Alzheimer DiseaseTapTalkTestNCT06114914
TapTalkTest Project:Development of a Non-invasive Screening Test to Detect Risk of Alzheimer's Disease Pathology
An observational study of Alzheimer Disease and Dementia, run by University of Tasmania at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Dementia, Movement Abnormalities
- What is being tested?
- Tap Talk online program
- How many people
- 1,000 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Aug 2022to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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)
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TapTalkTest: Development of a Non-invasive Screening Test to Detect Risk of Alzheimer's Disease Pathology
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.
Read the detailed description
This project aims to produce a solution for the rising incidence of dementia. This is particularly pertinent in Tasmania, with a rapidly ageing population. The investigators' will develop TapTalk, a new screening test that detects risk of Alzheimer's disease (AD) pathology. Accounting for 70% of all dementias, the brain pathology of AD progresses silently for more than 10 years before cognitive symptoms emerge (preclinical AD). It is possible to prevent 40% of dementia by modifying risk factors such as physical inactivity and smoking. However, the lack of a cost-effective screening tool means researchers and clinicians cannot target interventions, or recruit to drug trials, in early AD. Currently, cognitive tests lack sensitivity in preclinical AD, and specialist AD biomarker tests are invasive or costly.
The investigators will address the hypothesis: "Hand-speech movement patterns will detect the risk of Alzheimer's disease pathology in research and clinical cohorts" through three aims:
- Develop and validate analytic algorithms for TapTalk by determining which combinations of hand-speech movement data most accurately detect preclinical AD
- Develop smartphone capability for TapTalk and determine usability and validity
- Prospectively validate TapTalk in people who have cognitive symptoms against gold-standard clinical diagnosis of Mild Cognitive Impairment (MCI) and AD dementia
AIM 1 Problem: Identify which combination of hand-speech tests will be most discriminatory.
Method: The investigators will develop software to video-record a 2-minute oral DDK (diadochokinesis) test, where participants make speech-like sounds repetitively e.g. pa-ta-ka. We already have software to collect hand movements (see TAS Test project). The research team will invite 500 ISLAND Project participants (>50 years old) with normal cognition to compete the hand-speech tests. All participants have provided blood samples for p-tau181 levels. This new assay quantifies AD pathology (using our ultrasensitive Simoa analyser) but the practicalities and cost of accessing the highly-specialist analytic equipment limit wide accessibility. We use ptau-181 as this is a highly predictive blood biomarkers of AD risk.
Analysis: The investigators will use deep neural networks to automatically track video key points (e.g. finger/thumb tips) and audio features (e.g. pa-ta-ka). A sliding window approach extracts measures (e.g. speed/rhythm) as input data for developing an algorithm that that classifies p-tau181 levels. Outcome: TapTalk protocol and algorithm.
AIM 2 Problem: Develop smartphone capabilities and age/cognitive status cut-offs Method We will develop a smartphone app. ISLAND Project participants (CANTAB cognitive tests every 24 months in-kind) will be invited to complete TapTalk online every 12 months.
Analysis: Multi-level regression models will measure within-subject variability, and group differences on TapTalk and CANTAB at baseline, 12 and 24 months.
Outcome: An externally validated TapTalk algorithm that produces AD risk scores across age and cognitive ranges.
AIM 3 Problem: Validate TapTalk in people with cognitive symptoms. Method: The clinician researchers working at the Royal Hobart Hospital (RHH) will recruit 100 patients with cognitive symptoms (>3 months) from RHH acute medical/subacute units. The research assistant (RHHF funding requested) will complete a standard cognitive screening tool (MoCA) and smartphone TapTalk then invite patients to attend the new ISLAND cognitive clinic after discharge. This 'one-stop' interdisciplinary clinic provides bulk-billed neuropsychological and geriatrician, neurologist and physiotherapist assessments. The team will also recruit 100 consecutive patients referred to the clinic by their GPs and all patients will complete TapTalk.
Analysis: The accuracy of TapTalk and MoCA will be compared to diagnosis using ROC analysis.
Outcome: TapTalk prospectively clinically validated.
- Conditions
- Alzheimer Disease, Dementia, Movement Abnormalities, Speech Disorders
- Being tested
- Tap Talk online program
- Keywords
- Alzheimer's disease, Dementia, preclinical, Artificial Intelligence, Machine learning
- Medical subject headings
- Alzheimer Disease, Dementia, Movement Disorders, Speech Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tap Talk online programDiagnostic test
Online hand and speech motor testing
| Study group | Role | What they receive |
|---|---|---|
| ISLAND cohort | About 1,000 participants completed hand motor and speech tests online and 150 will attend the research centre for usablity assessments Receives: 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 Receives: Diagnostic Test: Tap Talk online program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Classification accuracy for blood biomarker of Alzheimer's disease, ptau181 in adults without cognitive symptoms
Area under a receiver operating characteristic (ROC) curve - AUC
Measured: 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.
Measured: 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.
Measured: 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start1 Aug 2022
- Primary completion1 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tasmania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jane Alty, University of Tasmania
- Investigators
- James Vickers, PhD, Study director, University of Tasmania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06114914
- Sponsor's protocol ID
- UTasmania
- Acronym
- TapTalkTest
- Status last verified
- Nov 2023
- First submitted
- 29 Oct 2023
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Deidentified hand and speech motor data with comparative cognitive test scores and diagnoses.
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.
PubMed 37592719Huang 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.
PubMed 37489153Bartlett 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.
PubMed 37773122Alty 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.
PubMed 35850660Wang 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.
PubMed 37519032Alty 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.
PubMed 38627686
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TapTalkTest: Development of a Non-invasive Screening Test to Detect Risk of Alzheimer's Disease Pathology
- ClinicalTrials.gov ID
- NCT06114914
- Acronym / sponsor ID
- TapTalkTest / UTasmania
- Conditions
- Alzheimer Disease, Dementia, Movement Abnormalities, Speech Disorders
- Keywords
- Alzheimer's disease, Dementia, preclinical, Artificial Intelligence, Machine learning
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of TasmaniaUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 2 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This project aims to produce a solution for the rising incidence of dementia. This is particularly pertinent in Tasmania, with a rapidly ageing population. The investigators' will develop TapTalk, a new screening test that detects risk of Alzheimer's disease (AD) pathology. Accounting for 70% of all dementias, the brain pathology of AD progresses silently for more than 10 years before cognitive symptoms emerge (preclinical AD). It is possible to prevent 40% of dementia by modifying risk factors such as physical inactivity and smoking. However, the lack of a cost-effective screening tool means researchers and clinicians cannot target interventions, or recruit to drug trials, in early AD. Currently, cognitive tests lack sensitivity in preclinical AD, and specialist AD biomarker tests are invasive or costly.
The investigators will address the hypothesis: "Hand-speech movement patterns will detect the risk of Alzheimer's disease pathology in research and clinical cohorts" through three aims:
- Develop and validate analytic algorithms for TapTalk by determining which combinations of hand-speech movement data most accurately detect preclinical AD
- Develop smartphone capability for TapTalk and determine usability and validity
- Prospectively validate TapTalk in people who have cognitive symptoms against gold-standard clinical diagnosis of Mild Cognitive Impairment (MCI) and AD dementia
AIM 1 Problem: Identify which combination of hand-speech tests will be most discriminatory.
Method: The investigators will develop software to video-record a 2-minute oral DDK (diadochokinesis) test, where participants make speech-like sounds repetitively e.g. pa-ta-ka. We already have software to collect hand movements (see TAS Test project). The research team will invite 500 ISLAND Project participants (>50 years old) with normal cognition to compete the hand-speech tests. All participants have provided blood samples for p-tau181 levels. This new assay quantifies AD pathology (using our ultrasensitive Simoa analyser) but the practicalities and cost of accessing the highly-specialist analytic equipment limit wide accessibility. We use ptau-181 as this is a highly predictive blood biomarkers of AD risk.
Analysis: The investigators will use deep neural networks to automatically track video key points (e.g. finger/thumb tips) and audio features (e.g. pa-ta-ka). A sliding window approach extracts measures (e.g. speed/rhythm) as input data for developing an algorithm that that classifies p-tau181 levels. Outcome: TapTalk protocol and algorithm.
AIM 2 Problem: Develop smartphone capabilities and age/cognitive status cut-offs Method We will develop a smartphone app. ISLAND Project participants (CANTAB cognitive tests every 24 months in-kind) will be invited to complete TapTalk online every 12 months.
Analysis: Multi-level regression models will measure within-subject variability, and group differences on TapTalk and CANTAB at baseline, 12 and 24 months.
Outcome: An externally validated TapTalk algorithm that produces AD risk scores across age and cognitive ranges.
AIM 3 Problem: Validate TapTalk in people with cognitive symptoms. Method: The clinician researchers working at the Royal Hobart Hospital (RHH) will recruit 100 patients with cognitive symptoms (>3 months) from RHH acute medical/subacute units. The research assistant (RHHF funding requested) will complete a standard cognitive screening tool (MoCA) and smartphone TapTalk then invite patients to attend the new ISLAND cognitive clinic after discharge. This 'one-stop' interdisciplinary clinic provides bulk-billed neuropsychological and geriatrician, neurologist and physiotherapist assessments. The team will also recruit 100 consecutive patients referred to the clinic by their GPs and all patients will complete TapTalk.
Analysis: The accuracy of TapTalk and MoCA will be compared to diagnosis using ROC analysis.
Outcome: TapTalk prospectively clinically validated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ISLAND cohort | – | Diagnostic Test: Tap Talk online programAbout 1,000 participants completed hand motor and speech tests online and 150 will attend the research centre for usablity assessments |
| Clinical | – | Diagnostic Test: Tap Talk online programThe new app will be tested in about 100 patients at each of the ISLAND Cognitive Clinic or the Royal Hobart Hospital |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tap Talk online programOnline hand and speech motor testing | Diagnostic test | Clinical, ISLAND cohort |
Primary outcome
Classification accuracy for blood biomarker of Alzheimer's disease, ptau181 in adults without cognitive symptoms
Time frame: 2024
Area under a receiver operating characteristic (ROC) curve - AUC
Odds ratio of cognitive decline in adults without cognitive symptoms
Time frame: 2025
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.
Classification accuracy for prospectively predicting risk of MCI and AD in adults with cognitive symptoms
Time frame: 2025
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Background: PubMed 37592719Alty 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.
- Background: PubMed 37489153Huang 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.
- Background: PubMed 37773122Bartlett 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.
- Background: PubMed 35850660Alty 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.
- Background: PubMed 37519032Wang 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.
- Derived from this study: PubMed 38627686Alty 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.
- ISLAND Project - 10-year prospective cohort study that we will recruit participants from in Aims 1 and 2Link provided by the sponsor.
- ISLAND Clinic - a one-stop cognitive assessment clinic that we will recruit participants from in Aim 3Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Deidentified hand and speech motor data with comparative cognitive test scores and diagnoses.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Vickers, PhD study director
University of Tasmania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Dementia, run by University of Tasmania at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Classification accuracy for blood biomarker of Alzheimer's disease, ptau181 in adults without cognitive symptoms (time frame: 2024). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06114914, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.