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Could a common drug shield the brain from Alzheimer's?

NCT ID NCT07728175

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 27, 2026 · Last updated Jul 31, 2026 · Updated 4 times

Summary

This phase 1 trial tests whether sirolimus (rapamycin), an FDA-approved medication, can improve blood flow and energy use in the brains of women aged 45 to 65 who carry the ApoE4 gene — a gene that raises the risk of developing Alzheimer's disease. Participants are randomly assigned to take either sirolimus or a placebo daily for four weeks. The study uses MRI scans and blood tests to measure changes in brain blood flow and related markers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sirolimus (rapamycin), an FDA-approved medication that may improve blood flow to the brain
What this could lead to
If it works, this could point toward a way to delay or prevent Alzheimer's disease in people with the ApoE4 gene.
What could go wrong
This is an early phase 1 trial with a small number of participants and a short 4-week treatment period. It tests only a biomarker (blood flow), not whether Alzheimer's is actually prevented. Sirolimus can have side effects like mouth sores, infections, and metabolic changes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 225 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

45 to 65 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

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Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • University of Missouri

    Columbia, Missouri, 65212, United States

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