Sirolimus for ApoE4 Carriers: Testing Brain Blood Flow in Women 45-65

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 interventional study enrolling ApoE4-positive women aged 45 to 65 to see if sirolimus can influence brain perfusion and energy use. Participants are randomized to receive either sirolimus or a placebo for 12 weeks across three visits. The study includes questionnaires, genetic confirmation of ApoE4 status, and standard safety monitoring. Outcomes focus on safety and changes in brain blood flow measured by imaging, with auxiliary assessments of cognitive function and daily living activities. The trial is conducted at the University of Missouri-Columbia with a lead sponsor and no listed collaborators.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Willing and able to provide informed consent
2. Sex assigned at birth: female
3. 45-65 years old
4. Able to perform self-care and activities of daily living with no or minimal assistance
5. Post-menopausal status or use of highly effective contraception. Post-menopausal is defined as either

   * 12 months of spontaneous amenorrhea with an appropriate clinical profile (e.g., age-appropriate, history of vasomotor symptoms)
   * surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks prior to screening. For oophorectomy alone, post-menopausal status must be confirmed by follow-up hormone level assessment
   * Highly effective contraception includes intrauterine devices (IUD), oral contraceptives, or other hormonal contraceptives including injectables, transdermal patches, implants or vaginal rings, or refraining from heterosexual intercourse during the 4 weeks of taking the study drug and for 2 weeks after no longer taking the study drug
6. Body weight of ≥ 40 kg
7. Ability to effectively communicate with the investigator and comply with study requirements

Exclusion Criteria:

1. Diagnosis of mild cognitive impairment (MCI), dementia, or Alzheimer's disease
2. BMI ≥ 35 (based on MRI feasibility)
3. Type 1 diabetes or poorly controlled type 2 diabetes (HbA1c ≥ 6.5%)
4. History of skin ulcers or poor wound healing
5. Current tobacco or illicit drug use or alcohol abuse (defined as ≥ 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. Required use of medications that affect cytochrome P450 3A4 (CYP3A4) or alter cerebral blood flow (see Appendix 1 for tables of excluded medications)
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, 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. History of malignancy within the past 2 years, with the following exceptions:

    * Localized basal cell or squamous cell carcinoma of the skin
    * Prostate cancer confined to the gland (AJCC stage T2N0M0 or better)
    * Cervical carcinoma in situ
    * Breast cancer localized to the breast
23. History of epilepsy

Where it's running

• University of Missouri
  Columbia, Missouri, United States Recruiting

Study contacts

• Principal investigator: Ai-Ling Lin, PhD — University of Missouri-Columbia
• Study coordinator: Kim Ray
• Email: umhsradstudycoordinators@health.missouri.edu
• Phone: 573-884-5372

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.