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Cognitive ImpairmentPhase 2AVECNCT00605072

The Antihypertensives and Vascular, Endothelial and Cognitive Function Trial

A Phase 2 study testing candesartan, lisinopril and hydrochlorothiazide in people with Cognitive Impairment and Hypertension, run by University of Southern California at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Cognitive Impairment, Hypertension, Aging
What is being tested?
candesartan, lisinopril and hydrochlorothiazide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
2 sitesUnited States
Study dates
Jan 2008to Dec 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Hebrew SeniorLife

    Boston, Massachusetts, 02131

  • University of Southern California

    Los Angeles, California, 90033

Other trials in United States

About this study

Official title: The Antihypertensives and Vascular, Endothelial and Cognitive Function Trial (AVEC 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.

Read the detailed 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.

Being tested
candesartan, lisinopril, hydrochlorothiazide, nifedipine, long acting, metoprolol, long-acting
Keywords
cognitive disorders, angiotensin receptor blockers
Medical subject headings
Cognitive Dysfunction, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • candesartanDrug

    Also called Atacand

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

  • lisinoprilDrug

    Also called Prinivil

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

  • hydrochlorothiazideDrug

    Also called HCTZ, multiple brand names

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

  • nifedipine, long actingDrug

    Also called Procardia XL

    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

  • metoprolol, long-actingDrug

    Also called Lopressor, Toprol XL

    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

Study groups in NCT00605072
Study groupRoleWhat they receive
CandesartanExperimentalAngiotensin Receptor Blocker
Receives: Drug: candesartan; Drug: nifedipine, long acting; Drug: metoprolol, long-acting
LisinoprilExperimentalAngiotensin-Converting Enzyme (ACE) Inhibitor
Receives: Drug: lisinopril; Drug: nifedipine, long acting; Drug: metoprolol, long-acting
HCTZActive comparatorHydrochlorothiazide (diuretic)
Receives: Drug: hydrochlorothiazide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cognitive Assessment: Trail Making Test Part B

    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.

    Measured: Baseline-12 months

  2. Cognitive Assessment: Hopkins Verbal Learning- Immediate Recall

    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)

    Measured: Baseline-12 months

  3. Cognitive Assessment: Forward Digit Span Test

    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)

    Measured: Baseline-12 months

Secondary outcomes (2)

  1. Blood Pressure Outcome: Systolic BP

    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

    Measured: Baseline-12 months

  2. Blood Flow Velocity, Sitting

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

    Measured: Baseline-12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2008 (estimated)
  2. Study startJan 2008
  3. Primary completionDec 2011
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00605072
Sponsor's protocol ID
IA0127
Other IDs
K23AG030057
Acronym
AVEC
Status last verified
Jan 2013
First submitted
11 Jan 2008
Last updated
15 Feb 2013
Data monitoring committee
No

Publications

  • Lipsitz LA, Gagnon M, Vyas M, Iloputaife I, Kiely DK, Sorond F, Serrador J, Cheng DM, Babikian V, Cupples LA. Antihypertensive therapy increases cerebral blood flow and carotid distensibility in hypertensive elderly subjects. Hypertension. 2005 Feb;45(2):216-21. doi: 10.1161/01.HYP.0000153094.09615.11. Epub 2005 Jan 17.

    PubMed 15655124

  • Hajjar I, Hart M, Milberg W, Novak V, Lipsitz L. The rationale and design of the antihypertensives and vascular, endothelial, and cognitive function (AVEC) trial in elderly hypertensives with early cognitive impairment: role of the renin angiotensin system inhibition. BMC Geriatr. 2009 Nov 18;9:48. doi: 10.1186/1471-2318-9-48.

    PubMed 19922631

  • Hajjar I, Hart M, Chen YL, Mack W, Milberg W, Chui H, Lipsitz L. Effect of antihypertensive therapy on cognitive function in early executive cognitive impairment: a double-blind randomized clinical trial. Arch Intern Med. 2012 Mar 12;172(5):442-4. doi: 10.1001/archinternmed.2011.1391. No abstract available.

    PubMed 22412114

  • Hajjar I, Hart M, Chen YL, Mack W, Novak V, C Chui H, Lipsitz L. Antihypertensive therapy and cerebral hemodynamics in executive mild cognitive impairment: results of a pilot randomized clinical trial. J Am Geriatr Soc. 2013 Feb;61(2):194-201. doi: 10.1111/jgs.12100. Epub 2013 Jan 25.

    PubMed 23350899

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing candesartan, lisinopril and hydrochlorothiazide in people with Cognitive Impairment and Hypertension, run by University of Southern California at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cognitive Assessment: Trail Making Test Part B (time frame: Baseline-12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00605072, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2013.

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