NCT04522739

Spironolactone Safety in African Americans With Mild Cognitive Impairment and Early Dementia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate whether a blood pressure medication, spironolactone, can be tolerated by older African American adults that have memory and thinking problems, also called mild cognitive impairment (MCI). This study will also investigate the effect of spironolactone on memory and thinking abilities as measured by performance on cognitive tests, which are tests that measure memory and thinking skills. Participants will take spironolactone or a placebo for one year and will have 4 to 5 study visits during the study period.

Detailed description

In 2018, 5.5 million older adults in the United States were diagnosed with Alzheimer's disease, and it is predicted that 15 million people will be diagnosed with dementia, including Alzheimer's disease by 2060. Older African Americans adults are more likely to be diagnosed with Alzheimer's disease as compared to Whites. Research search studies on high blood pressure show that African Americans have higher levels of the hormone aldosterone that can be involved with regulation of blood pressure and blood vessels. Research studies also show that changes in blood vessels in the brain from higher aldosterone levels are related to changes in thinking skills and memory (cognition). Spironolactone is a drug that blocks aldosterone and has been used to treat high blood pressure for 60 years. More recently, this drug has shown to have the potential to decrease declines in thinking skills and memory. Spironolactone is widely used in clinical practice and is well-tolerated by younger and older persons. As such, this study is designed to learn how a small group of older African American adults with mild cognitive impairment will tolerate the drug. Persons who are eligible for the study and agree to participate will receive spironolactone or a placebo and be monitored for drug side effects for one year. During the study, the researchers will monitor changes in thinking and memory and blood vessel stiffness, in addition to side effects that may be related to the drug. Study tests include questionnaires that evaluate thinking skills and memory, and an ultrasound that measures the stiffness of blood vessels in the neck which deliver blood to the brain. The thinking and memory tests and ultrasound will be performed at the beginning of the study, then repeated at the end of the study. The results of this study can justify a larger size study of spironolactone in older African Americans with mild cognitive impairment. The study has the potential to identify a new use for a well-known drug that is safe and widely used in current clinical practice. Further, the results from this study can address a racial difference in Alzheimer's disease and preserve the health of the brain as people age.

Conditions

• Mild Cognitive Impairment
• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	Spironolactone	Study participants will receive a 25 mg dose of spironolactone. Participants will take one capsule by mouth per day for 12 months.
DRUG	Placebo	A placebo to match spironolactone will be taken orally once per day for 12 months.

Timeline

• Start date: 2022-09-06
• Primary completion: 2025-09-23
• Completion: 2025-09-23
• First posted: 2020-08-21
• Last updated: 2025-10-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study