An observational study in Neurodegenerative Diseases and Dementia, sponsored by Monash University. Recruiting at 2 sites in Australia. Per ClinicalTrials.gov, last updated 2025-05-30.
Sponsored by Monash University · Observational
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 Fronto-temporal dementia syndrome will be eligible to complete optional genetic testing involving an 'at home' saliva sample.
Problem: There is no "gold-standard test" to detect all forms of dementia. People can present with subtle changes that are missed on standard cognitive screening tests, which are not designed for people whose first language is not English or from diverse cultural and educational backgrounds. State-of-the art brain imaging is only available to Australians living in large urban centres, further entrenching health care inequities. The lack of validated diagnostic tests and pathways causes diagnostic delays, increases patient and caregiver stress. Therapies are on the horizon for many forms of dementia - not only Alzheimer's disease - meaning that the lack of identification of simple dementia diagnostic biomarkers represents a critical knowledge gap.
Mission: New technologies now allow us to test abnormal brain protein levels in a routine peripheral blood test, record a voice sample to analyse its acoustics and reveal brain disease, and perform "mail-out" genetic tests using a simple saliva sample. The levels of a brain derived blood protein, neurofilament light chain (NfL), will be estimated and natural language processing and acoustic analysis will be measured in all patients presenting with cognitive complaints to a single healthcare network servicing 1 million ethnically and culturally diverse Australians. Researchers will investigate the utility of early genetic testing for those at high risk of a genetic cause for their disease. They will use these data to develop diagnostic pathways, leveraging existing collaborations to develop future screening programs. Early to mid-career researchers will be supported to translate new technologies into clinical practice in the shortest practicable time-frame.
Significance: Accessible and cost effective tests will inform new pathways to dementia diagnosis. This will transform the dementia landscape, shortening time to diagnosis, increasing diagnostic certainty, and allowing more Australians access to appropriate care, education, and future therapies.
2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 250 across 482 observational studies indexed under Dementia.
Browse Dementia studies →Monash University is the lead sponsor of 81 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
A single blood draw at the time of presentation to clinic or whilst an inpatient.
Baseline NfL level
Plasma Nfl (pg/ml), estimated using Quanterix SIMOA HD-X
Time frame: Day 0
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).
Time frame: Day 0 and 12-months
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.
Time frame: Day 0 and at 12-months
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.
Time frame: Day 0 and at 12-months
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.
Time frame: Day 0 and at 12-months
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.
Time frame: At 12-months
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).
Time frame: At 12-months
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).
Time frame: At 12-months
WHO Disability Assessment 12-item telephone interview score
Functional screen, staff administered via telephone. Scored as an overall percentage (%) disability, higher scores indicating less function.
Time frame: At 12-months
WHO Disability Assessment 36-item self report score
Functional screen, self administered. Scored as an overall percentage (%) disability, higher scores indicating less function.
Time frame: At 12-months
DNA sample for testing known pathogenic dementia mutations
Self-administered saliva sample; Testing using Invitae Fronto-temporal dementia and AD panel: C9orf72, CHCHD10, CHMP2B, DCTN1, FUS, GRN, HNRNPA2B1, MAPT, SQSTM1, TARDBP, TBK1, TREM2, UBQLN2, VCP
Time frame: Anytime before 12-months
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided
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