NCT06052163 Bumetanide in Patients With Alzheimer's Disease
| NCT ID | NCT06052163 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Stanford University |
| Condition | Alzheimer Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-04-10 |
| Primary Completion | 2026-12-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2023-04-10 with a primary completion date of 2026-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to investigate bumetanide in patients with biologically confirmed Alzheimer's disease (AD). Bumetanide is a potent diuretic administered orally and is FDA approved for the treatment of edema and hypertension. Repurposing bumetanide as a medication for AD has been proposed based on data that demonstrated its ability to "flip" the APOE genotype-dependent transcriptomic signatures in AD mouse and cell culture models. Critically, this discovery was subsequently explored in Electronic Health Record cohorts, which revealed that among individuals over the age of 65, bumetanide exposure was significantly associated with a lower prevalence of AD in three independent datasets. Primary Objective: To evaluate the safety and tolerability of bumetanide when administered to participants with biomarker-confirmed Alzheimer's disease. Secondary Objective: To evaluate the clinical and biomarker effects of bumetanide in participants with mild cognitive impairment or mild dementia due to Alzheimer's disease.
Eligibility Criteria
Inclusion Criteria: * Mild cognitive impairment or mild dementia due to Alzheimer's disease. * Alzheimer's disease medications are planned to remain stable throughout. * Willingness and ability to complete all aspects of the study including assessments, neuropsychological testing, and MRI. Exclusion Criteria: * Clinically significant abnormalities in screening laboratory tests * Chronic liver disease * Renal insufficiency * Poorly managed hypertension * Participants taking the following concomitant medications, based on the current Prescribing Information for bumetanide: lithium, drugs with ototoxic potential, drugs with nephrotoxic potential, probenecid, and indomethacin.
Contact & Investigator
Kyan Younes, MD
PRINCIPAL INVESTIGATOR
Stanford University
Frequently Asked Questions
Who can join the NCT06052163 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 85 Years, studying Alzheimer Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06052163 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06052163 currently recruiting?
Yes, NCT06052163 is actively recruiting participants. Contact the research team at minakim@stanford.edu for enrollment information.
Where is the NCT06052163 trial being conducted?
This trial is being conducted at Stanford, United States.
Who is sponsoring the NCT06052163 clinical trial?
NCT06052163 is sponsored by Stanford University. The principal investigator is Kyan Younes, MD at Stanford University. The trial plans to enroll 40 participants.
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