CAndesartan vs LIsinopril Effects on the BRain

• Status: Completed
• Trial end date: 2018-12-03
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to conduct a 1-year double blind randomized control trial comparing candesartan to lisinopril in 140 individuals with hypertension and executive mild cognitive impairment in their effects on executive function, neuroimaging markers, and vascular indicators.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University; Ihab M. Hajjar
• Collaborator: National Institute on Aging (NIA)
• Treatments: Candesartan; Candesartan cilexetil; Lisinopril; Metoprolol

Criteria

Inclusion Criteria:

1. age: 55 years or older;

2. Hypertension: SBP≥140 mm Hg or DBP≥ 90 mm or receiving antihypertensive medications.

3. Executive MCI will be defined using these criteria:

1. The Montreal Cognitive Assessment (MoCA) score less than or equal to 26

2. Executive dysfunction: A performance at the 10th percentile or below on at least one of four screening tests for executive function: Trail Making Test, Part B (TMT-B), modified Stroop interference, Digit Span and Digit Sequencing, and Letter fluency.

3. Minimal Functional limitation as reflected by the Functional Assessment Questionnaire (FAQ)≤7

Exclusion Criteria:

1. Intolerance to study drugs;

2. SBP >200 or DBP >110 mm Hg;

3. Renal disease or hyperkalemia

4. Active medical or psychiatric problems

5. Uncontrolled congestive heart failure;

6. History of stroke in the past 3 years;

7. Inability to perform the study procedures

8. Women of childbearing potential

9. diagnosis of dementia

10. In those who lack decision capacity, a study surrogate who can sign on their behalf will be required. Since we are enrolling only those with MCI, we anticipate that most participants will have decision capacity

11. Current use of Lithium, as most antihypertensive classes may lead to increased lithium toxic levels.