Actively Recruiting
Rapamycin - Effects on Alzheimer's and Cognitive Health
Led by The University of Texas Health Science Center at San Antonio · Updated on 2025-09-03
40
Participants Needed
1
Research Sites
237 weeks
Total Duration
On this page
Sponsors
T
The University of Texas Health Science Center at San Antonio
Lead Sponsor
A
Alzheimer's Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Rapamycin - Effects on Alzheimer's and Cognitive Health
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Both genders and all ethnic groups
- Age between 55 and 89 years
- Diagnosis of mild cognitive impairment or Alzheimer's disease with MMSE 18-30, CDR 0.5-1, and CVLT-III delayed recall ≤16% based on age norms with clinician approval
- Amyloid positivity confirmed by amyloid PET imaging
- Normal blood cell counts and liver, kidney function; glucose control with HbA1c < 6.5%; normal fasting lipid panel and coagulation tests
- Legally authorized representative available to provide consent and attend visits if needed
- Stable dose of Alzheimer's medications for at least 3 months allowed
You will not qualify if you...
- Diabetes with HbA1c ≥ 6.5% or use of antidiabetic medications
- History of skin ulcers or poor wound healing
- Current tobacco, illicit drug use, or alcohol abuse
- Use of antiplatelet or anticoagulant drugs other than aspirin
- Use of medications affecting CYP3A4 enzyme
- Immunosuppressant therapy in the past year
- Chemotherapy or radiation therapy in the past year
- Current or chronic liver or kidney disease or known biliary abnormalities
- Untreated high triglycerides (fasting triglycerides ≥ 250 mg/dl)
- Current or chronic lung disease or pulse oximetry < 90%
- Chronic heart failure
- Pregnancy or breastfeeding
- Recent (past 6 months) heart attack, coronary artery disease, intestinal disorders, stroke, or transient ischemic attack
- Significant neurological conditions other than AD or MCI
- Poorly controlled blood pressure (systolic >160 or diastolic >90 mmHg)
- Active inflammatory, COVID-19, autoimmune, infectious, hepatic, gastrointestinal, malignant, or severe mental illness
- History or imaging evidence of brain lesions contraindicating lumbar puncture
- Organ transplant recipients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Glenn Biggs Institute for Alzheimer's & Neurodegenerative Diseases
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
S
Sudha Seshadri, MD
CONTACT
F
Floyd A Jones
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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