Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05194787




Registration number
NCT05194787
Ethics application status
Date submitted
29/12/2021
Date registered
18/01/2022
Date last updated
30/10/2023

Titles & IDs
Public title
TAS Test: Online Motor-cognitive Tests for Early Detection of Alzheimer's Disease
Scientific title
TAS Test: Determining the Feasibility and Validity of Online Motor-cognitive Testing for Early Detection of Alzheimer's Disease
Secondary ID [1] 0 0
H0021660
Universal Trial Number (UTN)
Trial acronym
TASTest
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer Disease 0 0
Dementia 0 0
Age-related Cognitive Decline 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Diagnosis / Prognosis - Cognitive test scores, clinical diagnosis and blood biomarkers

Diagnosis / Prognosis: 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 code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Develop and validate the optimal TAS Test protocol to detect pre-AD (p-tau 181 positivity)
Timepoint [1] 0 0
3 years
Primary outcome [2] 0 0
Prospectively validate TAS Test to predict risks of cognitive decline
Timepoint [2] 0 0
5 years
Primary outcome [3] 0 0
Prospectively validate TAS Test to predict risks of AD diagnosis
Timepoint [3] 0 0
5 years

Eligibility
Key inclusion criteria
> 50years old
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
established diagnosis of dementia

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/03/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2030
Actual
Sample size
Target
3000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 0 0
University of Tasmania - Hobart
Recruitment postcode(s) [1] 0 0
7001 - Hobart

Funding & Sponsors
Primary sponsor type
Other
Name
University of Tasmania
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Sydney
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
University of Leeds
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05194787
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Prof Vickers, PhD DSc
Address 0 0
University of Tasmania
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
A/Prof Alty, MD FRACP
Address 0 0
Country 0 0
Phone 0 0
+61 (0)3 36226 4273
Fax 0 0
Email 0 0
Jane.Alty@utas.edu.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05194787