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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

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
Trial website
Trial related presentations / publications
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
Deidentified hand and speech motor data with comparative cognitive test scores and diagnoses.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06114914