Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06052163

Bumetanide in Patients With Alzheimer's Disease

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Stanford University

Stanford, California, 94305, United States

Location status: Recruiting

Location contact

Kyan Younes, MD

PRINCIPAL_INVESTIGATOR

Mina L Kim

CONTACT

[email protected]

(650)387-1559

Stanford Memory Disorders research

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bumetanide

Drug

Bumetanide is an FDA approved loop diuretic that has been used for more than three decades to treat edema, congestive heart failure, and hypertension across the life span. It has a well-known side effect profile. Most importantly it can cause dehydration and electrolyte imbalance especially at higher doses. This medication is given to individuals at the similar age group as Alzheimer's disease patients and Alzheimer's disease or cognitive impairment do not preclude its use in patients who need it for its FDA indications. At low doses and when titrated carefully, the medication is well tolerated. However, it has not been studied specifically in Alzheimer's disease patients.

Other names: Bumex

Placebo

Drug

A placebo has no active properties and is taken orally.

Primary outcomes

  1. Incidence of Treatment-Related Adverse Events

    Time frame: 6 months

    Number of participants with adverse events including clinical signs and symptoms, change in vital signs, ECGs, laboratory safety tests, and suicidality assessments.

Secondary outcomes

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

    Time frame: 6 months

    The ADAS-Cog evaluates cognition and is scored from 0 to 90 points with a score of 0 indicating no impairment, and a score of 90 indicating maximum impairment

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

    Time frame: 6 months

    CDR-SoB evaluates function with total possible score of 0 to 18 with higher scores indicating more impairment

Study contacts

Contact information is provided by the study sponsor or research team.

Mina L Kim

CONTACT

[email protected]

(650) 387-1559

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Tolerability of Bumetanide in Patients With Alzheimer's Disease.

Acronym: BumxAD

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 25, 2023
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.