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美国通过生活方式干预降低风险保护脑健康研究(U.S. POINTER)的基线特征:成功纳入有认知能力下降风险的多样化临床试验队列。

Baseline characteristics of the U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk (U.S. POINTER): Successful enrollment of a diverse clinical trial cohort at risk for cognitive decline.

作者信息

Whitmer Rachel A, Baker Laura D, Carrillo Maria C, Snyder Heather M, Cleveland MaryJo L, Gitelman Darren R, Kivipelto Miia, Leng Xiaoyan I, Lovato Laura, Papp Kathryn V, Pavlik Valory N, Salloway Stephen P, Tangney Christy C, Farias Sarah Tomaszewski, Williamson Jeff D, Wilmoth Sharon, Woolard Nancy, Yu Melissa, Espeland Mark Andrew

机构信息

Department of Public Health Sciences, University of California Davis, Davis, California, USA.

Department of Internal Medicine, Wake Forest University School of Medicine, The Sticht Center for Healthy Aging and Alzheimer's Prevention, -Salem, Winston, North Carolina, USA.

出版信息

Alzheimers Dement. 2025 Jun;21(6):e70351. doi: 10.1002/alz.70351.

DOI:10.1002/alz.70351
PMID:40556311
Abstract

INTRODUCTION

The U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk (U.S. POINTER) is a 2-year randomized controlled trial of two lifestyle interventions in 2111 older adults at increased risk for cognitive decline.

METHODS

Sociodemographic and clinical characteristics and rates of ancillary study participation were described with means and frequencies.

RESULTS

U.S. POINTER successfully enrolled a cohort, ages 60-79 years, which was ethno-racially inclusive (>30% individuals from groups often under-represented in clinical trials with cognitive outcomes) and 18% residing in neighborhoods with moderate or high levels of socioeconomic deprivation. Enrollees were cognitively intact but at increased risk for cognitive decline. Participation in ancillary studies (overall 73%) was uniformly high across sociodemographic groups.

DISCUSSION

The trial cohort meets study goals and provides a basis for assessing multidomain lifestyle intervention effects on cognitive function and other health outcomes that will generalize to large portions of the at-risk US populations.

GOV IDENTIFIER

NCT00017953.

HIGHLIGHTS

The U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk (U.S. POINTER) enrolled individuals at enhanced risk for cognitive decline. Efforts to engage socio-demographically representative individuals were successful. Four ancillary studies with high rate of recruitment extend scientific impact.

摘要

引言

美国通过生活方式干预降低风险保护大脑健康研究(U.S. POINTER)是一项针对2111名认知功能下降风险增加的老年人进行的为期两年的两种生活方式干预随机对照试验。

方法

用均值和频率描述社会人口统计学和临床特征以及辅助研究参与率。

结果

U.S. POINTER成功招募了一个年龄在60 - 79岁的队列,该队列在种族上具有包容性(超过30%来自临床试验中认知结果代表性不足的群体),18%居住在社会经济剥夺程度中等或较高的社区。参与者认知功能正常,但认知功能下降风险增加。各社会人口统计学群体参与辅助研究的比例(总体为73%)均较高。

讨论

该试验队列符合研究目标,为评估多领域生活方式干预对认知功能和其他健康结果的影响提供了基础,这些影响将推广到美国大部分有风险的人群。

政府识别号

NCT00017953。

要点

美国通过生活方式干预降低风险保护大脑健康研究(U.S. POINTER)招募了认知功能下降风险增加的个体。在招募具有社会人口统计学代表性个体方面的努力取得了成功。四项招募率高的辅助研究扩大了科学影响。

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