Bumetanide in Patients With Alzheimer's Disease
- Registration Number
- NCT06052163
- Lead Sponsor
- Stanford University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo 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. Bumetanide low dose Bumetanide 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. Bumetanide high dose Bumetanide 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.
- Primary Outcome Measures
Name Time Method Incidence of Treatment-Related Adverse Events 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 Outcome Measures
Name Time Method Changed from baseline in the clinical dementia rating scale sum of boxes (CDR-SoB) 6 months CDR-SoB evaluates function with total possible score of 0 to 18 with higher scores indicating more impairment
Change from baseline in The Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog13) 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
Trial Locations
- Locations (1)
Stanford University
🇺🇸Stanford, California, United States