RecruitingRecruiting
Bumetanide in Patients With Alzheimer's Disease
NCT06052163 · Stanford University
In plain English
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Official 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.
About this study
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.
Study design
Enrollment target: 40 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2023-04-10
Estimated completion: 2026-12-15
Last updated: 2026-01-14
Interventions
Drug: BumetanideDrug: Placebo
Primary outcomes
- • Incidence of Treatment-Related Adverse Events (6 months)
Sponsor
Stanford University · other
Contacts & investigators
ContactMina L Kim · contact · minakim@stanford.edu · (650) 387-1559
InvestigatorKyan Younes, MD · principal_investigator, Stanford University
All locations (1)
Stanford UniversityRecruiting
Stanford, California, United States