NCT04629495

Rapamycin - Effects on Alzheimer's and Cognitive Health

Rapamycin - Effects on Alzheimer's and Cognitive Health (REACH)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 55 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mild Cognitive Impairment
• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	Rapamycin	RAPA will be administered orally 1mg daily
OTHER	Placebo	Placebo will be administered orally once daily

Timeline

• Start date: 2021-08-11
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2020-11-16
• Last updated: 2025-09-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study