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

• Status: Not yet recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

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). 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Collaborator: Alzheimer's Association
• Treatments: Spironolactone

Criteria

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:

• Subjective memory concern

• 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

• MoCA score 16-25

• Preserved general functional performance per Functional Assessment Questionnaire (FAQ)<9

Exclusion Criteria:

• History of stroke in the previous three years

• MOCA<10 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/surrogate is not available to sign consent forms on their behalf