Clinical Trial

Seeking Healthy Adults Age 45-65 to Participate in a Study of a Potential Future Treatment for People at Risk for Alzheimer’s Disease

The Department of Radiology at the University of Missouri is conducting a research study to investigate whether sirolimus, an FDA-approved drug, can improve blood flow to the brain. Previous research has suggested that individuals with Alzheimer’s disease have reduced blood flow to the brain, and we want to explore whether sirolimus can help to increase blood flow and potentially reduce the risk or severity of Alzheimer’s in the future. Healthy adults aged 45-65 are invited to participate in the study, which will last for 12 weeks and consist of six visits. During these visits, participants will undergo medical evaluations, including Magnetic Resonance (MR) brain imaging, and blood, saliva and at-home stool sample collections. For four weeks, participants will be required to take one sirolimus pill daily. All study-related procedures and medications will be provided at no cost to the participant. Compensation for time (up to $1,200) will be provided for completing the study. The results of this trial have the potential to significantly advance the understanding and treatment of Alzheimer’s disease and could lead to the development of new therapies. Further information can be found at ClinicalTrials.gov.

If you are interested in participating, please contact us at 573-884-5372 or radresearch@health.missouri.edu. IRB #2091042 Principal Investigator: Ai-Ling, Lin, PhD.

Criteria

Inclusion Criteria:

1. Age 45-65 y/o
2. Male or female, all ethnic groups
3. Montreal Cognitive Assessment (MoCA) score greater than or equal to 26
4. Clinical Dementia Rating (CDR) Staging Instrument = 0
5. Carrier Cohort: APOE4 homozygous or heterozygous
6. Non-Carrier cohort: no APOE4 gene identified

Exclusion Criteria:

1. Diagnosis of mild cognitive impairment (MCI) or dementia, including Alzheimer’s disease
2. BMI ≥35 (based on MRI feasibility)
3. Diabetes (HBA1c≥6.5% or antidiabetic medications)
4. History of skin ulcers or poor wound healing
5. Current tobacco or illicit drug use or alcohol abuse (defined as ≥4 per day or ≥14 per week for men and ≥3 per day or ≥7 per week for women) (Per NIAAA guidelines)
6. Use of anti-platelet or anti-coagulant medications other than aspirin
7. Current medications that affect cytochrome P450 3A4 (CYP3A4)
8. Immunosuppressant therapy within the last year
9. Chemotherapy or radiation treatment within the last year
10. Current or chronic history of liver or kidney disease or known hepatic or biliary abnormalities
11. Untreated hypertriglyceridemia (fasting triglycerides < 300 mg/dl)
12. Current or chronic significant history of pulmonary disease
13. Chronic heart failure
14. Pregnancy or lactation
15. Recent history (past six months) of myocardial infarction, active coronary artery disease, intestinal disorders, stroke, or transient ischemic attack
16. Poorly controlled blood pressure (systolic BP>160 or diastolic BP>100 mmHg)
17.Active inflammatory, Coronavirus (COVID-19), autoimmune, infectious, hepatic, gastrointestinal, malignant, and/or severe mental illness
18. History of, or MRI, or CT positive for, any space occupying brain lesion, including mass effect or abnormal intracranial pressure
19. Organ transplant recipients
20. History of Stroke
21. History of ruptured intracranial aneurysm
22. Any condition for which a MRI procedure is contraindicated. Some examples include: metallic material in the body, such as pacemakers, metallic clips, etc.
23. Likelihood of claustrophobia

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