Rapamycin - Effects on Alzheimer's and Cognitive Health

Eligibility 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 normalized ration (PT/PTT/INR) within normal limits
• 6. 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
• 7. Stable dose of AD medications (Donepezil, rivastigmine, Memantine, galantamine) for at least three months is allowed
• 1. Diabetes (HBA1c≥6.5% or antidiabetic medications)
• 2. History of skin ulcers or poor wound healing
• 3. Current tobacco or illicit drug use or alcohol abuse
• 4. Use of anti-platelet or anti-coagulant medications other than aspirin
• 5. Current medications that affect cytochrome 450 3A4 (CYP3A4)
• 6. Immunosuppressant therapy within the last year
• 7. Chemotherapy or radiation treatment within the last year
• 8. Current or chronic history of liver or kidney disease or known hepatic or biliary abnormalities
• 9. Untreated hypertriglyceridemia (fasting triglycerides \< 250 mg/dl)
• 10. Current or chronic history of pulmonary disease or abnormal pulse oximetry (\<90%)
• 11. Chronic heart failure
• 12. Pregnancy or lactation
• 13. Recent history (past six months) of myocardial infarction, active coronary artery disease, intestinal disorders, stroke, or transient ischemic attack
• 14. Significant neurological conditions other than AD or MCI
• 15. Poorly controlled blood pressure (systolic BP\>160, diastolic BP\>90 mmHg - based on two readings)
• 16. Active inflammatory, COVID-19, autoimmune, infectious, hepatic, gastrointestinal, malignant, and/or severe mental illness
• 17. 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
• 18. Organ transplant recipients