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临床试验/NCT05892952
NCT05892952招募中不适用

IONA Longitudinal Cohort Study

Brain Health Scotland Life Sciences Ltd1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2023年12月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
10,000
试验地点
1
主要终点
(Enhanced Phenotype only) Change over time in cerebrospinal fluid amyloid beta-42

研究概览

简要总结

Understanding more about how diseases that cause dementia develop is critical as the number of people living with, or affected by, dementia in Scotland continues to grow. The IONA Longitudinal Cohort Study (LCS) has been set up to gather information about people's cognitive health (their memory and thinking abilities), their lifestyle and health risk factors for future dementia (such as hearing loss and obesity), genetics and disease biomarkers, over a number of years. The IONA LCS has three main objectives: Firstly to develop this cohort that is well characterised (also known as being "well-phenotyped") that represent the Scottish population (taking into consideration age, sex, ethnicity and education). The second objective is to use this data to build disease models to better understand trajectories of diseases, and identify any sub-populations who have different (i.e. better, worse) disease trajectories. Finally the third objective for IONA LCS is to offer people an optional consent to hear about future studies they may be interested in taking part in.

详细描述

IThe IONA Longitudinal Cohort Study (LCS) will provide a well-phenotyped (combining data on risk factors for dementia, cognitive assessment results, disease biomarkers and genetics) population representative of the Scottish population aged 50 and above across the spectrum of risk for, and the earliest disease stages of, AD dementia and other neurodegenerative conditions. Recent therapeutic successes in the treatment of Mild Cognitive Impairment (MCI) due to Alzheimer's disease (AD) and mild AD, as well as progressions in diagnostic tools such as blood-based biomarkers, has energised the field to develop more specific diagnostics and therapies following the best principles of precision medicine. Large, 'real world' cohorts are needed to understand whether these, and other future breakthroughs, are valid in real world populations away from highly selective clinical trials. Precision medicine requires identification of disease sub-populations who share similar diagnostic profiles that reflect similar disease mechanisms and hence are likely to respond consistently to specific therapeutic interventions. This will require detailed clinical, genetic and biological phenotyping. IONA LCS will recruit uniquely in Scotland and will ensure that a large, diverse, real-world population will be available to drive developments globally of more accurate diagnostics and accelerate the development of new disease modifying therapies.

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
50 Years 至 120 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

(Enhanced Phenotype only) Change over time in cerebrospinal fluid amyloid beta-42

时间窗: 10 years

Change over time on the IONACog (a composite neuropsychological battery)

时间窗: 10 years

(Enhanced Phenotype only) Change over time in cerebrospinal fluid phosphorylated tau 181

时间窗: 10 years

(Enhanced Phenotype only) Change over time in cerebrospinal fluid total tau

时间窗: 10 years

次要结局

  • Change over time in dependency (as measured by the Stern Dependency Scale)(10 years)
  • Change over time in caregiver burden (as measured by the Zarit Burden Index)(10 years)
  • Change over time in quality of life (as measured by the QoL-AD)(10 years)
  • (Enhanced Phenotype only) impact of disclosure of Alzheimer's disease biomarkers as measured by the Impact of Events scale-6.(10 years)

研究者

发起方
Brain Health Scotland Life Sciences Ltd
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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