Skip to main content
OpenTrials
Completed

NCT Number: NCT00605072

The Antihypertensives and Vascular, Endothelial and Cognitive Function Trial

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cognitive Impairment Aging Cardiovascular Diseases Cognition Disorders Cognitive Dysfunction Hypertension Mental Disorders Neurocognitive Disorders Vascular Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Southern California, Los Angeles, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Candesartan

Drug

orally 8 mg increased to 16 mg then 32 mg to achieve target blood pressure of 140/90, then daily for 12 months

Other names: Atacand

Lisinopril

Drug

orally 10 mg increased to 20 mg then 40 mg to achieve target blood pressure of 140/90, then daily for 12 months

Other names: Prinivil

Hydrochlorothiazide

Drug

orally 12.5 mg increased to 25 mg to achieve target blood pressure of 140/90, then daily for 12 months

Other names: HCTZ, multiple brand names

nifedipine, long acting

Drug

If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments

Other names: Procardia XL

metoprolol, long-acting

Drug

If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg

Other names: Lopressor, Toprol XL

Primary outcomes

  1. Cognitive Assessment: Trail Making Test Part B

    Time frame: Baseline-12 months

    This test requires the connection of sequentially numbered circles (A), and the connection of circles marked by numbers and letters in alternating sequence (B). This test is considered a benchmark of executive function. The test score is the time required to complete the task in seconds.

  2. Cognitive Assessment: Hopkins Verbal Learning- Immediate Recall

    Time frame: Baseline-12 months

    This is a 12-item list learning test in which individuals are presented three learning and recall trials followed by a delayed recall and 24 item recognition test. The HVLT-R has been identified as an ideal memory measure for elderly patients, and appropriate reliability and validity have been shown in older individuals. The test score is the number of correct answers in the delayed recall ( score range 0-12)

  3. Cognitive Assessment: Forward Digit Span Test

    Time frame: Baseline-12 months

    This test consists of series of digits of increasing length, some of which are recited as presented, and some of which are to be recited in reversed order. The forward digit span score ranges from 0 (ie cannot repeat two digits) to 8 ( participant can repeat up to 8 digits)

Secondary outcomes

  1. Blood Pressure Outcome: Systolic BP

    Time frame: Baseline-12 months

    Blood pressure was measured as follows: the participant was in the sitting position, rested for 5 minutes, no caffeine or smoking 2 hours prior to measurement, using appropriate cuff size (covering 60% of upper arm length and 80% of arm circumference), correct cuff placement (1-2 inches above brachial pulse on bare arm), and the bell of the stethoscope. The systolic blood pressure was defined as the pressure corresponding to the first korotkoff sounds (K1) and the diastolic as the pressure corresponding to the last korotkoff sound (K5). Blood pressure was measured in both arms and recorded

  2. Blood Flow Velocity, Sitting

    Time frame: Baseline-12 months

    This reports the change in the least square mean from baseline to 12 months, adjusted for age

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • Hebrew SeniorLife
  • National Institute on Aging (NIA)

Registry information

Official study title

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

Acronym: AVEC

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Jan 30, 2008
Registry last updated
Feb 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.