Neurodegenerative DiseasesNAVAIDDNCT06339190
Neurofilament Light Chain And Voice Acoustic Analyses In Dementia Diagnosis
An observational study of Neurodegenerative Diseases and Dementia, run by Monash University at 2 sites in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurodegenerative Diseases, Dementia
- What is being tested?
- Venepuncture
- How many people
- 1,000 participants
- Where
- 2 sitesAustralia
- Study dates
- 1 Aug 2021to Dec 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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
Who may be able to join
- All patients presenting to Eastern Health services with a cognitive complaint or potential neurodegenerative disorder
Who cannot join
- Prognosis <12 months
- No cognitive complaint
- Patients not involved within the single healthcare network
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Svetlana Ivanic, BSc(Hons) contact
Australia2 sites, 2 recruiting
- Recruiting
Box Hill Hospital
Box Hill, Victoria, 3128
Svetlana Ivanic, svetlana.ivanic@monash.edu
- Recruiting
Wantirna Health
Wantirna, Victoria, 3152
Sarah Shue
About this study
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
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.
Read the 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.
- Conditions
- Neurodegenerative Diseases, Dementia
- Being tested
- Venepuncture
- Keywords
- Alzheimer's disease, Dementia, Neurofilament light chain, Speech, Neurodegeneration, Biomarker, Health care disparity
- Medical subject headings
- Neurodegenerative Diseases, Dementia, Alzheimer Disease, Charcot-Marie-Tooth disease, Type 1F, Speech, Nerve Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenepunctureDiagnostic test
A single blood draw at the time of presentation to clinic or whilst an inpatient.
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline NfL level
Plasma Nfl (pg/ml), estimated using Quanterix SIMOA HD-X
Measured: Day 0
Secondary outcomes (3)
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).
Measured: 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.
Measured: 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.
Measured: Day 0 and at 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start1 Aug 2021
- Primary completionMar 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neurodegenerative DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Monash University
- Sponsor type
- University, hospital or other
- Collaborators
- Eastern Health, University of Melbourne, Wake Forest University, Deakin University, The Florey Institute of Neuroscience and Mental Health, Redenlab
- Responsible party
- Principal investigator, Amy Brodtmann, Monash University
- Investigators
- Prof. Amy Brodtmann, MBBS, FRACP, PhD, FANZAN, Principal investigator, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06339190
- Sponsor's protocol ID
- E21-006-72840
- Acronym
- NAVAIDD
- Status last verified
- Oct 2026
- First submitted
- 21 Sep 2023
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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;9:25424823251395325. doi: 10.1177/25424823251395325. eCollection 2025 Jan-Dec.
PubMed 41409494