RightFit
RecruitingPhase 2

Bumetanide in Patients With Alzheimer's Disease

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of bumetanide, a water pill taken by mouth, in people whose Alzheimer's disease is confirmed by tests. It is for people with mild thinking and memory problems or mild dementia due to Alzheimer's. The study also looks at how the drug affects symptoms and signs of the disease measured by tests.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have mild thinking and memory problems or mild dementia due to Alzheimer's disease.
  • Plan to keep Alzheimer's medicines the same throughout the study.
  • Be willing and able to complete all study steps, including memory and thinking tests and MRI scans.

Who can't join

  • Have important health problems shown by screening lab tests.
  • Have long-term liver disease.
  • Have kidneys that do not work well enough.
  • Have high blood pressure that is not well controlled.
  • Take lithium, probenecid, indomethacin, or medicines that may harm hearing or the kidneys.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 sites (1)

CA