Overview
CAndesartan vs LIsinopril Effects on the BRain
Status:
Completed
Completed
Trial end date:
2018-12-03
2018-12-03
Target enrollment:
0
0
Participant gender:
All
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 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Emory University
Ihab M. HajjarCollaborator:
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.