Active — Not RecruitingPhase 2

Rapamycin - Effects on Alzheimer's and Cognitive Health

United States40 participantsStarted 2021-08-11

Plain-language 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).

Who can participate

Age range

55 Years – 89 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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 criteria

. Diabetes (HBA1c≥6.5% or antidiabetic medications)
. History of skin ulcers or poor wound healing

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This is a Phase 2 trial testing rapamycin, a drug not currently approved for Alzheimer's or mild cognitive impairment — what does it mean that the study is still mainly checking safety and tracking things like blood glucose and albumin levels, rather than confirming whether it actually improves memory or slows cognitive decline?
2The trial is actively monitoring changes in blood chemistry, including calcium, carbon dioxide, and glucose — are any of my current health conditions or medications likely to make those kinds of side effects more risky for me specifically?
3Since the trial is no longer enrolling new participants, does that mean there are any published or preliminary results we could look at together to understand what the early safety data is showing so far?
4Rapamycin is an immunosuppressant drug originally used to prevent organ rejection — given that, how would you weigh the risks of suppressing my immune system against whatever potential benefit might exist at this early stage of research?
5Before considering an experimental option like this, are there standard-of-care treatments or other clinical trials for mild cognitive impairment or early Alzheimer's that you think would be a more established starting point for my situation?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.