Purpose

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

Eligibility

Eligible Ages
Between 55 Years and 89 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion 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

Exclusion Criteria

  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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
placebo controlled study
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Quadruple-blind

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
RAPA (rapamycin) treatment group
Subjects will receive active drug
  • Drug: Rapamycin
    RAPA will be administered orally 1mg daily
    Other names:
    • Sirolimus, RAPA
Placebo Comparator
Placebo group
Subjects will receive placebo
  • Other: Placebo
    Placebo will be administered orally once daily
    Other names:
    • Placebo capsule

Recruiting Locations

Glenn Biggs Institute for Alzheimer's & Neurodegenerative Diseases
San Antonio, Texas 78229
Contact:
Mitzi Gonzales, PhD
210-450-9047
gonzalesm20@uthscsa.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center at San Antonio

Study Contact

Mitzi Gonzales, Phd
210-450-9047
gonzalesm20@uthscsa.edu

Detailed Description

The study will consist of a screening/baseline period of up to 90 days pre-study drug, with a 12-month (+3 day) treatment period with rapamycin, followed by a post-treatment assessment completed within 14 days of the final study drug dose, and a final assessment conducted 6-months (+14 days) after the final study drug dose. The study duration is not expected to exceed 90 weeks for participants.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.