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临床试验/NCT05194787
NCT05194787招募中不适用

TAS Test: Determining the Feasibility and Validity of Online Motor-cognitive Testing for Early Detection of Alzheimer's Disease

University of Tasmania1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2021年3月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
3,000
试验地点
1
主要终点
Prospectively validate TAS Test to predict risks of cognitive decline

研究概览

简要总结

Global dementia prevalence is rising. Alzheimer's disease (AD), the most common cause, has devastating effects on people's quality of life. AD has a preclinical (pre-AD) period of 10-20 years when brain pathology silently progresses before any cognitive symptoms appear. Current tests for pre-AD are invasive, costly and unsuitable for screening at population level. Similar to screening for pre-diabetes and carcinoma in situ, it is important to detect AD at the preclinical stage in order to offer early interventions before the pathology progresses to the irrerversible degenerative stage. In the study, research will develop a new scalable test (TAS Test) by combining two innovative ideas: hand-movement tests to detect pre-AD >10 years before cognitive symptoms begin; and computer vision so people can "self-test" online using home computers. This unique approach builds on recent discoveries that hand-movement patterns change in pre-AD. The research team will use exquisitely precise computer vision methods to automatically analyse movement data from thousands of participants, and combine this with machine learning of overall motor-cognitive performance. The project team has access to 3 well-phenotyped cohorts, >10,000 existing participants and a cutting-edge assay for a blood AD biomarker, ptau181. The research team will develop a TAS Test algorithm to classify hand-movement and cognitive test data for pre-AD risk (p-taua181 levels) and determine TAS Test's precision to prospectively predict 5-year risks of cognitive decline and AD.

详细描述

Sub-study 1: Cross-sectional study design: From two established cohorts with pre-existing datasets of up to 10 years of longitudinal cognitive, genetic and demographic data, the team will recruit 500 participants over 50 years old who are confirmed to have normal cognition. At baseline and months 3 and 6, the participants will be invited to complete TAS Test online at home, or in the research centre if preferred. The participants will also have a baseline blood test for ptau181 levels (and APOE4 if required). The research team will integrate movement data to develop a multivariable model that discriminates between pre-AD (positive p-tau181) and normal cognitive ageing (negative p-tau181).

Sub-study 2: Prospective 5-year cohort study design: The researchers will invite 10,000 adults from an established long-term (ISLAND Project) cohort to complete online tests at home: (i) TAS Test every 6 months, and (ii) Cambridge Neuropsychological Test Automated Battery (CANTAB) cognitive tests every 24 months. The prospective 'high risk' predictions of TAS Test at baseline will be validated against CANTAB scores, and also clinically (face to face gold standard consensus diagnosis of AD vs MCI vs normal) in a subsample of 300.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • > 50years old

排除标准

  • established diagnosis of dementia

结局指标

主要结局

Prospectively validate TAS Test to predict risks of cognitive decline

时间窗: 5 years

Assess the sensitivity and specificity of TAS Test to predict cognitive trajectories (CANTAB scores) "stable" and "declining" using ROC curve analysis.

Prospectively validate TAS Test to predict risks of AD diagnosis

时间窗: 5 years

Multinomial logistic regression will estimate the (covariate adjusted) log-odds of being in each diagnostic category (AD, MCI and normal) at 5 years as predicted by baseline TAS Test results.

Develop and validate the optimal TAS Test protocol to detect pre-AD (p-tau 181 positivity)

时间窗: 3 years

Receiver Operating Characteristic (ROC) curves will be plotted against the positive p-tau181 cut-off to assess the sensitivity/specificity of TAS Test models to identify the pre-AD stage.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jane Alty

Associate Professor of Neurology

University of Tasmania

研究点 (1)

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