Mild Cognitive ImpairmentPhase 4STANDNCT04522739
Spironolactone Safety in African Americans With Mild Cognitive Impairment and Early Dementia
A Phase 4 study testing Spironolactone in people with Mild Cognitive Impairment and Alzheimer Disease, run by Emory University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer Disease
- What is being tested?
- Spironolactone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2022to 23 Sep 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory Clinic at Executive Park
Atlanta, Georgia, 30329
About this study
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.
Read the detailed description
In 2018, 5.5 million older adults in the United States were diagnosed with Alzheimer's disease, and it is predicted that 15 million people will be diagnosed with dementia, including Alzheimer's disease by 2060. Older African Americans adults are more likely to be diagnosed with Alzheimer's disease as compared to Whites. Research search studies on high blood pressure show that African Americans have higher levels of the hormone aldosterone that can be involved with regulation of blood pressure and blood vessels. Research studies also show that changes in blood vessels in the brain from higher aldosterone levels are related to changes in thinking skills and memory (cognition). Spironolactone is a drug that blocks aldosterone and has been used to treat high blood pressure for 60 years. More recently, this drug has shown to have the potential to decrease declines in thinking skills and memory.
Spironolactone is widely used in clinical practice and is well-tolerated by younger and older persons. As such, this study is designed to learn how a small group of older African American adults with mild cognitive impairment will tolerate the drug. Persons who are eligible for the study and agree to participate will receive spironolactone or a placebo and be monitored for drug side effects for one year.
During the study, the researchers will monitor changes in thinking and memory and blood vessel stiffness, in addition to side effects that may be related to the drug. Study tests include questionnaires that evaluate thinking skills and memory, and an ultrasound that measures the stiffness of blood vessels in the neck which deliver blood to the brain. The thinking and memory tests and ultrasound will be performed at the beginning of the study, then repeated at the end of the study.
The results of this study can justify a larger size study of spironolactone in older African Americans with mild cognitive impairment. The study has the potential to identify a new use for a well-known drug that is safe and widely used in current clinical practice. Further, the results from this study can address a racial difference in Alzheimer's disease and preserve the health of the brain as people age.
- Conditions
- Mild Cognitive Impairment, Alzheimer Disease
- Being tested
- Spironolactone, Placebo
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpironolactoneDrug
Also called Aldactone
Study participants will receive a 25 mg dose of spironolactone. Participants will take one capsule by mouth per day for 12 months.
PlaceboDrug
A placebo to match spironolactone will be taken orally once per day for 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Spironolactone | Experimental | Participants with mild cognitive impairment or early Alzheimer's Disease who are randomized to receive spironolactone for 12 months. Receives: Drug: Spironolactone |
| Placebo | Placebo comparator | Participants with mild cognitive impairment or early Alzheimer's Disease who are randomized to receive a placebo to match spironolactone for 12 months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Count of Adverse Events
The safely of the study treatment will be assessed with the number of adverse events experienced in each study arm.
Measured: Year 1
Attrition rate
The tolerability of the study treatment will be assessed by the attrition rate of participants in each study arm.
Measured: Year 1
Secondary outcomes (6)
Change in Trail Making Test Part A Score
In Part A of the Trail Making Test (TMT) participants are presented with a sheet of paper with 25 circles numbered 1 through 25. Participants are asked to draw lines connecting the circles in ascending order of the numbers. The task is scored as the amount of time it takes in seconds for the circles to be correctly connected. The average time to complete the task is 29 seconds. Times greater than 78 seconds indicate cognitive impairment.
Measured: Baseline, Month 6, Month 12
Change in Trail Making Test Part B Score
Part B of the Trail Making Test (TMT) includes a sheet of paper with circles with numbers (1-13) and letters (A-L). Participants are asked to draw lines connecting the circles in ascending order of the numbers and letters, alternating between numbers and letters. The task is scored as the amount of time it takes in seconds for the circles to be correctly connected. The average time to complete the task is 75 seconds. Times greater than 273 seconds indicate cognitive impairment.
Measured: Baseline, Month 6, Month 12
Change in Hopkins Verbal Learning Test-Revised (HVLT-R) Total Recall Score
In the HVLT-R recall task, there are three trials where participants hear 12 words which they are asked to recall. The Total Recall score is the sum of correct responses over the three trials. Total scores range from 0 to 36 where higher scores indicate better recall.
Measured: Baseline, Month 6, Month 12
Change in Hopkins Verbal Learning Test-Revised (HVLT-R) Delayed Recall Score
In the HVLT-R delayed recall task, participants hear 12 words and are asked to recall the words after waiting 20-25 minutes. The score is the sum of correctly recalled words and the score ranges from 0 to 12, where higher values indicate better delayed recall.
Measured: Baseline, Month 6, Month 12
Change in Hopkins Verbal Learning Test-Revised (HVLT-R) Recognition Discrimination Index Score
In the HVLT-R recognition task, participants hear 24 words (half of which they have heard before) and are asked each each word has been previously presented. The recognition discrimination is calculated as the number of true positives minus the number of false positives during the recognition task. Index scores can range from -12 to 12 with higher scores indicating better recognition discrimination.
Measured: Baseline, Month 6, Month 12
Change in Digit Span Test Score
The Digit Span test being used is a subtest of the Wechsler Adult Intelligence Scale - Third Edition (WAIS-III) and assesses immediate memory and attention. Participants are asked to repeat strings of numbers forwards and backwards. The score is the number of digits that are repeated correctly. Higher scores indicate improved memory and attention.
Measured: Baseline, Month 6, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start6 Sep 2022
- Primary completion23 Sep 2025
- Study completion23 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer's Association
- Responsible party
- Principal investigator, Antoine Trammell, Emory University
- Investigators
- Antoine Trammell, MD, MPH, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04522739
- Sponsor's protocol ID
- STUDY00000124
- Acronym
- STAND
- Status last verified
- Oct 2026
- First submitted
- 19 Aug 2020
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification, will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spironolactone Safety in African Americans With Mild Cognitive Impairment and Early Dementia
- ClinicalTrials.gov ID
- NCT04522739
- Acronym / sponsor ID
- STAND / STUDY00000124
- Conditions
- Mild Cognitive Impairment, Alzheimer Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Alzheimer's Association
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 23 Sep 2025 (actual)
- Study completion
- 23 Sep 2025 (actual)
- First posted
- 21 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In 2018, 5.5 million older adults in the United States were diagnosed with Alzheimer's disease, and it is predicted that 15 million people will be diagnosed with dementia, including Alzheimer's disease by 2060. Older African Americans adults are more likely to be diagnosed with Alzheimer's disease as compared to Whites. Research search studies on high blood pressure show that African Americans have higher levels of the hormone aldosterone that can be involved with regulation of blood pressure and blood vessels. Research studies also show that changes in blood vessels in the brain from higher aldosterone levels are related to changes in thinking skills and memory (cognition). Spironolactone is a drug that blocks aldosterone and has been used to treat high blood pressure for 60 years. More recently, this drug has shown to have the potential to decrease declines in thinking skills and memory.
Spironolactone is widely used in clinical practice and is well-tolerated by younger and older persons. As such, this study is designed to learn how a small group of older African American adults with mild cognitive impairment will tolerate the drug. Persons who are eligible for the study and agree to participate will receive spironolactone or a placebo and be monitored for drug side effects for one year.
During the study, the researchers will monitor changes in thinking and memory and blood vessel stiffness, in addition to side effects that may be related to the drug. Study tests include questionnaires that evaluate thinking skills and memory, and an ultrasound that measures the stiffness of blood vessels in the neck which deliver blood to the brain. The thinking and memory tests and ultrasound will be performed at the beginning of the study, then repeated at the end of the study.
The results of this study can justify a larger size study of spironolactone in older African Americans with mild cognitive impairment. The study has the potential to identify a new use for a well-known drug that is safe and widely used in current clinical practice. Further, the results from this study can address a racial difference in Alzheimer's disease and preserve the health of the brain as people age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spironolactone | Experimental | Drug: SpironolactoneParticipants with mild cognitive impairment or early Alzheimer's Disease who are randomized to receive spironolactone for 12 months. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants with mild cognitive impairment or early Alzheimer's Disease who are randomized to receive a placebo to match spironolactone for 12 months. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
- MCI defined as:
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpironolactoneAlso: AldactoneStudy participants will receive a 25 mg dose of spironolactone. Participants will take one capsule by mouth per day for 12 months. | Drug | Spironolactone |
| PlaceboA placebo to match spironolactone will be taken orally once per day for 12 months. | Drug | Placebo |
Primary outcome
Count of Adverse Events
Time frame: Year 1
The safely of the study treatment will be assessed with the number of adverse events experienced in each study arm.
Attrition rate
Time frame: Year 1
The tolerability of the study treatment will be assessed by the attrition rate of participants in each study arm.
6 secondary outcomes
Change in Trail Making Test Part A Score
Time frame: Baseline, Month 6, Month 12
Change in Trail Making Test Part B Score
Time frame: Baseline, Month 6, Month 12
Change in Hopkins Verbal Learning Test-Revised (HVLT-R) Total Recall Score
Time frame: Baseline, Month 6, Month 12
Change in Hopkins Verbal Learning Test-Revised (HVLT-R) Delayed Recall Score
Time frame: Baseline, Month 6, Month 12
Change in Hopkins Verbal Learning Test-Revised (HVLT-R) Recognition Discrimination Index Score
Time frame: Baseline, Month 6, Month 12
Change in Digit Span Test Score
Time frame: Baseline, Month 6, Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification, will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoine Trammell, MD, MPH principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Spironolactone in people with Mild Cognitive Impairment and Alzheimer Disease, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Count of Adverse Events (time frame: Year 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.