Vascular Intervention Strategies Trial for Alzheimer's (VISTA)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Blood Pressure Control
研究概览
简要总结
The proposed pharmacist-led study is a feasibility pilot trial for the management of vascular risk factors of hypertension and hypercholesterolemia in 10 APOE ε4 carriers, 50-75, at-risk for dementia. All participants will receive angiotensin receptor blockers (ARBs) for high blood pressure, and hydrophilic statins (or a non-statin alternative) for high cholesterol over a six-month period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •APOE ε4 carrier (homozygote or heterozygote)
- •LDL-C of 100-250 mg/dL
- •Systolic blood Pressure (SBP) 130-180 mm Hg
- •Age 50-75 years
- •Fluency in English
- •No dementia based on medical record review
- •Male or post-menopausal female
排除标准
- •One minute standing SBP < 110 mm Hg
- •Arm circumference prevents from accurate BP measurement with use of available devices
- •Lost weight of > 10% unintendedly (within the past 6 months),
- •Contraindications to blood pressure and cholesterol lowering medications
- •Use of medications prescribed for dementia (e.g., aducanumab, donanemab, lecanemab, donepezil, galantamine, rivastigmine, memantine)
- •Evidence of dementia based on medical record review
- •Living in a skilled nursing or rehabilitation facility
- •Receiving palliative or hospice care
- •Bipolar illness or schizophrenia
- •Drug or alcohol disorder
- •Receiving chronic opioid therapy
- •Any significant neurological disease (e.g., Parkinson's disease, amyotrophic lateral sclerosis, or multiple sclerosis)
- •Severe loss of visual, hearing or communication ability
- •Organ transplant
- •History of stroke, symptomatic HF or left ventricular ejection fraction < 35%
- •ESRD or eGFR < 20 ml/min /1.73m2
- •Does not consent to be contacted or to have their medical record reviewed for research purposes
- •Concurrent participation in another clinical trial
研究组 & 干预措施
Pharmacist-Led Vascular Risk Factor Management
Participants receive pharmacist-led management of hypertension and hypercholesterolemia using angiotensin receptor blockers and hydrophilic statins (or non-statin alternatives) over six months.
干预措施: Angiotensin Receptor Blockers (ARBs) (Drug)
Pharmacist-Led Vascular Risk Factor Management
Participants receive pharmacist-led management of hypertension and hypercholesterolemia using angiotensin receptor blockers and hydrophilic statins (or non-statin alternatives) over six months.
干预措施: Hydrophilic Statins or Non-Statin Alternative (Drug)
结局指标
主要结局
Blood Pressure Control
时间窗: Baseline to 6 months
Change in systolic blood pressure (mmHg) from baseline to the end of the 6-month intervention.
次要结局
- Lipid Level Changes(Baseline to 6 months)
- Feasibility Metrics(Study duration (6 months))
研究者
Hussein Yassine
Professor of Neurology and Department of Physiology and Neuroscience; Kenneth and Bette Volk Professorship in Neurology; Director, Center for Personalized Brain Health
University of Southern California