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

NCT05194787 | Recruiting DMC

• 1 other identifier: H0021660
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alzheimer Disease; Dementia; Age-related Cognitive Decline

Keywords

pre-clinical; early detection; online tests; Artificial intelligence

Outcome Measures

Primary Outcomes (3)

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

  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.

  3 years

• Prospectively validate TAS Test to predict risks of cognitive decline

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

  5 years

• Prospectively validate TAS Test to predict risks of AD diagnosis

  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.

  5 years

Interventions

Cognitive test scores, clinical diagnosis and blood biomarkers DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Currently focused on adults aged \> 50 years in established cohort studies in Australia: ie participants from Tasmanian Healthy Brain Project, Healthy Brain and Ageing project or ISLAND Project.

Sponsors & Collaborators

• University of Tasmania: lead
• National Health and Medical Research Council, Australia: collaborator
• University of Sydney: collaborator
• University of Leeds: collaborator

Study Sites (1)

University of Tasmania

Hobart, Tasmania, 7001, Australia

RECRUITING

Related Publications (1)

• Alty J, Bai Q, Li R, Lawler K, St George RJ, Hill E, Bindoff A, Garg S, Wang X, Huang G, Zhang K, Rudd KD, Bartlett L, Goldberg LR, Collins JM, Hinder MR, Naismith SL, Hogg DC, King AE, Vickers JC. The TAS Test project: a prospective longitudinal validation of new online motor-cognitive tests to detect preclinical Alzheimer's disease and estimate 5-year risks of cognitive decline and dementia. BMC Neurol. 2022 Jul 18;22(1):266. doi: 10.1186/s12883-022-02772-5.

  PMID: 35850660 DERIVED

Related Links

• University profile for Principal Investigator

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples for p-tau 181 and APOE4

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Prof Vickers, PhD DSc

  University of Tasmania

  STUDY DIRECTOR

• A/Prof Bai, PhD MSc

  University of Tasmania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

A/Prof Alty, MD FRACP

CONTACT

+61 (0)3 36226 4273; Jane.Alty@utas.edu.au

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: January 18, 2022
• Study Start: March 5, 2021
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2030
• Last Updated: October 30, 2023

Record last verified: 2023-10

Locations

AU (1)