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Bumetanide in Patients With Alzheimer's Disease (BumxAD)

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ClinicalTrials.gov Identifier: NCT06052163
Recruitment Status : Recruiting
First Posted : September 25, 2023
Last Update Posted : April 12, 2024
Sponsor:
Information provided by (Responsible Party):
Kyan Younes, Stanford University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: Bumetanide Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
  1. Bumetanide low dose, 15 participants
  2. Bumetanide high dose, 15 participants
  3. Placebo, 10 participants
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Actual Study Start Date : April 10, 2023
Estimated Primary Completion Date : April 15, 2025
Estimated Study Completion Date : April 15, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Bumetanide

Arms and Interventions
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Arm Intervention/treatment
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.

 Drug: 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.
Other Name: Bumex
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.

 Drug: 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.
Other Name: Bumex
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.

 Drug: Placebo
A placebo has no active properties and is taken orally.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06052163


Contacts
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Contact: Mina L Kim (650) 387-1559 minakim@stanford.edu

Locations
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United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Mina L Kim    650-387-1559    mina.kmiecik@stanford.edu   
Contact: Stanford Memory Disorders research       memoryresearch@stanford.edu   
Principal Investigator: Kyan Younes, MD         
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Kyan Younes, MD Stanford University
More Information
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Additional Information:

Publications:

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Responsible Party: Kyan Younes, Clinical Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT06052163    
Other Study ID Numbers: IRB-69153
First Posted: September 25, 2023    Key Record Dates
Last Update Posted: April 12, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
 Mental Disorders
Bumetanide
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action