NCT04200911

Cognition, Age, and RaPamycin Effectiveness - DownregulatIon of thE mTor Pathway

Cognition, Age, and RaPamycin Effectiveness - DownregulatIon of thE mTor Pathway (CARPE DIEM)

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 55 Years – 85 Years
• Healthy volunteers: Accepted

Summary

Evaluation of central nervous system penetration of orally administered Rapamune (RAPA) in older adults with Mild Cognitive Impairment (MCI) or early Alzheimer's disease (AD) and investigate associated safety, tolerability, target engagement, cognition, and functional status as initial proof-of-concept study

Detailed description

This study is an open-label pilot study of orally administered RAPA to measure its target engagement in Cerebrospinal Fluid (CSF) and blood, and to establish the feasibility and safety of RAPA treatment in older adults with MCI and early stage AD as initial proof-of-concept for a larger Phase 2 clinical trial.

Conditions

• Cognitive Impairment, Mild
• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	Rapamune	Sirolimus 1mg capsules

Timeline

• Start date: 2020-06-01
• Primary completion: 2022-01-13
• Completion: 2022-01-13
• First posted: 2019-12-16
• Last updated: 2025-01-08
• Results posted: 2023-03-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study