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Diuretic

Bumetanide for Alzheimer's Disease (BumxAD Trial)

Phase 2

Recruiting

Led By Kyan Younes, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Mild cognitive impairment or mild dementia due to Alzheimer's disease

Alzheimer's disease medications are planned to remain stable throughout

Must not have

Poorly managed hypertension

Chronic liver disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Summary

This trial is studying if bumetanide, a diuretic, can be used to treat Alzheimer's disease. It will also assess its safety and the clinical and biomarker effects on those with mild cognitive impairment or mild dementia.

Who is the study for?

This trial is for adults with mild cognitive impairment or early-stage Alzheimer's disease who are stable on their current Alzheimer's medications. They must be able to complete tests and an MRI. People can't join if they have significant lab test abnormalities, chronic liver disease, kidney issues, uncontrolled high blood pressure, or take certain drugs like lithium.

What is being tested?

The study is testing bumetanide—a diuretic approved for edema and hypertension—to see if it's safe and tolerable for Alzheimer's patients. It also looks at whether bumetanide affects symptoms or biomarkers of the disease compared to a placebo (a substance with no therapeutic effect).

What are the potential side effects?

Bumetanide may cause dehydration due to increased urination, electrolyte imbalances (like low potassium), dizziness, potential hearing damage (ototoxicity), and could worsen kidney function in those already at risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have mild memory loss or mild dementia because of Alzheimer's.

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My Alzheimer's medications will not change during the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My high blood pressure is not well-controlled.

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I have a long-term liver condition.

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I am not taking lithium, ototoxic, nephrotoxic drugs, probenecid, or indomethacin.

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My kidneys do not work well.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Treatment-Related Adverse Events

Secondary study objectives

Change from baseline in The Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog13)

Changed from baseline in the clinical dementia rating scale sum of boxes (CDR-SoB)

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: Bumetanide low doseActive Control1 Intervention

15 participants will take bumetanide low dose orally for 6 months and will be evaluated on cognitive and functional tests. Participants blood samples will be tested for levels of proteins involved in Alzheimer's disease.

Group II: Bumetanide high doseActive Control1 Intervention

15 participants will take bumetanide high dose orally for 6 months and will be evaluated on cognitive and functional tests. Participants blood samples will be tested for levels of proteins involved in Alzheimer's disease.

Group III: PlaceboPlacebo Group1 Intervention

10 participants will take placebo orally for 6 months and will be evaluated on cognitive and functional tests. Participants blood samples will be tested for levels of proteins involved in Alzheimer's disease.

0 / 6Eligibility criteria met