Department of Neurology, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, TX, USA.
Division of Pediatric Neurology, Massachusetts General Hospital, Boston, MA.
J Alzheimers Dis. 2023;92(4):1323-1339. doi: 10.3233/JAD-220934.
Accurately identifying cognitive changes in Mexican American (MA) adults using the Mini-Mental State Examination (MMSE) requires knowledge of population-based norms for the MMSE, a scale which has widespread use in research settings.
To describe the distribution of MMSE scores in a large cohort of MA adults, assess the impact of MMSE requirements on their clinical trial eligibility, and explore which factors are most strongly associated with their MMSE scores.
Visits between 2004-2021 in the Cameron County Hispanic Cohort were analyzed. Eligible participants were ≥18 years old and of Mexican descent. MMSE distributions before and after stratification by age and years of education (YOE) were assessed, as was the proportion of trial-aged (50-85- year-old) participants with MMSE <24, a minimum MMSE cutoff most frequently used in Alzheimer's disease (AD) clinical trials. As a secondary analysis, random forest models were constructed to estimate the relative association of the MMSE with potentially relevant variables.
The mean age of the sample set (n = 3,404) was 44.4 (SD, 16.0) years old and 64.5% female. Median MMSE was 28 (IQR, 28-29). The percentage of trial-aged participants (n = 1,267) with MMSE <24 was 18.6% overall and 54.3% among the subset with 0-4 YOE (n = 230). The five variables most associated with the MMSE in the study sample were education, age, exercise, C-reactive protein, and anxiety.
The minimum MMSE cutoffs in most phase III prodromal-to-mild AD trials would exclude a significant proportion of trial-aged participants in this MA cohort, including over half of those with 0-4 YOE.
使用简易精神状态检查(MMSE)准确识别墨西哥裔美国人(MA)成年人的认知变化需要了解 MMSE 的基于人群的正常值,该量表在研究环境中广泛使用。
描述大量 MA 成年人的 MMSE 评分分布,评估 MMSE 要求对其临床试验资格的影响,并探讨哪些因素与他们的 MMSE 评分最密切相关。
分析 2004-2021 年卡梅伦县西班牙裔队列的就诊情况。合格的参与者年龄在 18 岁以上且为墨西哥裔。评估了按年龄和受教育年限(YOE)分层前后的 MMSE 分布情况,以及 MMSE<24 的符合试验年龄(50-85 岁)参与者的比例,这是在阿尔茨海默病(AD)临床试验中最常使用的最小 MMSE 截止值。作为二次分析,构建随机森林模型来估计 MMSE 与潜在相关变量的相对关联。
样本集(n=3404)的平均年龄为 44.4(标准差,16.0)岁,女性占 64.5%。中位数 MMSE 为 28(四分位距,28-29)。符合试验年龄的参与者(n=1267)中 MMSE<24 的百分比总体为 18.6%,而受教育年限为 0-4 年的参与者中这一比例为 54.3%(n=230)。在研究样本中与 MMSE 最相关的五个变量是教育、年龄、运动、C 反应蛋白和焦虑。
在大多数 III 期前驱期至轻度 AD 临床试验中,最小 MMSE 截止值将排除该 MA 队列中相当一部分符合试验年龄的参与者,包括超过一半受教育年限为 0-4 年的参与者。