Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Tolerability of Bumetanide in Patients With Alzheimer's Disease.
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 85
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
Stanford University
RECRUITING
Stanford
Contact Information
Primary
Mina L Kim
minakim@stanford.edu
(650) 387-1559
Time Frame
Start Date: 2023-04-10
Estimated Completion Date: 2025-04-15
Participants
Target number of participants: 40
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Stanford University