Award
NIH Reporter #5R01AG063826-05
Allopregnanolone as Regenerative Therapeutic for Alzheimer's: Phase 2 Clinical Trial
Recipient
National Institute on Aging (NIA)
Award Amount
$6,580,973.00
Ceiling
$6,580,973.00
Awarded
July 11, 2025
Identifier
5R01AG063826-05
NIH awarded a grant for a Phase 2 clinical trial studying Allopregnanolone as a regenerative therapeutic for Alzheimer's disease, focusing on clinical outcomes and biomarker development.
Description
The project involves a Phase 2 clinical trial of Allopregnanolone (Allo) for Alzheimer's disease. The trial includes a placebo-controlled period of 12 months followed by a 6-month open-label period. The primary outcome is the rate of change in ADAS-cog14 score. The project aims to develop MRI-based biomarkers and blood-based predictive biomarkers. The project is funded by the National Institute on Aging.