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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/NCT06114914
Registration number
NCT06114914
Ethics application status
Date submitted
29/10/2023
Date registered
2/11/2023
Date last updated
14/11/2023
Titles & IDs
Public title
TapTalkTest Project:Development of a Non-invasive Screening Test to Detect Risk of Alzheimer's Disease Pathology
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Scientific title
TapTalkTest: Development of a Non-invasive Screening Test to Detect Risk of Alzheimer's Disease Pathology
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Secondary ID [1]
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UTasmania
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Universal Trial Number (UTN)
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Trial acronym
TapTalkTest
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Alzheimer Disease
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Dementia
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Movement Abnormalities
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Speech Disorders
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Condition category
Condition code
Neurological
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Alzheimer's disease
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Neurological
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Dementias
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Neurological
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Other neurological disorders
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Musculoskeletal
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Other muscular and skeletal disorders
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Mental Health
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Other mental health disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Diagnosis / Prognosis - Tap Talk online program
ISLAND cohort - About 1,000 participants completed hand motor and speech tests online and 150 will attend the research centre for usablity assessments
Clinical - The new app will be tested in about 100 patients at each of the ISLAND Cognitive Clinic or the Royal Hobart Hospital
Diagnosis / Prognosis: Tap Talk online program
Online hand and speech motor testing
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Intervention code [1]
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Diagnosis / Prognosis
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Classification accuracy for blood biomarker of Alzheimer's disease, ptau181 in adults without cognitive symptoms
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Assessment method [1]
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Area under a receiver operating characteristic (ROC) curve - AUC
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Timepoint [1]
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2024
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Primary outcome [2]
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Odds ratio of cognitive decline in adults without cognitive symptoms
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Assessment method [2]
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Mixed effects logistic regression will be used to estimate the odds of a participant being confirmed as 'declining' at time T2 (24 months) conditioned on TapTalk score at time T1 (12 months), where the main measure of cogitive function is the CANTAB paired associate learning (PAL) test.
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Timepoint [2]
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2025
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Primary outcome [3]
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Classification accuracy for prospectively predicting risk of MCI and AD in adults with cognitive symptoms
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Assessment method [3]
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The investigators will calculate AUC for TapTalk and MoCA. 95% confidence intervals will be obtained using bootstrapping. Covariates may include age, gender, APOE4, years of education, and handedness. The investigators will estimate cut-off scores for TapTalk and MoCA to differentiate between cognitively unimpaired vs MCI, and between cognitively unimpaired vs AD using the Youden index to optimise the trade-off between sensitivity and specificity. Classification accuracy (sensitivity and specificity) using these cut-offs will be compared using McNemar's test.
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Timepoint [3]
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2025
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Eligibility
Key inclusion criteria
AIM 1 AND AIM 2 Eligibility criteria
- Adults >50 years old who are participants in the ISLAND Project and who have provided
a blood sample and have normal cognition and no persistent (>3 months) cognitive
symptoms will be eligible.
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Minimum age
50
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- Impaired cognition, defined by a validated cut-off score >1.5 SD above the mean total
errors adjusted for age and gender on the Paired Associates Learning sub-test of
CANTAB.
AIM 3 Eligibility criteria Inclusion Criteria: >3 months of persistent cognitive symptoms
(patient- or family-reported) and >50 years old.
Exclusion criteria: Acutely unwell, significant impairment of hand function, or known
diagnosis of mild cognitive impairment (MCI) or dementia.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2025
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Actual
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Sample size
Target
1000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
TAS
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Recruitment hospital [1]
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University of Tasmania - Hobart
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Recruitment postcode(s) [1]
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7001 - Hobart
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Tasmania
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This project aims to produce a solution for the rising incidence of dementia. This is
particularly pertinent in Tasmania, Australia, with a rapidly ageing population and the
oldest demographics of all Australian states. The team will develop TapTalk, a new screening
test that detects risk of Alzheimer's disease (AD) pathology. TapTalk, will record a person's
hand movements and speech patterns with a smartphone. Computer algorithms will learn which
patterns of data are associated with AD pathology. This innovative test is based on: (i)
emerging research that fine motor control required for hand and speech movements is sensitive
to early AD pathology and (ii) the investigators' new machine learning methods.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT06114914
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Trial related presentations / publications
Alty J, Lawler K, Salmon K, McDonald S, Stuart K, Cleary A, Ma J, Rudd K, Wang X, Chiranakorn-Costa S, Collins J, Merl H, Lin X, Vickers JC. A new one-stop interdisciplinary cognitive clinic model tackles rural health inequality and halves the time to diagnosis: Benchmarked against a national dementia registry. Int J Geriatr Psychiatry. 2023 Aug;38(8):e5988. doi: 10.1002/gps.5988.
Huang G, Li R, Bai Q, Alty J. Multimodal learning of clinically accessible tests to aid diagnosis of neurodegenerative disorders: a scoping review. Health Inf Sci Syst. 2023 Jul 22;11(1):32. doi: 10.1007/s13755-023-00231-0. eCollection 2023 Dec.
Bartlett L, Bindoff A, Doherty K, Kim S, Eccleston C, Kitsos A, Roccati E, Alty J, King AE, Vickers JC. An online, public health framework supporting behaviour change to reduce dementia risk: interim results from the ISLAND study linking ageing and neurodegenerative disease. BMC Public Health. 2023 Sep 29;23(1):1886. doi: 10.1186/s12889-023-16805-2.
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.
Wang X, St George RJ, Bindoff AD, Noyce AJ, Lawler K, Roccati E, Bartlett L, Tran SN, Vickers JC, Bai Q, Alty J. Estimating presymptomatic episodic memory impairment using simple hand movement tests: A cross-sectional study of a large sample of older adults. Alzheimers Dement. 2024 Jan;20(1):173-182. doi: 10.1002/alz.13401. Epub 2023 Jul 30.
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Public notes
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Contacts
Principal investigator
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James Vickers, PhD
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Address
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University of Tasmania
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT06114914
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