REACH Clinical Trial

The trial will evaluate the use of Rapamycin to slow progression of amnestic mild cognitive impairment and early-stage Alzheimer’s. It will also collect vital information on Alzheimer’s markers and relevant outcomes for future clinical trials.

Effectiveness of Rapamycin

Rapamycin is a FDA approved immune modulator. In research studies, it has shown to restore cerebrovascular function and alter the cellular and biological processes underlying the development of Alzheimer’s.

Eligibility

Qualifications to participate include, but are not limited to:

• • Adults ages 55 to 89 years
  • Diagnosis of mild cognitive impairment or Alzheimer’s
  • A legally authorized representative to sign informed consent and to attend all trial visits

*Participants may continue Alzheimer’s medications like Donepezil, Rivastigmine, Memantine, Galantamine, if they have been on a stable dose for at least 3 months.

Non-eligibility

Disqualifications to participate include, but are not limited to:

• Diagnosis of diabetes
• Current tobacco use
• Use of anti-platelet or anti-coagulant medications other than aspirin
• Chronic heart failure
• Organ transplant recipient
• History of skin ulcers or poor wound healing
• Immunosuppressant therapy within the last year
• Chemotherapy or radiation treatment within the last year
• Current or chronic history of liver disease or known hepatic or biliary abnormalities
• Untreated hypertriglyceridemia
• Current or chronic history of pulmonary disease or abnormal pulse oximetry
• Pregnancy or lactation
• History of myocardial infarction, active coronary artery disease, intestinal disorders, stroke or transient ischemic attack within the past 6 months
• Significant neurological conditions other than mild cognitive impairment or Alzheimer’s
• 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

Process

The trial will begin with 2 screening appointments for eligibility. Selected participants will be randomly assigned to receive 1 mg of Rapamycin or placebo daily for 12 months. The first 6 months of the trial will include monthly visits at home or at our study site. For the last 6 months of the trial, visits will be held every 3 months.
Visits will be used to observe changes from baseline in cognition, physical functioning and functional status.

Visits may include:

• Amyloid PET scan
• Cognitive exam
• Physical exam
• Brain MRI
• Lumbar puncture
• Blood lab