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Rapamycin - Effects on Alzheimer's and Cognitive Health
NCT04629495Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Aug 2021
- Primary completion
- Mar 2026
- Countries
- 1
- Sponsor
- UT Health San Antonio
- Modality
- Small Molecules
- Drugs
- sirolimus
- Conditions
- Mild Cognitive Impairment (MCI)Alzheimer's disease (AD)
01
Overview
Phase 2, randomised trial in Mild Cognitive Impairment (MCI) and Alzheimer's disease (AD) comparing RAPA (rapamycin) treatment group with Placebo group (2 arms). Primary endpoints: Number of adverse events at 12 months, Change in glucose level at 12 months and 3 more. Started Aug 2021; status: active, not recruiting.
02
Design
2 arms- Study design
- Randomized
RAPA (rapamycin) treatment group
Subjects will receive active drug (Rapamycin 1mg daily orally)
Placebo group
Subjects will receive placebo orally once daily
03
Who it enrols
Older adults aged 55-89 with aMCI or early AD, amyloid positivity on PET, normal lab values, and no significant uncontrolled medical conditions or interacting medications.
04
Endpoints
Primary
Number of adverse events
Change in glucose level
Change in albumin
Change in carbon dioxide or bicarbonate (CO2)
Change in calcium
Secondary
Central nervous system penetration of rapamycin
Change in Cognition using preclinical Alzheimer's Cognitive Composite 5
Change in Cognition using Clinical Dementia Rating Scale sum of Boxes
Change in Functional status
Change in Neuropsychiatric symptoms
Change in Gait Speed
Change in Grip Strength
Change in CSF amyloid beta
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