CAndesartan vs LIsinopril Effects on the BRain
Information source: Emory University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension; Mild Cognitive Impairment
Intervention: Candesartan (Drug); Lisinopril (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Ihab M. Hajjar Official(s) and/or principal investigator(s): Ihab Hajjar, MD, MS, Principal Investigator, Affiliation: Emory Univeristy
Overall contact: Ihab Hajjar, MD, MS, Phone: 4047286959, Email: ihajjar@emory.edu
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.
Clinical Details
Official title: CAndesartan vs LIsinopril Effects on the BRain and Endothelial Function in eXecutive MCI (CALIBREX)
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Primary outcome: Executive function (EXAMINER score)
Secondary outcome: Perfusion and Vasoreactivity (VR)rs-fMRI
Detailed description:
- Hypertension is associated with cognitive impairment even in the absence of clinical
dementia. To date, no specific treatment is available for this pattern of mild
cognitive impairment related to hypertension.
- Objectives or purpose: The aims of this study are to investigate the effects of
candesartan on executive function decline and on changes in cerebral perfusion,
cerebrovascular reserve and microvascular brain injury. The study also intends to
identify potential underlying mechanisms related to vascular structure and function,
including atherosclerosis, vascular inflammation, vascular stiffness, and endothelial
progenitor cells, by which candesartan may affect the cognitive and cerebrovascular
outcomes.
- Study methodology: This is a double blind randomized clinical trial that will be
conducted in 140 individuals (70 in the candesartan group, 70 in the lisinopril group).
Our target population is subjects: 60 years or older with hypertension and Executive
Mild Cognitive Impairment.
- Endpoints to be measured: Our measures include cognitive function, cerebral perfusion
and reserve, markers of vascular brain damage, atherosclerosis, stiffness, vascular
inflammation and endothelial function.
- Description of intervention, follow-up, and duration of study: Eligible participants
will undergo randomization into 2 groups and will be seen frequently until their blood
pressure is controlled (<140/90 mmHg). Participants will be seen at 3, 6 and 12 months
afterwards.
Eligibility
Minimum age: 55 Years.
Maximum age: N/A.
Gender(s): Both.
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 26
2. Clinical Dementia Rating (CDR) score of 0. 5,
3. 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, verbal fluency (number of D words in 1
minute), or abstractions.
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
Locations and Contacts
Ihab Hajjar, MD, MS, Phone: 4047286959, Email: ihajjar@emory.edu
Emory Univeristy, Atlanta, Georgia 30329, United States; Recruiting Ihab Hajjar, MD, Phone: 404-728-6959, Email: ihajjar@emory.edu
Additional Information
Starting date: August 2014
Last updated: May 20, 2015
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