TapTalkTest Project:Development of a Non-invasive Screening Test to Detect Risk of Alzheimer's Disease Pathology

NCT06114914 | Unknown

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

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.

Conditions

Alzheimer Disease; Dementia; Movement Abnormalities; Speech Disorders

Keywords

Alzheimer's disease; Dementia; preclinical; Artificial Intelligence; Machine learning

Outcome Measures

Primary Outcomes (3)

• Classification accuracy for blood biomarker of Alzheimer's disease, ptau181 in adults without cognitive symptoms

  Area under a receiver operating characteristic (ROC) curve - AUC

  2024

• Odds ratio of cognitive decline in adults without cognitive symptoms

  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.

  2025

• Classification accuracy for prospectively predicting risk of MCI and AD in adults with cognitive symptoms

  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.

  2025

Study Arms (2)

ISLAND cohort

About 1,000 participants completed hand motor and speech tests online and 150 will attend the research centre for usablity assessments

Diagnostic Test: Tap Talk online program

Clinical

The new app will be tested in about 100 patients at each of the ISLAND Cognitive Clinic or the Royal Hobart Hospital

Diagnostic Test: Tap Talk online program

Interventions

Tap Talk online program DIAGNOSTIC_TEST

Online hand and speech motor testing

Clinical; ISLAND cohort

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

AIM 1 \& AIM 2 STUDY POPULATIONS The ISLAND Project (Bartlett et al doi: 10.2196/34688) is a 10-year prospective cohort study of Tasmanians \>50 years old with nested interventions to reduce dementia risk. \>13,000 people have been recruited, 8,500 research participants have provided detailed demographics and health data, 3,000 have completed online CANTAB cognitive tests and 1,500 have provided blood samples. ISLAND surveys are repeated annually, and cognitive tests and blood-based biomarkers are collected every second year. AIM 3 STUDY POPULATION Adults aged \>50 years old who are admitted to the RHH medical wards or referred by their GP to the ISLAND Cognitive clinic (Alty et al doi: 10.1002/gps.5988)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Tasmania: lead

Study Sites (1)

University of Tasmania

Hobart, Tasmania, 7001, Australia

Location

Related Publications (6)

• 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.

  PMID: 37592719 BACKGROUND

• 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.

  PMID: 37489153 BACKGROUND

• 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.

  PMID: 37773122 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 37519032 BACKGROUND

• Alty J, Goldberg LR, Roccati E, Lawler K, Bai Q, Huang G, Bindoff AD, Li R, Wang X, St George RJ, Rudd K, Bartlett L, Collins JM, Aiyede M, Fernando N, Bhagwat A, Giffard J, Salmon K, McDonald S, King AE, Vickers JC. Development of a smartphone screening test for preclinical Alzheimer's disease and validation across the dementia continuum. BMC Neurol. 2024 Apr 16;24(1):127. doi: 10.1186/s12883-024-03609-z.

  PMID: 38627686 DERIVED

Related Links

• ISLAND Project - 10-year prospective cohort study that we will recruit participants from in Aims 1 and 2
• ISLAND Clinic - a one-stop cognitive assessment clinic that we will recruit participants from in Aim 3

Biospecimen

Retention: SAMPLES WITH DNA

ApoE4 genotyping - to be used as a covariate in the analysis

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Movement Disorders; Speech Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• James Vickers, PhD

  University of Tasmania

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: October 29, 2023
• First Posted: November 2, 2023
• Study Start: August 1, 2022
• Primary Completion: June 1, 2025
• Study Completion: December 31, 2025
• Last Updated: November 14, 2023

Record last verified: 2023-11

Locations

AU (1)