Adding delayed recall to the Alzheimer Disease Assessment Scale is useful in studies of mild cognitive impairment but not Alzheimer disease.
Adding delayed recall to the Alzheimer Disease Assessment Scale is useful in studies of mild cognitive impairment but not Alzheimer disease.
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DOI：
10.1097/wad.0b013e3181f883b7
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发表时间：
2011-04
影响因子：
2.1
通讯作者：
Aisen PS
中科院分区：
文献类型：
--
作者：
Sano M;Raman R;Emond J;Thomas RG;Petersen R;Schneider LS;Aisen PS
确定在轻度认知障碍（MCI）和阿尔茨海默病（AD）的临床试验中，增加延迟回忆（DR）评估是否增加了阿尔茨海默病评估量表（ADAS-cog）认知子量表的敏感性。记忆，特别是DR，是早期检测AD和MCI的最敏感的测试。然而，目前尚不清楚DR评估是否有助于在诊断后或临床试验中测量随时间的变化。ADAS-cog是AD临床试验中评估治疗疗效的最常用工具。为了提高对变化的敏感性，在标准的11项ADAS-cog中添加了3次试验后的DR评估，10个单词的列表。我们研究了DR在MCI和AD参与者中的附加值，随访至少1年。纳入了随机分配至2项临床试验安慰剂组的111例AD受试者和259例MCI受试者的数据。AD患者的简易精神状态检查得分为13至27分，MCI患者为24至30分。我们根据原始的11个项目（范围：最好到最差，0到70）、DR项目评分（范围：0到10个未回忆起的单词）和ADAS-cog 12（范围：0到80）计算ADAS-cog 11评分。我们评估了DR随时间推移的缺失项目率、变化评分、评分与基线表现之间的相关性，并使用纵向混合效应回归模型来检查变化率。基线时，AD受试者的DR接近下限（8.93 ± 1.6 SD），1年内变化很小（0.12 ± 1.34）; MCI受试者的基线DR为6.2 ± 2.2，1年变化为0.20 ± 1.7。我们比较了MCI中ADAS-cog 11和12的标准化变化（变化/SD），发现ADAS-cog 12改善了10%; AD组没有改善。在具有匹配的简易精神状态检查的MCI和AD病例子集中（23 - 27），ADAS-cog 12在MCI受试者的标准化变化方面提供了18%的改善，在AD队列中没有获益，主要是由于方差增加。与ADAS-cog 11相比，将DR添加到ADAS-cog评分中增加了检测MCI受试者1年内变化的能力，但增加了AD受试者的方差，即使是轻度损伤的受试者。这些发现表明，在进行临床试验时，需要针对特定研究人群和诊断量身定制结局指标，以实现最大效率和经济性。
To determine if the addition of delayed recall (DR) assessment adds sensitivity to the cognitive subscale of the Alzheimer Disease Assessment Scale (ADAS-cog) in clinical trials in mild cognitive impairment (MCI) and Alzheimer Disease (AD). Memory, particularly DR, is the most sensitive test for early detection of AD and MCI. However, it is not clear that assessment of DR adds benefit for measuring change over time after a diagnosis is made or in clinical trials. The ADAS-cog is the most commonly used tool to assess treatment efficacy in AD clinical trials. In an attempt to improve sensitivity to change, assessment of DR after the 3-trial, 10-word list was added to the standard 11-item ADAS-cog. We examined the added value of the DR in participants with MCI and AD followed for at least 1 year. Data from 111 subjects with AD and 259 subjects with MCI who were randomly assigned to the placebo arm of 2 clinical trials were included. Participants with AD had Mini- Mental State Examination scores of 13 to 27 and those with MCI had 24 to 30. We calculated the ADAS-cog11 score based on the original 11 items (range: best to worse, 0 to 70), the DR item score (range: 0 to 10 words not recalled), and the ADAS-cog12 (range: 0 to 80). We assessed the rate of missing items for DR over time, the change scores, the association between scores and baseline performance, and used longitudinal mixed effects regression models to examine the rate of change. At baseline AD subjects were near floor on DR (8.93 ± 1.6 SD) and showed little change over 1 year (0.12 ± 1.34); the MCI subjects baseline DR was 6.2 ± 2.2 with 1-year change of 0.20 ± 1.7. We compared standardized change (change/SD) for ADAS-cog11, and 12 in MCI and found a 10% improvement with ADAS-cog12; there was no improvement in the AD group. In a subset of MCI and AD cases with matching Mini-Mental State Examination (23 to 27), the ADAS-cog12 provided an 18% improvement in standardized change in MCI subjects, with no benefit in the AD cohort, primarily owing to increased variance. The addition of DR to the ADAS-cog score increased the ability to detect change in subjects with MCI over 1 year compared with the ADAS-cog11 but increased the variance in subjects with AD, even in those with mild impairment These findings speak to the need to tailor outcome measures to the specific study population and diagnosis for maximal efficiency and economy when conducting clinical trials.