Neurofilament Light Chain And Voice Acoustic Analyses In Dementia Diagnosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Venepuncture.
- Who it may be relevant to
- Registry conditions: Neurodegenerative Diseases, Dementia. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Blood Test for Dementia? A Cohort Study to Assess the Diagnostic Utility of Plasma Neurofilament Light Chain Protein in All-cause Dementia
Overview
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.
Detailed description
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.
Interventions
- Diagnostic test Venepuncture
A single blood draw at the time of presentation to clinic or whilst an inpatient.
Primary outcome measures
- Baseline NfL level [Time frame: Day 0]
Secondary outcome measures (3)
- Change in speech processing [Time frame: Day 0 and 12-months]
- Change in language processing [Time frame: Day 0 and at 12-months]
- Change in Direct Magnitude Estimation [Time frame: Day 0 and at 12-months]
Eligibility criteria
Inclusion criteria
- All patients presenting to Eastern Health services with a cognitive complaint or potential neurodegenerative disorder
Exclusion criteria
- Prognosis <12 months
- No cognitive complaint
- Patients not involved within the single healthcare network
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Australia · 2 centers
- Box Hill Hospital — Box Hill
- Wantirna Health — Wantirna
Publications
- Ivanic S, Vogel AP, Chatterjee P, Baird J, Darby D, Werden E, Gao L, Darzins P, Patel SK, Burke I, Morris T, Churilov L, Bice J, Mielke MM, Brodtmann A. Neurofilament light chain and voice acoustics in dementia diagnosis (NAVAIDD): Protocol for a cohort study assessing the real-world diagnostic utility of blood and digital biomarkers in clinical settings. J Alzheimers Dis Rep. 2025 Dec 15;9:254248 PMID 41409494
Identifiers
NCT: NCT06339190 · E21-006-72840