Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000515796
Ethics application status
Approved
Date submitted
3/03/2022
Date registered
31/03/2022
Date last updated
6/09/2022
Date data sharing statement initially provided
31/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the impact of blood-based biomarkers on clinician diagnostic confidence and management in a Memory Clinic setting: A before and after study
Scientific title
Implementing blood-based biomarkers into memory clinics: a before and after study evaluating the impact of blood-based biomarkers on clinician diagnostic confidence and management
Secondary ID [1] 306462 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Subjective memory complaints 325310 0
Mild cognitive Impairment 325311 0
Dementia 325312 0
Condition category
Condition code
Neurological 322704 322704 0 0
Neurodegenerative diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
We will recruit a total of 120 participants presenting for a cognitive assessment at a Memory Clinic associated with the Australian Dementia Network. Participation in this study will involve one face-to-face visit which will be integrated into the participant's routine clinical assessment (baseline assessment), but will also include some additional questionnaires.

Clinic visit 1 - Baseline assessment:

Before obtaining written consent, the participant will complete their routine assessment at the Memory Clinic to ensure that they meet eligibility criteria, ensuring that they are competently able to provide consent to participate in the study. This will include, in addition to other tests, completing a short cognitive test known as the Mini-Mental State Examination (MMSE) to confirm their eligibility. If the participant meets the eligibility criteria, their study doctor will ensure that they have fully understood the Participant Information and Consent Form, including having a discussion with them that their blood test result may influence the study doctor's clinical diagnosis and management, explaining any perceived risks that may be associated.

The participant will be asked to complete a new set of questionnaires, which can be sent via mail, or completed via the internet, depending on their preference. These baseline questionnaires will take approximately 25 minutes to complete. The participant’s study partner (i.e. the participant's nominated carer or significant other) will also complete some questionnaires regarding the participant's physical and/or mental health and well-being.

At this visit the participant may be asked to give a blood sample. Where the participant has previously provided a blood sample to the Memory Clinic as part of their routine assessment, we will seek their consent to utilise blood samples previously collected, reducing the need to collect further blood. Where the participant hasn’t provided a blood sample, we will collect a blood sample following consent. The participant does not have to be fasting for this blood test.

This initial component of the study will take between 60 and 90mins.
Intervention code [1] 322892 0
Diagnosis / Prognosis
Intervention code [2] 322893 0
Early detection / Screening
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330506 0
Acceptability as assessed by the percentage of eligible participants agreeing to be in the study within a 6 month recruitment period following an audit of study records
Timepoint [1] 330506 0
Within 6 months from randomisation of the first participant
Primary outcome [2] 330517 0
Feasibility as assessed by clinician experiences indicating barriers and enablers of uptake within the service assessed via questionnaire (study-specific) and semi-structured interview
Timepoint [2] 330517 0
At the conclusion of the study
Secondary outcome [1] 406508 0
Change in management practice as evidenced by a change in the clinician's diagnosis assessed via questionnaire (study-specific)
Timepoint [1] 406508 0
Within one month following communication of the participant's blood-test result
Secondary outcome [2] 406509 0
Change in management practice as evidenced by the clinician's diagnostic confidence rating assessed via questionnaire (study-specific) including Likert scale.
Timepoint [2] 406509 0
Within one month following communication of the participant's blood-test result
Secondary outcome [3] 406510 0
Change in management practice as evidenced by the percentage of clinicians prescribing medications for Alzheimer’s disease vs. other dementias following an audit of study records
Timepoint [3] 406510 0
Within one month following communication of the participant's blood-test result
Secondary outcome [4] 406511 0
Change in management practice as evidenced by clinicians changing their treatment choice following an audit of study records
Timepoint [4] 406511 0
Within one month following communication of the participant's blood-test result
Secondary outcome [5] 406512 0
Change in management practice as evidenced by a clinician's rating of whether the diagnostics were helpful for their clinical practice assessed via questionnaire (study-specific) and semi-structured interview
Timepoint [5] 406512 0
Within one month following communication of the participant's blood-test result
Secondary outcome [6] 406513 0
Change in management practice as evidenced by clinicians prescribing non-pharmacological interventions following an audit of study records
Timepoint [6] 406513 0
Within one month following communication of the participant's blood-test result

Eligibility
Key inclusion criteria
1. Aged 50 years and above
2. Attending a memory clinic seeking assessment for cognitive concerns or dementia
3. MMSE score 23 and above
4. Have an identified ‘support person’ (e.g. family member, spouse, caregiver)
5. In all Australian States where the study is conducted (New South Wales, Victoria and Tasmania), both the participant and ‘support person’ must consent to be involved in the study
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patient or ‘support person’ unable or unwilling to participate

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
This study is predominantly a pilot study to determine overall effect size to fund larger trials. It is estimated there will be 80% power to determine a medium to large effect size with this sample of 120 participants.

Between groups comparisons will be tested using Fisher’s Exact Test when they are proportions and using independent group t-tests or Mann-Whitney U Test, as appropriate.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/09/2022
Actual
Date of last participant enrolment
Anticipated
19/03/2023
Actual
Date of last data collection
Anticipated
19/09/2023
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,TAS,VIC
Recruitment hospital [1] 21774 0
Brain and Mind Centre - University of Sydney - Camperdown
Recruitment hospital [2] 21775 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [3] 21831 0
The ISLAND Clinic - Hobart
Recruitment postcode(s) [1] 36828 0
2050 - Camperdown
Recruitment postcode(s) [2] 36829 0
3084 - Heidelberg
Recruitment postcode(s) [3] 36854 0
7000 - Hobart

Funding & Sponsors
Funding source category [1] 310811 0
Government body
Name [1] 310811 0
National Health and Medical Research Council (NHMRC)
Country [1] 310811 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney, Camperdown, NSW 2006
Country
Australia
Secondary sponsor category [1] 312068 0
None
Name [1] 312068 0
Address [1] 312068 0
Country [1] 312068 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310379 0
Sydney Local Health District Human Research Ethics Committee (RPAH zone)
Ethics committee address [1] 310379 0
Level 11, KGV Building Missenden Road CAMPERDOWN NSW 2050
Ethics committee country [1] 310379 0
Australia
Date submitted for ethics approval [1] 310379 0
16/11/2021
Approval date [1] 310379 0
30/08/2022
Ethics approval number [1] 310379 0

Summary
Brief summary
The slow build-up of two toxic proteins called amyloid and tau, are believed to be the cause of Alzheimer’s disease (AD). Recently, there have been global breakthroughs in the ability of new blood-tests to detect a toxic form of the tau protein implicated in AD pathology (pTau181). It is suggested that a blood-test targeting this protein will improve diagnostic accuracy, particularly in early-disease stages, allowing for the earlier start of treatments. To date, we have yet to determine whether providing such a test result to the treating clinicians of people attending a memory clinic influences clinician diagnostic confidence and management. We aim to address this gap for people attending a Memory Clinic where there is diagnostic uncertainty or mild cognitive impairment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117446 0
Prof Sharon Naismith
Address 117446 0
Level 2 Building G, Brain & Mind Centre 100 Mallet Street, Camperdown NSW 2050 Australia
Country 117446 0
Australia
Phone 117446 0
+61 02 9351 0781
Fax 117446 0
Email 117446 0
sharon.naismith@sydney.edu.au
Contact person for public queries
Name 117447 0
Dr Johannes Michaelian
Address 117447 0
Level 2, Building D17, Charles Perkins Centre Johns Hopkins Drive, Camperdown NSW 2050
Country 117447 0
Australia
Phone 117447 0
+61 02 9351 0621
Fax 117447 0
Email 117447 0
johannes.michaelian@sydney.edu.au
Contact person for scientific queries
Name 117448 0
Prof Sharon Naismith
Address 117448 0
Level 2 Building G, Brain & Mind Centre 100 Mallet Street, Camperdown NSW 2050 Australia
Country 117448 0
Australia
Phone 117448 0
+61 02 9351 0781
Fax 117448 0
Email 117448 0
sharon.naismith@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.