Rapamycin - Effects on Alzheimer's and Cognitive Health

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Mild Cognitive Impairment, Alzheimer Disease

In brief

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).

Key facts

Study ID

NCT04629495

Run by

The University of Texas Health Science Center at San Antonio

People needed

40

Starts

2021-08-11

Expected to finish

2027-03-05

Last updated by the study team

2026-06-09

Who can join

Age: 55 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

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 may not qualify 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

Where it is running

• Glenn Biggs Institute for Alzheimer's & Neurodegenerative Diseases — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.