About this trial
This cohort study aims to determine if a blood test can aid with diagnosing dementia in anyone presenting with cognitive complaints to a single healthcare network. The investigators will measure levels of a brain protein, Neurofilament light chain (Nfl), and assess changes in language using speech tests.
Participants will have a single blood test and speech test, and will be followed up at 12-months to complete questionnaires and cognitive scales over the phone. The speech test will also be completed again at 12-months.
Individuals at risk of a genetic dementia syndrome will be eligible to complete optional genetic testing involving an 'at home' saliva sample.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All patients presenting to Eastern Health services with a cognitive complaint or potential neurodegenerative disorder
Disqualifiers
Prognosis <12 months
No cognitive complaint
Patients not involved within the single healthcare network
Trial population
The study cohort will include any individual of all ages, ethnicities, identities and genders. This is to ensure that the findings are generalisable to other national healthcare networks and to provide maximum information on the utility of using blood-biomarker estimation in real-world clinical settings
Trial design
Cohort
Prospective
Treatments tested in this trial
Venepuncture
Diagnostic testA single blood draw at the time of presentation to clinic or whilst an inpatient.
Treatment groups
Trial outcomes
Primary outcomes
Baseline NfL level
Plasma Nfl (pg/ml), estimated using Quanterix SIMOA HD-X
Secondary outcomes
Change in speech processing
Staff and/or self administered using Redenlab software and analysed by speech pathologist for acoustic measures of timing (e.g., pause length (seconds) in reading and monologue tasks), vocal control (e.g., fundamental frequency (hertz) and loudness variation (decibel) from vowel and monologue), and vocal quality (e.g., dysphonia measures derived from sustained vowel).
Change in language processing
Recorded by a member of the research team using Redenlab software and assessed by a speech therapist using Natural Language Processing techniques.
Change in Direct Magnitude Estimation
Perceptual rating of speech using Redenlab software; measuring intelligibility (i.e ability to be understood) and naturalness (deviation from healthy norm) of speech. Assessed by a speech therapist on a scale from 0 to 100; 0 indicates none of the speech is intelligible/natural, 100 indicates all the speech is intelligible/natural.
Other outcomes
Modified Rankin Scale
Functional screen; assessed by member of the research team based on clinical notes. Assessed as change from baseline. Scores ranging from 0-5, with higher scores indicating greater disability.
Montreal Cognitive Assessment score
Cognitive screen; staff administered via telephone. Scores include overall MoCA score (0-22) and Memory Index Score (0-15), greater scores indicate greater cognition.
Hospital Anxiety and Depression Scale score
Mood screen; staff administered via telephone. Scores include a total depression score (0-21) and total anxiety score (0-21); grouped according to normal (0-7), Borderline abnormal (8-10) and Abnormal (11-21).
Clinical Global Impression score
Global rating of improvement/change; staff administered via telephone. Scored on a 7 point scale, scores closer to 0 indicative of greater improvement and scores closer to 7 representing much worse).
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Monash University
Lead sponsor
Eastern Health
Collaborator
University of Melbourne
Collaborator
Wake Forest University
Collaborator
Deakin University
Collaborator
The Florey Institute of Neuroscience and Mental Health
Collaborator
Redenlab
Collaborator