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STAND

CompletedPhase 4

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

Lead sponsor

Emory University

Asset

Spironolactone

Listed sites

1

Recruiting sites

-

Enrollment

25

actual

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criterion

•MoCA 13-25

Primary endpoints

•Count of Adverse Events•Attrition rate

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04522739
Org study IDSTUDY00000124

Timeline

Milestones

Study first posted2020-08-21actual
Study start2022-09-06actual
Primary completion2025-09-23actual
Study completion2025-09-23actual
Last update posted2025-10-29actual

Assets

Drug assets

Spironolactone

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age50 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Signed and dated informed consent form
•Willingness to comply with all study procedures and availability for the duration of the study
•Self-identified African American
•Blood pressure (BP) and hypertension criteria: normotensive and hypertensive participants will be eligible
-Normotensive criteria: BP 110-140/40-90 mmHg and not receiving any treatment for hypertension
-Hypertensive criteria: only controlled hypertensives will be eligible with BP range as in the normotensive criteria of 110-140/40-90 mmHg
•MCI defined as:
-Abnormal memory function per the Logical Memory subscale (Delayed Paragraph Recall, Paragraph A only) from the Wechsler Memory Scale-Revised (the maximum score is 25):
-Score <11 for 16 or more years of education
-Score <9 for 8-15 years of education
-Score <6 for <7 years of education
-Montreal Cognitive Assessment (MoCA) score 13-25
-Preserved general functional performance per Functional Assessment Questionnaire (FAQ)<9

Exclusion criteria

•History of stroke in the previous three years
•MoCA<13 or the inability to follow instructions to perform cognitive testing
•Inability to participate in the study procedures: cognitive tests (communication limitations from language or other factors)
•Active medical problem/symptom that interferes with the study procedures, e.g., chest pain, shortness of breath, or abdominal pain
•Deemed ineligible by study investigators due to safety issues or non-compliance
•History of the inability to tolerate treatment with an aldosterone antagonist
•Hypertension
-Uncontrolled defined as a BP > 140/90 mmHg
-Current therapy with RAAS modulating medications, i.e., angiotensin II receptor blocker (ARB), angiotensin converting enzyme inhibitor (ACEi), renin inhibitor, or aldosterone antagonist such as eplerenone (Inspra) due to the risk of hyperkalemia and the interference with the renin angiotensin aldosterone system (RAAS) system
•Renal disease (baseline creatinine > 2.0 mg/dL)
•Hyperkalemia (K+ > 5.5 milliequivalent (mEq)/dL)
•Other neurological or psychiatric conditions that could impact cognition, e.g., Parkinson's disease and related movement disorders, multiple sclerosis, epilepsy, or schizophrenia, untreated major depressive disorder, and other psychotic disorders
•Abnormal thyroid stimulating hormone (TSH) (>10 milliunits (mU)/L) or vitamin B12 (<250 pg/mL) as they can impact cognitive function. If the potential participant's TSH and/or vitamin B12 levels are abnormal, then the PI may enroll that person if it is thought the lab abnormalities are unrelated and do not affect cognitive function
•Active medical or psychiatric disease, which in the judgment of the study investigators affects participant safety or the scientific integrity of the study
•Uncontrolled congestive heart failure reflected by poor exercise tolerance and shortness of breath
•Women of childbearing potential, i.e., non-menopausal
•When potential participants are not capable of providing informed consent due to their cognitive impairment and a study partner/legally authorized representative (LAR) is not available to sign consent forms on their behalf

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Memory
4
Executive function / language
2
Safety / tolerability / PK
2

Memory

4 endpoints
Secondary/protocol endpoint

Change in Hopkins Verbal Learning Test-Revised (HVLT-R) Total Recall Score

Time frame:Baseline, Month 6, Month 12

change from baseline, improvement

Secondary/protocol endpoint

Change in Hopkins Verbal Learning Test-Revised (HVLT-R) Delayed Recall Score

Time frame:Baseline, Month 6, Month 12

change from baseline, improvement

Secondary/protocol endpoint

Change in Hopkins Verbal Learning Test-Revised (HVLT-R) Recognition Discrimination Index Score

Time frame:Baseline, Month 6, Month 12

change from baseline, improvement

Secondary/protocol endpoint

Change in Digit Span Test Score

Time frame:Baseline, Month 6, Month 12

change from baseline, improvement

Executive function / language

2 endpoints
Secondary/protocol endpoint

Change in Trail Making Test Part A Score

Time frame:Baseline, Month 6, Month 12

change from baseline, improvement

Secondary/protocol endpoint

Change in Trail Making Test Part B Score

Time frame:Baseline, Month 6, Month 12

change from baseline, improvement

Safety / tolerability / PK

2 endpoints
Primary/protocol endpoint

Count of Adverse Events

Time frame:Year 1

event count, event

Primary/protocol endpoint

Attrition rate

Time frame:Year 1

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.