Status:
RECRUITING
Short Term Sirolimus Treatment and MRI of the Brain and Lungs
Lead Sponsor:
University of Missouri-Columbia
Conditions:
Genetic Predisposition to Disease
Healthy Volunteers
Eligibility:
All Genders
45-65 years
Phase:
PHASE1
Brief Summary
Alzheimer's disease is a devastating neurodegenerative disease characterized by accumulation of clumps (also called plaques) and bundles of fibers (also called tangles) in the brain, for which there i...
Eligibility Criteria
Inclusion
- Part I:
- 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
- 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)
- 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
- Part II:
- The inclusion and exclusion criteria for Part I apply to Part II with the addition of the following:
Key Trial Info
Start Date :
March 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
205 Patients enrolled
Trial Details
Trial ID
NCT05386914
Start Date
March 2 2023
End Date
December 1 2027
Last Update
August 5 2025
Active Locations (1)
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1
University of Missouri-Columbia
Columbia, Missouri, United States, 65212