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Candesartan vs. Lisinopril Effects on the Brain (CALIBREX)

Completed

This study will compare the effects of two high blood pressure medications, candesartan and lisinopril, on the brains of people with high blood pressure and executive mild cognitive impairment. Changes in executive function, neuroimaging markers, and vascular indicators will be measured.

Minimum Age Maximum Age Gender Healthy Volunteers
60 Years N/A Both No
August 2014
December 3, 2018
140

  • High blood pressure (systolic blood pressure ≥140 mm Hg, diastolic blood pressure ≥90 mm Hg, or taking antihypertensive medications)
  • Executive mild cognitive impairment, defined using these criteria: 1) Montreal Cognitive Assessment score of less than 26; 2) Clinical Dementia Rating score of 0.5; 3) 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

  • Intolerance to study drugs
  • Systolic blood pressure of >200 mm Hg or diastolic blood pressure of >110 mm Hg
  • Renal disease or hyperkalemia 4
  • Active medical or psychiatric problems
  • Uncontrolled congestive heart failure
  • History of stroke in the past 3 years
  • Women of childbearing potential
  • Use of acetylcholinesterase inhibitors or NMDA receptor antagonist (memantine)

No specific treatment is available for people with hypertension (high blood pressure) associated with cognitive impairment without dementia. This clinical trial will investigate the effects of two antihypertensives, candesartan and lisinopril, on executive function and other brain changes. The study also seeks to identify the underlying mechanisms related to vascular structure and function.

Participants will be randomly assigned to take one of the study drugs in increasing doses until blood pressure is controlled (<140/90 mmHg). Researchers will measure the drugs' effects on cognitive function; cerebral perfusion and reserve; and markers of vascular brain damage, atherosclerosis, vascular stiffness, vascular inflammation, and endothelial function. Participants will be seen at 3, 6, and 12 months afterwards.

Name City State Zip Status Primary Contact
Emory Univeristy
Atlanta Georgia 30329

Emory University

  • National Institute on Aging (NIA)

Name Role Affiliation
Ihab Hajjar, MD Principal Investigator Emory Univeristy

Name Phone Email
Ihab Hajjar, MD 404-728-6959 ihajjar@emory.edu

NCT01984164

CAndesartan vs LIsinopril Effects on the BRain and Endothelial Function in eXecutive MCI (CALIBREX)