Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2026-02-25 @ 9:45 PM
Study NCT ID:
NCT04629495
Status:
RECRUITING
Last Update Posted:
2025-09-03
First Post:
2020-11-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rapamycin - Effects on Alzheimer's and Cognitive Health
Sponsor:
The University of Texas Health Science Center at San Antonio
Organization:
Study Overview
Official Title:
Rapamycin - Effects on Alzheimer's and Cognitive Health (REACH)
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REACH
Brief Summary:
This study will evaluate the safety, tolerability, and feasibility of 12 month oral rapamycin treatment in older adults with amnestic mild cognitive impairment (aMCI) and early stage Alzheimer's disease (AD).
Detailed Description:
The study will consist of a screening/baseline period of up to 90 days pre-study drug, with a 12-month (+3 day) treatment period with rapamycin, followed by a post-treatment assessment completed within 14 days of the final study drug dose, and a final assessment conducted 6-months (+14 days) after the final study drug dose. The study duration is not expected to exceed 90 weeks for participants.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: