RecruitingPhase 2NCT04629495

Rapamycin - Effects on Alzheimer's and Cognitive Health

Rapamycin - Effects on Alzheimer's and Cognitive Health (REACH)

Sponsor

The University of Texas Health Science Center at San Antonio

Enrollment

40 participants

Start Date

Aug 11, 2021

Study Type

INTERVENTIONAL

Conditions

Alzheimer Disease Mild Cognitive Impairment

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).

Eligibility

Min Age: 55 YearsMax Age: 89 Years

Inclusion Criteria7

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

Exclusion Criteria18

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