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Corticosteroid

Spironolactone for Alzheimer's Disease (STAND Trial)

Phase 4

Waitlist Available

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

Pivotal Trial

Drug Has Already Been Approved

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ year 1

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

Hypotension

Infection

Hyperkalemia

Diabetes related

Surgical

Chest pain/discomfort

Breast tenderness/Gynecomastia

100%

80%

60%

40%

20%

Study treatment Arm

Spironolactone

Placebo

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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

~14580

0 / 7Eligibility criteria met