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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

Page last updated: August 23, 2015

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