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

NCT04522739 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-10-29

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Antoine Trammell, MD, MPH · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-06
Primary Completion
2025-09-23
Completion
2025-09-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04522739 on ClinicalTrials.gov