Type Gene transfer
Therapy Route In-vivo
Mechanism of Action Overexpression of protective allele/gene
Route of Administration Intraparenchymal
Drug Product Type Viral vector
Target Tissue/Cell Entorhinal cortex & hippocampus
Delivery System Viral transduction
Vector Type AAV2
Editor Type none
Dose 1 3E11 vg/mL
Dose 2 1E12 vg/mL
Dose 3
Dose 4
Dose 5

Study Record Dates


Current Stage Phase1
Submit Date 2021-06-21
Completion Date 2027-10-01
Last Update 2024-08-27

Participation Criteria


Eligible Age 50 Years - 80 Years
Standard Ages Adult, Older adult
Eligible Sex ALL

Locations


No.of Trial Sites 2
Locations United States

Regulatory Information


Has US IND True
Recent Updates Surgical treatment of the AD patients will be complete in December 2024, and the MCI cohort is expected be completed in 2025

Resources/Links