Could a common drug protect the brain from Alzheimer's?
NCT ID NCT05386914
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early study tests whether sirolimus, an FDA-approved drug, can improve blood flow to the brain in healthy adults with a genetic risk for Alzheimer's disease. Researchers will use MRI scans to measure changes after 4 weeks of daily low-dose sirolimus. The study also explores how lung function relates to brain blood flow. It involves 205 cognitively normal adults aged 45-65.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sirolimus
- What this could lead to
- If it works, this could point toward a way to improve brain blood flow in people at risk for Alzheimer's disease.
- What could go wrong
- This is a very early Phase 1 study with only 4 weeks of treatment. It is not designed to test whether sirolimus prevents or treats Alzheimer's, only whether it changes blood flow.
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 205 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Mar 2023
- Expected to finish
-
Dec 2027
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
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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.
This study consisted of two separate study parts conducted under the same IRB approval. Part I and Part II were operationally distinct but administratively linked. Part I: Inclusion Criteria: * 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 Criteria: * 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) * 17.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: Exclusion Criteria: 1. Baseline oxygen requirement 2. Blood oxygen saturation of 90% or less than as measured by pulse oximetry on the day of imaging 3. FEV1 percent predicted less than 25% 4. Claustrophobia, inner ear implants, aneurysm or other surgical clips, metal foreign bodies in the eye, pacemaker or other contraindication to MR scanning. Subjects with any implanted device that cannot be verified as MRI compliant will be excluded 5. Chest circumference greater than that of the xenon-129 MR coil. The circumference of the coil is approximately 42 inches 6. History of congenital cardiac disease or history of apneic episodes 7. Inability to understand simple instructions or to hold still for approximately 10 seconds 8. History of respiratory infection within 2 weeks prior to the MR scan
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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.
Contacts and locations
Locations
-
University of Missouri-Columbia
Columbia, Missouri, 65212, United States
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