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Corticosteroid

Spironolactone for Alzheimer's Disease (STAND Trial)

Phase 4
Recruiting
Led By Antoine Trammell, MD, MPH
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Renal disease, hyperkalemia, other neurological or psychiatric conditions that could impact cognition, abnormal thyroid stimulating hormone (TSH) or vitamin B12 levels, uncontrolled congestive heart failure
Uncontrolled hypertension with specific criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up year 1
Awards & highlights

Summary

This trial will study whether spironolactone is safe for older African Americans with mild cognitive impairment and whether the medication has any effect on memory or thinking skills.

Who is the study for?
This trial is for older African American adults with mild cognitive impairment or early Alzheimer's. Participants must be willing to follow the study procedures for a year, have certain blood pressure levels, and score within specific ranges on memory and thinking tests. It excludes those with severe medical issues, women who can become pregnant, recent stroke survivors, uncontrolled hypertension or heart failure.
What is being tested?
The trial is testing if spironolactone, a blood pressure medication, is safe for participants and if it affects their memory and thinking skills. Over one year, they'll take either spironolactone or a placebo while attending 4-5 study visits where their cognitive abilities will be assessed.
What are the potential side effects?
Spironolactone may cause side effects like electrolyte imbalances (high potassium), kidney problems, low blood pressure symptoms (dizziness), breast enlargement in men (gynecomastia), menstrual irregularities in women.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have kidney disease, high potassium, uncontrolled heart issues, or mental conditions affecting my thinking. My thyroid and vitamin B12 levels are normal.
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My blood pressure is not well controlled.
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I have difficulty understanding or following instructions.
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I am a woman who can become pregnant.
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I have had a stroke within the last three years.
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I cannot give consent due to cognitive issues and have no one to help.
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I am unable to complete cognitive tests required for the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~year 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and year 1 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Attrition rate
Count of Adverse Events
Secondary study objectives
Change in Digit Span Test Score
Change in Hopkins Verbal Learning Test-Revised (HVLT-R) Delayed Recall Score
Change in Hopkins Verbal Learning Test-Revised (HVLT-R) Recognition Discrimination Index Score
+3 more

Side effects data

From 2022 Phase 4 trial • 79 Patients • NCT02169089
8%
Hypotension
5%
Infection
5%
Hyperkalemia
5%
Diabetes related
3%
Surgical
3%
Chest pain/discomfort
3%
Breast tenderness/Gynecomastia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Spironolactone
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SpironolactoneExperimental Treatment1 Intervention
Participants with mild cognitive impairment or early Alzheimer's Disease who are randomized to receive spironolactone for 12 months.
Group II: PlaceboPlacebo Group1 Intervention
Participants with mild cognitive impairment or early Alzheimer's Disease who are randomized to receive a placebo to match spironolactone for 12 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spironolactone
2005
Completed Phase 4
~7340

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,679 Previous Clinical Trials
2,583,636 Total Patients Enrolled
Alzheimer's AssociationOTHER
95 Previous Clinical Trials
42,270 Total Patients Enrolled
Antoine Trammell, MD, MPHPrincipal InvestigatorEmory University
~9 spots leftby Sep 2025
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