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

NCT ID: NCT05194787

Last Updated: 2023-10-30

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 3000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-05
• Study Completion Date: 2030-12-31

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.

Detailed Description

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.

Conditions

Alzheimer Disease; Dementia; Age-related Cognitive Decline

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria: > 50years old

Exclusion Criteria: established diagnosis of dementia

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Health and Medical Research Council, Australia

OTHER

Sponsor Role: collaborator

University of Sydney

OTHER

Sponsor Role: collaborator

University of Leeds

OTHER

Sponsor Role: collaborator

University of Tasmania

OTHER

Sponsor Role: lead

Responsible Party

Jane Alty

Associate Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Prof Vickers, PhD DSc

Role: STUDY_DIRECTOR

University of Tasmania

A/Prof Bai, PhD MSc

Role: PRINCIPAL_INVESTIGATOR

University of Tasmania

Locations

University of Tasmania

Hobart, Tasmania, Australia

Site Status: RECRUITING

Countries

Australia

Central Contacts

A/Prof Alty, MD FRACP

Role: CONTACT

Jane.Alty@utas.edu.au

+61 (0)3 36226 4273

Facility Contacts

A/Prof Alty, MD FRACP

Role: primary

Jane.Alty@utas.edu.au

+61 (0)3 36226 4273

Prof Vickers, PhD DSc

Role: backup

James.Vickers@utas.edu.au

+61 3 6226 4808

References

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.

Reference Type: DERIVED

PMID: 35850660 (View on PubMed)

Other Identifiers

H0021660

Identifier Type: -

Identifier Source: org_study_id