The Alzheimer's Disease Cooperative Study - Activities of Daily Living dependence score: revision and validation of an algorithm evaluating patient dependence across the spectrum of AD severity.

IF 4.3 Q2 BUSINESS
Julie M Chandler, Claire J Lansdall, Wenyu Ye, Fiona McDougall, Mark Belger, Balazs Toth, Xiaojuan Mi, Kaycee M Sink, Alexandra S Atkins
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引用次数: 0

Abstract

Background: Increasing dependence on informal and formal caregivers in Alzheimer's disease (AD) contributes to high societal cost. Treatments that delay time to increased dependence/care needs would be clinically meaningful, but these outcomes are rarely collected in early AD clinical trials. The 2015 ADCS-ADL dependence algorithm was created to estimate level of dependence in AD.

Objectives: To revise the original dependence algorithm to improve accuracy of dependence scores (DS) across AD severity, including early symptomatic AD.

Design: Secondary data analysis SETTING: Community cohort; randomized clinical trial PARTICIPANTS: 14,000 participants enrolled across GERAS-EU observational study and 12 AD clinical trials.

Measurements: Three-phase algorithm revision: 1) reassess ADCS-ADL items to identify those appropriate for assessing dependence; 2) (a) assign individual item responses to degrees of assistance and (b) to operationalize assignment of DS based on extent of total assistance needed; and 3) validate revised algorithm in multiple datasets across AD severity from mild cognitive impairment due to AD to moderate-severe AD.

Results: The revised DS (0-6) algorithm classified most participants with early symptomatic AD as independent or moderately independent (DS<3) at baseline. With disease progression over time, the proportion of participants who were mildly to fully dependent (DS≥3) increased across AD severity. Increased DS was associated with incremental worsening of clinical outcomes.

Conclusions: The revised ADCS-ADL DS algorithm provides a supplementary approach to evaluate the impact of emerging treatments on independence/care needs in AD and may be useful in clinical trials where the ADCS-ADL has been collected.

Clinical trial registration information: EXPEDITION 1 NCT00905372; EXPEDITION 2 NCT00904683; EXPEDITION 3 NCT01900665; AMARANTH NCT02245737; TRAILBLAZER-ALZ NCT03367403; TRAILBLAZER-ALZ 2 NCT04437511; GRADUATE I NCT03444870; GRADUATE II NCT03443973; CREAD NCT02670083; CREAD 2, NCT03114657; TAURIEL NCT03289143; LAURIET NCT03828747.

阿尔茨海默病合作研究-日常生活依赖活动评分:一种评估AD严重程度患者依赖程度的算法的修订和验证。
背景:阿尔茨海默病(AD)患者对非正式和正式护理人员的依赖日益增加,造成了较高的社会成本。延迟对依赖性/护理需求增加的时间的治疗在临床上是有意义的,但这些结果很少在早期阿尔茨海默病临床试验中收集到。建立了2015 ADCS-ADL依赖算法来估计AD的依赖程度。目的:改进原有的依赖算法,提高不同AD严重程度(包括早期症状性AD)的依赖评分(DS)的准确性。设计:二次数据分析设置:社区队列;随机临床试验参与者:14000名参与者参加了GERAS-EU观察性研究和12项AD临床试验。测量:三阶段算法修订:1)重新评估ADCS-ADL项目,以确定适合评估依赖性的项目;2) (a)按援助程度分配个别项目的回应,以及(b)根据需要的总援助程度,实施分配安全措施;3)在不同AD严重程度(从轻度AD导致的认知障碍到中重度AD)的多个数据集上验证改进后的算法。结果:修订后的DS(0-6)算法将大多数早期症状性AD参与者划分为独立或中度独立(DS)。结论:修订后的ADCS-ADL DS算法提供了一种补充方法来评估新兴治疗方法对AD患者独立性/护理需求的影响,可能在收集ADCS-ADL的临床试验中有用。临床试验注册信息:EXPEDITION 1 NCT00905372;远征2号nct00904683;远征3 nct01900665;苋菜NCT02245737;TRAILBLAZER-ALZ NCT03367403;开拓者- alz 2 nct04437511;研究生一级nct03444870;研究生ii nct03443973;CREAD NCT02670083;Cread 2, nct03114657;TAURIEL NCT03289143;LAURIET NCT03828747。
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来源期刊
The Journal of Prevention of Alzheimer's Disease
The Journal of Prevention of Alzheimer's Disease Medicine-Psychiatry and Mental Health
CiteScore
9.20
自引率
0.00%
发文量
0
期刊介绍: The JPAD Journal of Prevention of Alzheimer’Disease will publish reviews, original research articles and short reports to improve our knowledge in the field of Alzheimer prevention including: neurosciences, biomarkers, imaging, epidemiology, public health, physical cognitive exercise, nutrition, risk and protective factors, drug development, trials design, and heath economic outcomes.JPAD will publish also the meeting abstracts from Clinical Trial on Alzheimer Disease (CTAD) and will be distributed both in paper and online version worldwide.We hope that JPAD with your contribution will play a role in the development of Alzheimer prevention.
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