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临床试验/NCT03687710
NCT03687710Enrolling By Invitation不适用

The Comparative Effectiveness Dementia & Alzheimer's Registry

Weill Medical College of Cornell University1 个研究点 分布在 1 个国家目标入组 452 人开始时间: 2015年2月16日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
452
试验地点
1
主要终点
Change from Baseline in Alzheimer's Prevention Initiative Cognitive Composite (APCC) every 6 months

研究概览

简要总结

To evaluate the effectiveness of using clinical precision medicine to develop lifecourse interventions for Alzheimer's disease (AD) prevention and treatment. Anthropometrics, blood biomarkers (including genetics), and cognition will measured longitudinally to assess the comparative effectiveness of clinical care.

详细描述

The Comparative Effectiveness Dementia & Alzheimer's Registry (CEDAR) Project is a prospective, observational registry of adult patients at-risk for, or with, a diagnosis of dementia due to Alzheimer's disease (AD) or other neurodegenerative dementias. The purpose of this study is to develop a research repository, or database, for information collected during routine medical care of people with normal memory and family history of AD, or with memory loss or other changes in thinking. The registry will help generate empirical evidence that improves knowledge and informs care decisions about risk reduction for dementia due to AD, and about the effectiveness of a clinical precision medicine intervention. Using a life course approach to comparative effectiveness research will enable investigators to analyze the effects of evidence-based multidomain interventions on cognition, biomarkers of AD risk, and calculated AD risk across the pre-dementia spectrum of AD.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years of age or older
  • family history of Alzheimer's disease and no cognitive complaints OR subjective cognitive decline OR preclinical AD OR mild cognitive impairment due to AD or other conditions

排除标准

  • 未提供

结局指标

主要结局

Change from Baseline in Alzheimer's Prevention Initiative Cognitive Composite (APCC) every 6 months

时间窗: every 6 months, for 18 months

Composite Cognitive Battery (including NIH Toolbox Cognition Battery and other pen-and-paper neuropsychological tests).

次要结局

  • Change from Baseline on Multi-Ethnic Study of Atherosclerosis (MESA) Risk Percentage at 18 months.(18 months)
  • Change from Baseline in Homocysteine at 18 months(18 months)
  • Change in Baseline on Cardiovascular Risk Factors, Aging, and Incidence of Dementia (CAIDE) Risk Score at 18 months(18 months)
  • Change from Baseline in Cognitive Aging Composite (CAC) every 6 months(every 6 months, for 18 months)
  • Change from Baseline in Inflammatory Biomarkers at 18 months(18 months)
  • Change from Baseline in Metabolism Biomarkers at 18 months(18 months)
  • Change from Baseline of Australian National University - Alzheimer's Disease Risk Score (ANU-ADRI) at 6 months(6 months)
  • Change from Baseline in Cholesterol Biomarkers at 18 months(18 months)
  • Change from Baseline on American College of Cardiology / American Heart Association Cardiovascular Risk Percentage at 18 months(18 months)
  • Change from Baseline in Vitamin D at 18 months(18 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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