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Recruiting Observational

TAS Test: Online Motor-cognitive Tests for Early Detection of Alzheimer's Disease

NCT05194787 · tracked via the Priya Life Science Australia tracker
Sponsor
University of Tasmania
Phase
Observational
Started
2021-03-05
Last updated
2023-10-30

Condition(s) studied

Alzheimer DiseaseDementiaAge-related Cognitive Decline

Investigational drug(s) / intervention(s)

Cognitive test scores, clinical diagnosis and blood biomarkers

Cognitive test scores, clinical diagnosis and blood biomarkers: Clinical diagnosis of Alzheimer's disease, mild cognitive impairment or normal ageing. Cognitive test score on CANTAB Blood biomarker (p-tau 181) level

Study summary

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.

Eligibility

Sex
ALL
Min age
50 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: \> 50years old Exclusion Criteria: established diagnosis of dementia

Primary outcome measure(s)

  • Develop and validate the optimal TAS Test protocol to detect pre-AD (p-tau 181 positivity) — 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.
  • Prospectively validate TAS Test to predict risks of cognitive decline — 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 — 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.

Trial sites (1)

FacilityCityRegionStatus
University of Tasmania Hobart Tasmania Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05194787 on ClinicalTrials.gov ↗ ← All trials in Australia