ADCS prevention instrument project: Overview and initial results
ADCS prevention instrument project: Overview and initial results
复制标题
DOI：
10.1097/01.wad.0000213870.40300.21
复制
发表时间：
2006-10-01
影响因子：
2.1
通讯作者：
Thal, Leon J.
中科院分区：
文献类型：
--
作者：
Ferris, Steven H.;Aisen, Paul S.;Thal, Leon J.
阿尔茨海默病合作研究（ADCS）的目标之一是开发新的或改进的仪器和评估方法来评估阿尔茨海默病（AD）临床试验的治疗效果。ADCS仪器委员会以前曾帮助确定AD和轻度认知障碍临床试验评估的最新技术。我们现在正进入一个令人兴奋的初级预防试验时代，以评估可能延迟疾病发病的有希望的治疗方法，需要为这些试验开发适当的工具。ADCS工具委员会开展了一个项目，开发预防研究工具，评估已知在AD中重要的领域。预防试验耗时长，需要大量受试者，成本高昂，受试者的参与负担也很高。目前的研究重点是开发可以在家里和诊所完成的仪器。这些工具正在一组参加4年纵向研究的无痴呆老年人中进行评估，该研究模拟了初级预防试验的设计。本报告描述了通过完成前2年随访的研究队列的设计、基线特征和一些纵向结果。我们还描述了用我们的新实验仪器测量的评估域。这项研究招募了644名年龄在75岁及以上的受试者。参加一个为老年人提供免费书籍的“读书俱乐部”是一种招聘激励。大约23%的人有一些轻微的认知症状，符合0.5的临床痴呆评分。所有受试者在基线时都接受了标准化的临床评估，该评估每年重复一次，持续4年，以确定疑似发展为痴呆的病例，并测量已建立的临床评估的纵向变化。受试者在家中或诊所完成了一套自我管理的实验工具，旨在评估认知功能和行为、整体变化、日常生活活动、生活质量和资源利用。另一份“邮寄认知功能问卷”在其他评估前1个月通过邮寄方式获得。为了评估以家庭为基础的工具与在诊所访问中获取相同信息的可行性、效率和有效性，受试者被随机分为2个条件中的1个，其中基线和年度随访评估在家中完成（“家庭组”）或在诊所访问期间在研究地点完成（“诊所组”）。这份初步报告描述了正在进行的为期4年的纵向研究，并提供了基线结果，证实了通过邮件或电话获取家庭临床信息的可行性。实验仪器和读书俱乐部的初步结果分别在随附的文章中报告。
One objective of the Alzheimer's Disease Cooperative Study (ADCS) is to develop new or improved instruments and assessment methods for evaluating treatment efficacy in Alzheimer disease (AD) clinical trials. The ADCS Instrument Committee has previously helped to define the state of the art in assessment for AD and Mild Cognitive Impairment clinical trials. We are now entering an exciting era of primary prevention trials to evaluate promising treatments that may delay disease onset and there is a need to develop appropriate instruments for these trials. The ADCS instrument committee has undertaken a project to develop instruments for prevention studies that assess domains known to be important in AD. Prevention trials are long and require large numbers of subjects, making them costly and requiring a high burden of participation for subjects. The current study focused on developing instruments that can be completed at home and in the clinic. The instruments are being evaluated in a cohort of nondemented elderly participating in a 4-year longitudinal study that simulates the design of a primary prevention trial. This report describes the design, baseline characteristics, and some longitudinal outcomes of the study cohort through the completion of the first 2 years of follow-up. We also describe the assessment domains to be measured with our new experimental instruments. This study recruited 644 subjects, 75 years of age and older. Participation in a "book club" that provided free books of interest to elders was offered as a recruitment incentive. Approximately 23% had some mild cognitive symptoms consistent with a Clinical Dementia Rating of 0.5. All subjects received a standardized in-clinic evaluation at baseline, which is repeated annually for 4 years to identify cases suspected of developing dementia and to measure longitudinal change on established clinical assessments. Subjects completed a set of self-administered experimental instruments at home or in the clinic designed to assess cognitive function and behavior, global change, activities of daily living, quality of life, and resource use. An additional "mail-in cognitive function questionnaire" was obtained separately by mail, 1 month before the other assessments. To evaluate the feasibility, efficiency, and validity of the home-based instruments in comparison with acquiring the same information during a clinic visit, subjects were randomized to I of 2 conditions in which the baseline and annual follow-up assessments are completed either at home ("home group") or at the study site during their clinic visits ("clinic group"). This initial report describes the ongoing 4-year longitudinal study and provides baseline results, which confirm the feasibility of obtaining home-based clinical information via mail or telephone. Initial results for the experimental instruments and for the book club are reported in separate accompanying articles.