The Antihypertensives and Vascular, Endothelial and Cognitive Function Trial (AVEC)

University of Southern California

Status and phase: Completed; Phase 2

Conditions: Aging; Hypertension; Cognitive Impairment

Treatments: Drug: hydrochlorothiazide; Drug: candesartan; Drug: metoprolol, long-acting; Drug: lisinopril; Drug: nifedipine, long acting

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00605072

K23AG030057 (U.S. NIH Grant/Contract)

IA0127

Details and patient eligibility

About

The purpose of this study is to examine the effects of blood pressure medications on cognition and blood flow in hypertensive elderly patients with cognitive impairment. The hypothesis is that treatment with an angiotensin receptor blocker (ARB) or an angiotensin-converting enzyme inhibitor (ACEI) will be associated with a slower rate of further cognitive decline, improved cerebral blood flow and its regulation, and preserved physical function as compared to treatment with a diuretic (HCTZ), independent of blood pressure level.

Full description

There is mounting evidence that hypertension, which affects more than 65% of the US elderly population, accelerates cognitive decline and increases the risk of functional disability among older individuals. Hypertension is also associated with cerebral blood flow reduction and dysregulation which contribute to further cognitive and functional impairment. Drugs that inhibit angiotensin II (ACEI and ARB) are commonly used antihypertensives and may have a protective effect on cognitive function, cerebral blood flow and physical function compared to other antihypertensives such as hydrochlorothiazide (HCTZ).

A total of 100 individuals will be recruited for this pilot 3-arm randomized study to investigate the effects of: (i) 12 months treatment with candesartan (ARB) compared to hydrochlorothiazide (HCTZ) and (ii) 12 months treatment with lisinopril (ACEI) compared to HCTZ and (iii) to estimate the effect size difference between lisinopril and losartan on cognition, cerebral blood flow regulation, and functional measures in a sample of elderly hypertensive individuals with objective evidence of cognitive impairment.

Enrollment: 53 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 60 years or older
• Hypertension
• Cognitive criteria: score either 10 or less out of 15 for the executive clock draw test 1 (CLOX1) or less than or equal to 1 standard deviation from the corresponding age specific mean on the immediate memory subtest

Exclusion criteria

• Intolerance to ACEI or ARB
• History of congestive heart failure
• History of diabetes mellitus
• History of stroke (less than 6 months)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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53 participants in 3 patient groups

Candesartan

Experimental group

Description:

Angiotensin Receptor Blocker

Treatment:

Drug: nifedipine, long acting

Drug: metoprolol, long-acting

Drug: candesartan

Lisinopril

Experimental group

Description:

Angiotensin-Converting Enzyme (ACE) Inhibitor

Treatment:

Drug: nifedipine, long acting

Drug: metoprolol, long-acting

Drug: lisinopril

HCTZ

Active Comparator group

Description:

Hydrochlorothiazide (diuretic)

Treatment:

Drug: hydrochlorothiazide