Rapamycin - Effects on Alzheimer's and Cognitive Health (REACH)
The University of Texas Health Science Center at San Antonio
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).
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.
Eligibility
- Age range
- 55–89 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Both genders and all ethnic groups 2. Ages 55 to 89 years 3. Diagnosis of MCI or AD (Mini Mental Status Examination (MMSE): 18-30; Clinical Dementia Rating Scale (CDR) = 0.5 - 1; California Verbal Learning Test III (CVLT-III) Delayed Recall ≤16% based on age-adjusted norms, clinician approval) 4. Amyloid positivity based on Amyloid PET Imaging 5. Labs: Normal blood cell counts without clinically significant excursions; normal liver and renal function; and glucose control (HbA1c \< 6.5%). Fasting lipid panel and prothrombin time/prothrombin time test/international normal…
Interventions
- DrugRapamycin
RAPA will be administered orally 1mg daily
- OtherPlacebo
Placebo will be administered orally once daily
Location
- Glenn Biggs Institute for Alzheimer's & Neurodegenerative DiseasesSan Antonio, Texas