Sirolimus for Women with ApoE4 Gene and Alzheimer's Risk

This study is looking at whether a medication called sirolimus (also known as rapamycin) can improve blood flow and energy use in the brain. It's for women aged 45 to 65 who have the ApoE4 gene, which increases the risk of developing Alzheimer's disease. Alzheimer's is a brain disease with no cure, characterized by harmful clumps and fibers. Participants will receive either sirolimus or a placebo (a pill with no medicine). Researchers will measure changes in brain blood flow using an MRI after 4 weeks to see if sirolimus is helpful. The study plans to enroll 225 women, but its current status is unclear.

Study design
This interventional study plans to enroll 225 participants. It has two groups: one receiving sirolimus and one receiving a placebo.
What's involved
Participants will receive either sirolimus or a placebo. Changes in brain blood flow will be measured by MRI at baseline and again at 4 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, change in cerebral blood flow, is measured from baseline to 4 weeks.

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NCT07728175

Effects of Sirolimus on Asymptomatic ApoE4 Carriers

Not Yet Recruiting
PHASE1Ages 45–65InterventionalBasic science
University of Missouri-Columbia
~225 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:Sirolimus (rapamycin)Placebo

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Cerebral Blood Flow as measured by MRI
Measured over Baseline to 4 weeks
Genetic Predisposition to Disease
Healthy Volunteer
APOE-4 Positive
1 sites across 1 states
Missouri1
  • Ai-Ling Lin, PhD · PRINCIPAL_INVESTIGATOR · University of Missouri-Columbia

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Eligibility criteria

Inclusion

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

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
  • Change in Cerebral Blood Flow as measured by MRIBaseline to 4 weeks

    Rate of blood perfusion expressed as mL/100g/min globally and regionally