INtervention for Cognitive Reserve Enhancement in delaying the onset of Alzheimer's Symptomatic Expression (INCREASE), a randomized controlled trial: rationale, study design, and protocol
INtervention for Cognitive Reserve Enhancement in delaying the onset of Alzheimer's Symptomatic Expression (INCREASE), a randomized controlled trial: rationale, study design, and protocol
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DOI：
10.1186/s13063-019-3993-0
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发表时间：
2019-12-30
期刊：
影响因子：
2.5
通讯作者：
Jicha, Gregory A.
中科院分区：
文献类型：
--
作者：
Moga, Daniela C.;Beech, Brooke F.;Jicha, Gregory A.
背景资料：阿尔茨海默病（AD）的病程包括10-20年的临床前时期，在没有症状性认知或功能下降的情况下，淀粉样蛋白β（A β）斑块和神经系统缠结进行性积累。该临床前阶段的持续时间部分取决于病理进展的速率，其被称为认知储备（CR）的代偿机制抵消。共病的医疗条件，心理社会压力，和不适当的药物使用可能会降低CR，加速症状性AD的发作。在这里，我们描述了一个随机对照试验（RCT），旨在测试药物治疗管理（MTM）干预的疗效，以减少不适当的药物使用，支持认知储备，并最终延迟症状性AD。方法/设计：我们的研究旨在招募90名非痴呆社区居民≥ 65岁的成年人。参与者将接受正电子发射断层扫描（PET）扫描，使用标准化摄取值比率（SUVr）测量A β水平。参与者将被随机分配到MTM干预或对照组，按A β水平分层，并通过面对面和电话访视随访12个月。关注的结果包括：（1）药物适当性（用药物适当性指数（MAI）测量）;（2）连线测验B（TMT B）、蒙特利尔认知评估（莫卡）和加州语言学习测验（CVLT）的评分;（3）自觉健康状况（用SF-36测量）。我们还将评估干预前后的变化：（1）通过MAI测量的不适当药物的使用; 2）CR变化评分（CRCS），定义为基线和随访时东莨菪碱激发与未激发认知评分的差异。基线A β SUVr将用于检查临床前AD（pAD）病理对CRCS的相对影响，以及淀粉样蛋白负荷与不适当药物使用的相互作用。（“在延迟阿尔茨海默氏症症状表达的发作中对认知储备增强的干预”）：一项随机对照试验，研究取消不适当药物处方和优化药物治疗方案对延迟症状性AD和AD相关痴呆发作的影响。
Background: The course of Alzheimer's disease (AD) includes a 10-20-year preclinical period with progressive accumulation of amyloid beta (A beta) plaques and neurofibrillary tangles in the absence of symptomatic cognitive or functional decline. The duration of this preclinical stage in part depends on the rate of pathologic progression, which is offset by compensatory mechanisms, referred to as cognitive reserve (CR). Comorbid medical conditions, psychosocial stressors, and inappropriate medication use may lower CR, hastening the onset of symptomatic AD. Here, we describe a randomized controlled trial (RCT) designed to test the efficacy of a medication therapy management (MTM) intervention to reduce inappropriate medication use, bolster cognitive reserve, and ultimately delay symptomatic AD.Methods/design: Our study aims to enroll 90 non-demented community-dwelling adults >= 65 years of age. Participants will undergo positron emission tomography (PET) scans, measuring A beta levels using standardized uptake value ratios (SUVr). Participants will be randomly assigned to MTM intervention or control, stratified by A beta levels, and followed for 12 months via in-person and telephone visits. Outcomes of interest include: (1) medication appropriateness (measured with the Medication Appropriateness Index (MAI)); (2) scores from Trail Making Test B (TMTB), Montreal Cognitive Assessment (MoCA), and California Verbal Learning Test (CVLT); (3) perceived health status (measured with the SF-36). We will also evaluate pre- to post-intervention change in: (1) use of inappropriate medications as measured by MAI; 2) CR Change Score (CRCS), defined as the difference in scopolamine-challenged vs unchallenged cognitive scores at baseline and follow-up. Baseline A beta SUVr will be used to examine the relative impact of preclinical AD (pAD) pathology on CRCS, as well as the interplay of amyloid burden with inappropriate medication use.Discussion: This manuscript describes the protocol of INCREASE ("INtervention for Cognitive Reserve Enhancement in delaying the onset of Alzheimer's Symptomatic Expression"): a randomized controlled trial that investigates the impact of deprescribing inappropriate medications and optimizing medication regimens on potentially delaying the onset of symptomatic AD and AD-related dementias.