Challenging Assumptions About African American Participation in Alzheimer Disease Trials.
Challenging Assumptions About African American Participation in Alzheimer Disease Trials.
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DOI：
10.1016/j.jagp.2017.04.013
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发表时间：
2017-10
期刊：
影响因子：
--
通讯作者：
Schneider LS
中科院分区：
文献类型：
--
作者：
Kennedy RE;Cutter GR;Wang G;Schneider LS
我们通过检查影响试验设计的共病状况和治疗结果的差异，研究了增加非裔美国人参与阿尔茨海默病 (AD) 和轻度认知障碍 (MCI) 临床试验的潜在影响。使用来自阿尔茨海默病合作研究和阿尔茨海默病神经影像计划的 18 项研究的元数据库，我们纳入了 5,164 名受试者的队列，这些受试者有基线人口统计数据和共病疾病信息，并按器官系统分组。我们使用荟萃分析来比较不同种族的合并症患病率、退出率以及阿尔茨海默病评估量表 (ADAS-cog) 的变化率。我们还模拟了与最近的治疗试验类似的临床试验场景，以确定增加非裔美国人参与对统计功效的影响。大约 7% 的 AD、4% 的 MCI 和 11% 的正常参与者是非裔美国人。与白人相比，非洲裔美国人受试者心血管疾病的患病率较高（比值比 [OR] 2.10，95% 置信区间 [CI] 1.71, 2.57），辍学率较高（OR 1.60，95% CI 1.15, 2.21），但其他疾病的发生率较低。不同种族的进展率（−0.862 点/年，95% CI -1.89，0.162）没有显着差异，并且在样本量与当前 AD 试验设计相似的模拟试验中对功效影响不大。增加非裔美国人对 AD 临床试验的参与将需要调整试验方案以解决合并症和退出问题。然而，多样性的增加不太可能对试验结果产生负面影响，应鼓励增加多样性以促进试验结果的普遍性。
We investigated potential effects of increased African American participation in Alzheimer’s disease (AD) and mild cognitive impairment (MCI) clinical trials by examining differences in comorbid conditions and treatment outcome affecting trial design. Using a meta-database of 18 studies from the Alzheimer’s Disease Cooperative Study and the Alzheimer’s Disease Neuroimaging Initiative, we included a cohort of 5,164 subjects for whom there were baseline demographic data and information on comorbid disorders, grouped by organ system. We used meta-analysis to compare prevalence of comorbidities, dropouts, and rates of change on the Alzheimer’s Disease Assessment Scale (ADAS-cog) by race. We also simulated clinical trial scenarios similar to recent therapeutic trials to determine effects of increased African American participation on statistical power. Approximately 7% of AD, 4% of MCI, and 11% of normal participants were African American. African American subjects had higher prevalence of cardiovascular disorders (odds ratio [OR] 2.10, 95% confidence interval [CI] 1.71, 2.57) and higher rate of dropouts (OR 1.60, 95% CI 1.15, 2.21) compared to whites, but lower rates of other disorders. There were no significant differences in rate of progression (−0.862 points/year, 95% CI −1.89, 0.162) by race, and little effect on power in simulated trials with sample sizes similar to current AD trial designs. Increasing African American participation in AD clinical trials will require adaptation of trial protocols to address comorbidities and dropouts. However, increased diversity is unlikely to negatively affect trial outcomes and should be encouraged to promote generalizability of trial results.
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影响因子：
158.5
作者：
Petersen, RC;Thomas, RG;Thal, LJ
通讯作者：
Thal, LJ
影响因子：
2.1
作者：
Koss, E;Peterson, B;Fillenbaum, GG
通讯作者：
Fillenbaum, GG
影响因子：
14
作者：
Schneider, Lon S.;Kennedy, Richard E.;Cutter, Gary R.
通讯作者：
Cutter, Gary R.
DOI：
10.1097/01.wad.0000190808.97878.b8
发表时间：
2005-10-01
影响因子：
2.1
作者：
Schneider, LS
通讯作者：
Schneider, LS
影响因子：
2.1
作者：
Shadlen, MF;McCormick, WC;Larson, EB
通讯作者：
Larson, EB