Effects of rapamycin on Alzheimer's and cognitive health

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

This study is testing if a medication called rapamycin can help improve thinking and memory in older adults with early-stage Alzheimer's disease and mild cognitive impairment.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 55 Years to 89 Years
• Sex: All
• Sponsor: The University of Texas Health Science Center at San Antonio (other)
• Drugs / interventions: Chemotherapy, radiation
• Locations: 1 site (San Antonio, Texas)
• Trial ID: NCT04629495 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, and feasibility of a 12-month oral rapamycin treatment in older adults diagnosed with amnestic mild cognitive impairment (aMCI) and early-stage Alzheimer's disease (AD). Participants will undergo a screening period of up to 90 days, followed by the treatment phase and subsequent assessments to monitor cognitive changes and safety. The study aims to determine if rapamycin can positively impact cognitive health in this population.

Who should consider this trial

Good fit: Ideal candidates are older adults aged 55 to 89 with a diagnosis of mild cognitive impairment or early-stage Alzheimer's disease who are amyloid positive.

Not a fit: Patients with advanced Alzheimer's disease or those not meeting the specific cognitive and health criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve cognitive function and slow the progression of Alzheimer's disease in affected individuals.

How similar studies have performed: While there is ongoing research into the effects of rapamycin on neurodegenerative diseases, this specific approach in Alzheimer's treatment is novel and has not been extensively tested.

Eligibility criteria

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

Where this trial is running

San Antonio, Texas

• Glenn Biggs Institute for Alzheimer's & Neurodegenerative Diseases — San Antonio, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Sudha J Seshadri, MD — The University of Texas Health Science Center at San Antonio
• Study coordinator: Sudha Seshadri, MD

Conditions: Mild Cognitive Impairment, Alzheimer Disease, Cognition, Alzheimer's disease biomarkers, Neuroimaging