Start: August 11, 2021
End: August 2024
What Is This Study About?
This Phase 2 study will evaluate the safety and effects of rapamycin, an FDA-approved anti-fungal medication, in older adults with mild cognitive impairment (MCI) or early-stage Alzheimer's. Participants will be randomly assigned to receive either rapamycin or a placebo, by mouth, daily for one year. Researchers will monitor participants for any side effects throughout the study. They will also assess changes in cognitive and daily functioning and changes in brain structure and metabolism using MRI and PET brain scans and evaluate the drugs metabolism with lumbar puncture and other lab tests, before and after treatment and in a six-month follow-up assessment.
Do I Qualify To Participate in This Study?
- Diagnosis of MCI or Alzheimer's with:
- Mini-Mental State Examination of 18 to 30
- Clinical Dementia Rating of 0.5 to 1
- Presence of amyloid plaques, based on a PET brain scan
- Laboratory tests results within normal range
- Reliable study partner who is available to accompany the participant to all study visits and, if necessary, can provide informed consent as a legally authorized representative
- If taking any Alzheimer's medications (e.g., donepezil, rivastigmine, memantine, galantamine), the dosage must be stable for at least three months before starting the study
Must NOT have:
- Significant neurological condition other than MCI or Alzheimer's
- History of a significant health condition, including:
- Skin ulcers or poor wound healing
- Liver or kidney disease
- Untreated hypertriglyceridemia (fasting triglycerides < 250 mg/dl)
- Chronic heart failure, heart disease, or abnormal blood oxygen level (< 90%)
- Active inflammatory, autoimmune, infectious (e.g., COVID-19), liver, gastrointestinal, and/or severe mental illness
- Malignant cancer
- Heart attack, stroke, transient ischemic attack, or active coronary artery disease in the past six months
- Chemotherapy, radiation treatment, or immunosuppressant therapy within the last year
- Poorly controlled high blood pressure, based on two readings during study screening
- History of brain mass or condition causing abnormal intracranial pressure, or any other condition that could make having a lumbar puncture unsafe
- Pregnancy or lactation
- Current use of tobacco or illicit drugs, alcohol abuse, or use of prohibited medications, including:
- Blood thinners other than aspirin
- Any medication that affects cytochrome P450 3A4
If I Qualify, Who Do I Contact?
Contact study personnel listed either under the general study contact or the location nearest you.
Mitzi Gonzales, Phd
Floyd A Jones
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.
Where Is This Study Located?
Lead: The University of Texas Health Science Center at San Antonio
Source: ClinicalTrials.gov ID: NCT04629495