None listed
Conditions
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.
Interventions
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, 200
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.
Sponsors
The Florey Institute of Neuroscience and Mental Health
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No
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.
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”.
Outcome results
None listed