None listed
Conditions
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.
Interventions
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 t
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.
Sponsors
The University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
Yes
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
Exclusion criteria
Patient or ‘support person’ unable or unwilling to participate
Outcome results
None listed