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Trial registered on ANZCTR


Registration number
ACTRN12624001059550
Ethics application status
Approved
Date submitted
25/07/2024
Date registered
2/09/2024
Date last updated
2/09/2024
Date data sharing statement initially provided
2/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The Enhanced Dementia Diagnosis (EDD study) study-Evaluating new diagnostics for Alzheimer's Disease against usual care for people attending memory clinics within Australia.
Scientific title
The EDD study-Evaluating new diagnostics for Alzheimer's Disease against usual care for people attending memory clinics within Australia.
Secondary ID [1] 312760 0
None
Universal Trial Number (UTN)
Trial acronym
EDD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 334430 0
Condition category
Condition code
Neurological 331058 331058 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We propose to test the Enhanced Dementia Diagnosis (EDD) program in clinical services in Australia. To participate in this study, people undergoing a diagnostic work up for dementia will donate blood for novel biomarker measurements and undergo a digital cognitive assessment and brain scans. We will collect 2 blood samples of no more than 100ml each. We will complete 2 brain MRIs (30 minutes each), and a single Amyloid PET scan (30-40 minutes) (the PET radiotracer administered intravenously, 200MBq once only). All tests will be conducted by EDD study staff. The EDD program tests will occur on a single day, or over two days, at the research facility (total time <6 h). This will occur, at baseline, and again at 12 months. Completion of these tests will be recorded using study databases to monitor adherence. These diagnostics will be provided to physicians who care for the enrolled patients. The influence of these biomarkers on dementia diagnosis will be assessed. These diagnostics will be collected again at 12 months. Participants (memory clinic doctors, patients and their care partners) will also be requested to complete specific surveys at different timepoints and will be invited to participate in an interview.
Intervention code [1] 329061 0
Diagnosis / Prognosis
Comparator / control treatment
This is a Before and After study…patients are their own control. The usual care process for dementia diagnosis varies between clinical services and varies according to clinical and non-clinical attributes of the patient. Typically, the usual care for dementia diagnosis involves clinical patient assessment, routine blood tests, brain MRI, a traditional neuropsychology assessment and/or FDG-PET conducted over different time-points following referral to a memory clinic. For the EDD study, the EDD program tests will occur in parallel with the dementia diagnosis process under usual care.
Control group
Active

Outcomes
Primary outcome [1] 338828 0
The concordance of a blood biomarker for Alzheimer's disease with a diagnosis of Alzheimer's disease conducted under usual care.
Timepoint [1] 338828 0
The outcome will be assessed at the individual and aggregate level. Baseline blood biomarker testing will be conducted at point of diagnosis, and at 12 months post baseline.
Under usual care, a diagnosis of Alzheimer's disease is typically made within 3-6 months of assessment at a memory clinic.
Primary outcome [2] 338829 0
The concordance of a quantitative brain MRI report for Alzheimer's disease with a diagnosis of Alzheimer's disease conducted under usual care.
Timepoint [2] 338829 0
The outcome will be assessed at the individual and aggregate level. The brain MRI will be conducted at point of diagnosis (baseline), and at 12 months post baseline.
Under usual care, a diagnosis of Alzheimer's disease is typically made within 3-6 months of assessment at a memory clinic.
Primary outcome [3] 338889 0
Concordance of a digital cognitive test with the traditional cognitive test.
Timepoint [3] 338889 0
The outcome will be assessed at the individual and aggregate level. The cognitive test battery will be conducted at point of diagnosis (baseline), and at 12 months post baseline.
Secondary outcome [1] 437803 0
Memory clinic physician acceptability of EDD program
Timepoint [1] 437803 0
The outcome will be assessed at the individual and aggregate level. At point of diagnosis (baseline), single time-point only.
Secondary outcome [2] 438629 0
Patient and / or care partner acceptability of the EDD program
Timepoint [2] 438629 0
At point of diagnosis only.
Secondary outcome [3] 438630 0
Patient and / or care partner acceptability of the EDD program.
Timepoint [3] 438630 0
At point of diagnosis only.

Eligibility
Key inclusion criteria
1) Memory clinic physicians, (2) Memory clinic patients being considered for a diagnosis of Mild Cognitive Impairment or Alzheimer’s disease dementia, and (3) Patients’ care partners.

1) Memory clinic physicians
Specialists (or trainee specialists) who diagnose dementia as part of their usual clinical practice’, private or public.

2) Memory clinic patients
1. Age is greater than or equal to 40 years.
2. Attending a memory clinic seeking assessment for cognitive concerns or dementia.
3. Individuals assessed with dementia have an identified care partner (e.g., family member, spouse, caregiver).

3)Memory clinic patients care partner
An individual, aged over 18, who is nominated as a care partner by the patient.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Memory clinic physicians
Not practicing in an EDD program participating memory clinic.

2) Memory clinic patients
1. Memory clinic physician assesses the patient as unsuitable for dementia diagnostic workup, based on:
a. No evidence of cognitive or behavioural impairment.
b. Potential patient has severe dementia or other illness such that the person will receive no benefit from undergoing further investigation in the opinion of the memory clinic physician.
2. Patient and/or ‘care partner’ is unable or unwilling to provide informed consent for the study.
3. Amyloid pathology status obtained by PET/CSF/Blood are already known to the memory clinic physician.
4. The patient is unable to undergo Aß-PET and FDG-PET.
5. Individuals with advanced care directive that is in potential conflict with consent, for e.g., “I don’t want to be involved in research studies”.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
All participants receive the same treatment and act as their own control with a comparison being made between the Enhanced Dementia Diagnosis program and diagnoses made as part of usual care.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/09/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26809 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment hospital [2] 26845 0
Western Hospital - Footscray - Footscray
Recruitment hospital [3] 26846 0
Barwon Health - McKellar Centre campus - North Geelong
Recruitment hospital [4] 26847 0
Kingston Centre - Cheltenham
Recruitment hospital [5] 26855 0
Ballarat Health Services - Queen Elizabeth Centre - Ballarat
Recruitment postcode(s) [1] 42907 0
3011 - Footscray
Recruitment postcode(s) [2] 42860 0
3081 - Heidelberg West
Recruitment postcode(s) [3] 42909 0
3192 - Cheltenham
Recruitment postcode(s) [4] 42908 0
3215 - North Geelong
Recruitment postcode(s) [5] 42916 0
3350 - Ballarat

Funding & Sponsors
Funding source category [1] 316971 0
Government body
Name [1] 316971 0
NHMRC
Country [1] 316971 0
Australia
Funding source category [2] 316972 0
Government body
Name [2] 316972 0
Australian Department of Health and Aged Care, Medical Research Future Fund (MRFF)
Country [2] 316972 0
Australia
Primary sponsor type
Other
Name
The Florey Institute of Neuroscience and Mental Health
Address
Country
Australia
Secondary sponsor category [1] 319220 0
None
Name [1] 319220 0
Address [1] 319220 0
Country [1] 319220 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315726 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 315726 0
https://www.austin.org.au/Office-for-Research/
Ethics committee country [1] 315726 0
Australia
Date submitted for ethics approval [1] 315726 0
Approval date [1] 315726 0
24/05/2024
Ethics approval number [1] 315726 0
HREC/103365/Austin-2023

Summary
Brief summary
It is difficult for skilled clinicians to diagnose Alzheimer’s disease in the early stages. A diagnosis of Alzheimer’s disease also requires evidence of a particular type of brain pathology by using a specialized brain scan. The EDD study has been devised as a comprehensive solution to address current diagnostic challenges. The EDD study is integrated into existing clinical services, with the aim of providing clinicians with data on pathology, brain damage, and brain function through advanced blood diagnostics, advanced brain-imaging techniques, and in-depth digital cognitive assessments that can be performed via telehealth. This study will assess the accuracy and usefulness of each element of the EDD program using surveys of physicians and patients, and with reference to gold standards.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135614 0
Prof Scott Ayton
Address 135614 0
The Florey, Kenneth Myer Building, Parkville, Victoria, 3010.
Country 135614 0
Australia
Phone 135614 0
+61 0390356559
Fax 135614 0
Email 135614 0
[email protected]
Contact person for public queries
Name 135615 0
Dr Michelle Shannon
Address 135615 0
The Florey, Melbourne Brain Centre, 245 Burgundy Street, Heidelberg, Victoria 3084
Country 135615 0
Australia
Phone 135615 0
+61 0390357079
Fax 135615 0
Email 135615 0
[email protected]
Contact person for scientific queries
Name 135616 0
Scott Ayton
Address 135616 0
The Florey, Kenneth Myer Building, Parkville, Victoria 3010
Country 135616 0
Australia
Phone 135616 0
+61 0390357079
Fax 135616 0
Email 135616 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
For ethical reasons IPD will not be made available


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.