NCT04629495 · Phase 2 · ACTIVE NOT RECRUITING
Rapamycin - Effects on Alzheimer's and Cognitive Health
This Phase 2 trial is testing rapamycin, a drug already approved for organ transplant patients, to see if it is safe and tolerable for people with amnestic mild cognitive impairment or early Alzheimer's disease. Participants take oral rapamycin or a placebo daily for 12 months. Phase 2 means researchers are still evaluating safety and feasibility, not proving the drug works.
You may qualify if
- Both genders and all ethnic groups
- Ages 55 to 89 years
- 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)
- Amyloid positivity based on Amyloid PET Imaging
- 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 normalized ration (PT/PTT/INR) within normal limits
- A legally authorized representative (LAR) designated to sign informed consent (if necessary) must attend the Screening visit and accompany the participant to all remaining visits to provide reported outcomes
- Stable dose of AD medications (Donepezil, rivastigmine, Memantine, galantamine) for at least three months is allowed
You're excluded if
- Diabetes (HBA1c≥6.5% or antidiabetic medications)
- History of skin ulcers or poor wound healing
- Current tobacco or illicit drug use or alcohol abuse
- Use of anti-platelet or anti-coagulant medications other than aspirin
- Current medications that affect cytochrome 450 3A4 (CYP3A4)
- Immunosuppressant therapy within the last year
- Chemotherapy or radiation treatment within the last year
- Current or chronic history of liver or kidney disease or known hepatic or biliary abnormalities
- Untreated hypertriglyceridemia (fasting triglycerides \< 250 mg/dl)
- Current or chronic history of pulmonary disease or abnormal pulse oximetry (\<90%)
- Chronic heart failure
- Pregnancy or lactation
- Recent history (past six months) of myocardial infarction, active coronary artery disease, intestinal disorders, stroke, or transient ischemic attack
- Significant neurological conditions other than AD or MCI
- Poorly controlled blood pressure (systolic BP>160, diastolic BP>90 mmHg - based on two readings)
- Active inflammatory, COVID-19, autoimmune, infectious, hepatic, gastrointestinal, malignant, and/or severe mental illness
- History of, or MRI, or CT positive for, any space occupying lesion, including mass effect or abnormal intracranial pressure, which would indicate contraindications to lumbar puncture
- Organ transplant recipients
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-06-09