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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up year 1

Awards & highlights

STAND Trial 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.Check my eligibility

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.See study design

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.

STAND Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Attrition rate

Count of Adverse Events

Secondary outcome measures

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

Hyperkalemia

Diabetes related

Infection

Chest pain/discomfort

Breast tenderness/Gynecomastia

Surgical

100%

80%

60%

40%

20%

Study treatment Arm

Spironolactone

Placebo

STAND 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor

1,638 Previous Clinical Trials

2,560,502 Total Patients Enrolled

Alzheimer's AssociationOTHER

90 Previous Clinical Trials

40,743 Total Patients Enrolled

Antoine Trammell, MD, MPHPrincipal InvestigatorEmory University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current upper limit for participants enrolled in this experiment?

"Affirmative. According to clinicaltrials.gov, this research trial is presently accepting candidates; it was initially posted on September 6th 2022 and the most recent update occurred on September 7th 2022. This study requires 30 participants from one medical centre."

Answered by AI

What primary goal is this medical experiment attempting to accomplish?

"The primary measure of this trial, which will be taken during the Year 1 time period is Adverse Event Count. Secondary endpoints are Change in NIH Toolbox Cognitive Battery-Cognitive Function Composite Score (a score below 10 represents decreased cognitive function), Change in Hopkins Verbal Learning Test-Revised (HVLT-R) Delayed Recall Score (where higher values indicate better delayed recall), and Change in Trail Making Test Part A Score (times greater than 78 seconds indicating cognitive impairment)."

Answered by AI

How hazardous is the administration of Spironolactone to individuals?

"Data from Phase 4 trials demonstrate the efficacy and safety of Spironolactone, so it earned a score of 3."

Answered by AI

Is there still an opportunity for individuals to enroll in this clinical experiment?

"As per clinicaltrials.gov, this trial is still open to recruitment - the listing was first uploaded on September 6th 2022 and underwent a revision one day later."

Answered by AI

What prior experiments have been conducted with Spironolactone?

"Currently, 28 clinical trials are underway that investigate the effects of Spironolactone. 7 of these live experiments have reached Phase 3 while 293 sites across America offer this medication to patients. Notably, many studies related to Spironolactone's efficacy take place in Boston, Massachusetts."

Answered by AI

What health issues is Spironolactone commonly utilized to treat?

"Spironolactone is the recommended course of treatment for primary hyperaldosteronism, however it may also aid in treating cirrhosis of the liver, therapeutic procedures, and acne-ridden skin."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Spironolactone Safety in African Americans With Mild Cognitive Impairment and Early Alzheimer's Disease

Antoine Trammell 2022. "Spironolactone Safety in African Americans With Mild Cognitive Impairment and Early Alzheimer's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04522739.

All > Alzheimer Disease > Mild Cognitive Impairment