The Antihypertensives and Vascular, Endothelial and Cognitive Function Trial (AVEC Trial)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Cognitive Assessment: Trail Making Test Part B
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Intolerance to ACEI or ARB
- •History of congestive heart failure
- •History of diabetes mellitus
- •History of stroke (less than 6 months)
研究组 & 干预措施
Candesartan
Angiotensin Receptor Blocker
干预措施: candesartan (Drug)
Candesartan
Angiotensin Receptor Blocker
干预措施: nifedipine, long acting (Drug)
Candesartan
Angiotensin Receptor Blocker
干预措施: metoprolol, long-acting (Drug)
Lisinopril
Angiotensin-Converting Enzyme (ACE) Inhibitor
干预措施: lisinopril (Drug)
Lisinopril
Angiotensin-Converting Enzyme (ACE) Inhibitor
干预措施: nifedipine, long acting (Drug)
Lisinopril
Angiotensin-Converting Enzyme (ACE) Inhibitor
干预措施: metoprolol, long-acting (Drug)
HCTZ
Hydrochlorothiazide (diuretic)
干预措施: hydrochlorothiazide (Drug)
结局指标
主要结局
Cognitive Assessment: Trail Making Test Part B
时间窗: 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.
Cognitive Assessment: Hopkins Verbal Learning- Immediate Recall
时间窗: 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)
Cognitive Assessment: Forward Digit Span Test
时间窗: 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)
次要结局
- Blood Pressure Outcome: Systolic BP(Baseline-12 months)
- Blood Flow Velocity, Sitting(Baseline-12 months)
研究者
Ihab Hajjar
Assistant Professor of Medicine
University of Southern California