Rationale and methods for a multicenter clinical trial assessing exercise and intensive vascular risk reduction in preventing dementia (rrAD Study).
Rationale and methods for a multicenter clinical trial assessing exercise and intensive vascular risk reduction in preventing dementia (rrAD Study).
复制标题
评估运动和强化血管风险降低预防痴呆症的多中心临床试验的基本原理和方法（rrAD 研究）。
DOI：
10.1016/j.cct.2019.02.007
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发表时间：
2019
影响因子：
2.2
通讯作者：
Keller,JeffreyN
中科院分区：
文献类型：
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作者：
Szabo-Reed,AmandaN;Vidoni,Eric;Binder,EllenF;Burns,Jeffrey;Cullum,CMunro;Gahan,WilliamP;Gupta,Aditi;Hynan,LindaS;Kerwin,DianaR;Rossetti,Heidi;Stowe,AnnM;Vongpatanasin,Wanpen;Zhu,DavidC;Zhang,Rong;Keller,JeffreyN
阿尔茨海默病（AD）是一种与年龄相关的疾病，具有可改变的危险因素，如高血压、高胆固醇血症、肥胖和影响发病和进展的身体活动不足。然而，没有直接证据表明减少这些风险因素可以预防或减缓AD。降低阿尔茨海默病风险（rrAD）试验旨在研究强化药物控制血压和胆固醇以及运动训练对神经认知功能的独立和联合作用。将入组640名年龄在60至85岁之间、认知功能正常、患有高血压且痴呆风险增加的老年人。参与者被随机分为四个干预组之一，为期两年：常规护理，强化降低血管风险因素（IRVR），降低血压和胆固醇，运动训练（EX）和IRVR+EX。在基线、6、12、18和24个月时测量神经认知功能;在基线和24个月时获得脑MRI。我们假设IRVR和EX都将改善整体认知功能，而IRVR+EX将提供比单独IRVR或EX更大的益处。我们还假设IRVR和EX将减缓脑萎缩，改善脑结构和功能连接，并改善脑灌注。最后，我们将探讨研究干预影响神经认知和大脑的机制。如果rrAD干预措施被证明是安全、实用和成功的，我们的研究将对降低老年人AD的风险产生重大影响。NCT注册：NCT 02913664
Alzheimer's Disease (AD) is an age-related disease with modifiable risk factors such as hypertension, hypercholesterolemia, obesity, and physical inactivity influencing the onset and progression. There is however, no direct evidence that reducing these risk factors prevents or slows AD. The Risk Reduction for Alzheimer's Disease (rrAD) trial is designed to study the independent and combined effects of intensive pharmacological control of blood pressure and cholesterol and exercise training on neurocognitive function. Six hundred and forty cognitively normal older adults age 60 to 85 years with hypertension and increased risk for dementia will be enrolled. Participants are randomized into one of four intervention group for two years: usual care, Intensive Reduction of Vascular Risk factors (IRVR) with blood pressure and cholesterol reduction, exercise training (EX), and IRVR+EX. Neurocognitive function is measured at baseline, 6, 12, 18, and 24 months; brain MRIs are obtained at baseline and 24 months. We hypothesize that both IRVR and EX will improve global cognitive function, while IRVR+EX will provide a greater benefit than either IRVR or EX alone. We also hypothesize that IRVR and EX will slow brain atrophy, improve brain structural and functional connectivity, and improve brain perfusion. Finally, we will explore the mechanisms by which study interventions impact neurocognition and brain. If rrAD interventions are shown to be safe, practical, and successful, our study will have a significant impact on reducing the risks of AD in older adults.NCT Registration: NCT02913664