The Alzheimer's disease assessment scale: Patterns and predictors of baseline cognitive performance in multicenter Alzheimer's disease trials
The Alzheimer's disease assessment scale: Patterns and predictors of baseline cognitive performance in multicenter Alzheimer's disease trials
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DOI：
10.1212/wnl.48.6.1511
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发表时间：
1997-06-01
期刊：
影响因子：
9.9
通讯作者：
Gulanski, B
中科院分区：
文献类型：
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作者：
Doraiswamy, PM;Bieber, F;Gulanski, B
阿尔茨海默病评定量表的认知子量表(ADAS-Cog)被用作阿尔茨海默病(AD)临床药物试验的疗效衡量标准。我们使用了两个相同的26周多中心药物试验中1,648名AD参与者的数据，以检查基线ADAS-Cog分数与选定的人口统计学和临床变量、简易精神状态检查(MMSE)、全球恶化程度量表(GDS)和按亲属评估工具进行老年评估(GERRI)分数的分布。在基线时，平均(+/-SD)MMSE评分为18+/-4，ADAS-Cog评分为28+/-11，大多数受试者处于GDS 4或5期。ADAS-Cog评分与MMSE(R=-0.76，p&t；0.0001)和Gerri(R=0.4，p<；0.0001)总分显著相关。ADAS-COG条目间的相关系数在0.19~0.59之间，均有统计学意义(p<；0.0001)。在多元回归模型中，较年轻的年龄、男性、痴呆发病时的较大年龄、同时使用雌激素和同时使用抗炎药在统计学上显著地与优越的认知表现相关。我们还提供了ADAS-Cog分数与受试者年龄、教育水平、MMSE分数和GDS阶段的分布数据。由于年龄、MMSE评分和GDS分期(而不是ADAS-Cog)通常用于选择AD临床试验的受试者，我们的数据应该会提高赞助商根据所使用的纳入标准预测受试者在试验中的ADAS-Cog评分的能力。我们的数据还表明，年龄、性别、痴呆症发病年龄、教育水平以及(女性)雌激素或抗炎药物的使用与AD的认知能力有关。需要进一步的研究来评估与这些变量相关的认知差异是如何以及何时出现的。
The cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-Cog) is used as an efficacy measure in clinical drug trials of Alzheimer's disease (AD). We used data from 1,648 AD participants in two identical 26-week multicenter drug trials to examine the distribution of baseline ADAS-Cog scores in relation to selected demographic and clinical variables, Mini-Mental State Exam (MMSE), Global Deterioration Scale (GDS), and Geriatric Evaluation by Relative's Rating Instrument (GERRI) scores. At baseline, the mean (+/- SD) MMSE score was 18 +/- 4, the ADAS-Cog score was 28 +/- 11, and most subjects were in GDS stage 4 or 5. The ADAS-Cog score was statistically significantly correlated with MMSE (R = -0.76, p < 0.0001) and GERRI (R = 0.40, p < 0.0001) total scores. Correlations among the ADAS-Cog items ranged from 0.19 to 0.59 and all were statistically significant (p < 0.0001). In a multiple regression model, younger age, male gender, older age at onset of dementia, use of concurrent estrogen, and use of concurrent anti-inflammatory agents were statistically significantly associated with superior cognitive performance. We also present data on the distribution of ADAS-Cog scores in relation to subjects' age, level of education, MMSE score, and GDS stage. Because age, MMSE score, and GDS stage (and not the ADAS-Cog) are commonly used to select subjects for AD clinical trials, our data should improve the ability of sponsors to predict ADAS-Cog scores of the subjects in their trials on the basis of the inclusion criteria used. Our data also suggest that age, gender, age at onset of dementia, level of education, and use of estrogen (in women) or anti-inflammatory drugs are related to cognitive abilities in AD. Further studies are needed to assess how and when cognitive differences related to these variables arise.