Effects of Sirolimus on Asymptomatic ApoE4 Carriers

Part of paid clinical trials in Columbia, Missouri.

Sponsor
University of Missouri-Columbia
Study ID
NCT07728175
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • APOE-4 Positive
  • Genetic Predisposition to Disease
  • Healthy Volunteer

Eligibility Criteria

Sex
FEMALE
Age
45 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Sirolimus (rapamycin) — DRUG
    Participants in Sirolimus arm will receive Sirolimus.
  • Placebo — DRUG
    Participants in the Placebo arm will receive Placebo

Study Details

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 is currently no cure. Sirolimus (Rapamycin) is an FDA-approved medication which may improve the blood flow to the brain. The purpose of the clinical trial is to find out whether sirolimus can help improve blood flow and energy use in the brain in women ages 45 to 65 who have the ApoE4 gene, a gene which increases the risk of developing Alzheimer's disease later in life. There will be two arms in this trail, a sirolimus arm and a placebo arm. A placebo is a pill that looks like the study drug, but it does not have any real medicine in it. Participants will be randomized to one arm or the other, but not to both arms. Three study visits over a 12-week period are required. Participants will: (i) Complete some questionnaires about how well you think; (ii) Complete genetic testing for the ApoE4 gene; (iii) Have blood work, blood pressure and height and weight collected; (iv) Take either Sirolimus or a placebo daily, by mouth, for approximately 4 weeks; (v) Keep a diary of when the sirolimus or placebo is taken; (vi) Complete 2 Magnetic Resonance Imaging (MRI) exams

Key Dates

First listed
Jul 27, 2026
Start date
Dec 1, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2027
Completion
Jul 7, 2028

Study Design

Enrollment
225 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: Sirolimus
  • Placebo Comparator: Placebo

Primary Outcome Measure

Change in Cerebral Blood Flow as measured by MRI [ Time Frame: Baseline to 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MissouriColumbiaMissouri65212
Kim Ray
[email protected]
573-884-5372
Nathan Bresette
[email protected]
Ai-Ling Lin, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Missouri· Columbia, MO

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