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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
TapTalkTest: Development of a Non-invasive Screening Test to Detect Risk of Alzheimer's Disease Pathology
Secondary ID [1] 0 0
UTasmania
Universal Trial Number (UTN)
Trial acronym
TapTalkTest
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer Disease 0 0
Dementia 0 0
Movement Abnormalities 0 0
Speech Disorders 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias
Neurological 0 0 0 0
Other neurological disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
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 - 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
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Classification accuracy for blood biomarker of Alzheimer's disease, ptau181 in adults without cognitive symptoms
Timepoint [1] 0 0
2024
Primary outcome [2] 0 0
Odds ratio of cognitive decline in adults without cognitive symptoms
Timepoint [2] 0 0
2025
Primary outcome [3] 0 0
Classification accuracy for prospectively predicting risk of MCI and AD in adults with cognitive symptoms
Timepoint [3] 0 0
2025

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.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

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
1/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
1000
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

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT06114914
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.
Public notes

Contacts
Principal investigator
Name 0 0
James Vickers, PhD
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06114914