Recruiting
Phase 2

Bumetanide

Sponsor:

Stanford University

Code:

NCT06052163

Conditions

Alzheimer Disease

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Bumetanide

Placebo

Study Details

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.

Conditions

Alzheimer Disease

Study ID

NCT06052163

Start date

Apr 10, 2023

Status verified date

Jan, 2026

Completion date

Dec 15, 2026

Anticipated

Primary completion date

Dec 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Bumetanide low dose

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.

active comparator: Bumetanide high dose

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.

placebo comparator: Placebo

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.

Interventions

Bumetanide

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.

Placebo

A placebo has no active properties and is taken orally.

Primary outcome measure

  • Incidence of Treatment-Related Adverse Events [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Mina L Kim

(650) 387-1559minakim@stanford.edu

Locations

Stanford University

Recruiting

Stanford, California, United States, 94305

Contacts

Mina L Kim

(650)387-1559mina.kmiecik@stanford.edu

Stanford Memory Disorders research

memoryresearch@stanford.edu

Principal Investigator:

Kyan Younes, MD

More Information

Sponsor

Stanford University

Last update posted

Jan 14, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-01-14.