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NCT Number: NCT06339190

Neurofilament Light Chain And Voice Acoustic Analyses In Dementia Diagnosis

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.

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Key information

Conditions

Neurodegenerative Diseases Alzheimer Disease Behavior Brain Diseases Central Nervous System Diseases Charcot-Marie-Tooth disease, Type 1F Communication Dementia Mental Disorders Nerve Degeneration Nervous System Diseases Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Speech Tauopathies Verbal Behavior

Sex eligibility

All sexes

Study type

Observational

Primary location

Box Hill Hospital, Box Hill, Victoria, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Venepuncture

Diagnostic Test

A single blood draw at the time of presentation to clinic or whilst an inpatient.

Primary outcomes

  1. Baseline NfL level

    Time frame: Day 0

    Plasma Nfl (pg/ml), estimated using Quanterix SIMOA HD-X

Secondary outcomes

  1. Change in speech processing

    Time frame: Day 0 and 12-months

    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).

  2. Change in language processing

    Time frame: Day 0 and at 12-months

    Recorded by a member of the research team using Redenlab software and assessed by a speech therapist using Natural Language Processing techniques.

  3. Change in Direct Magnitude Estimation

    Time frame: Day 0 and at 12-months

    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

  1. Modified Rankin Scale

    Time frame: Day 0 and at 12-months

    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.

  2. Montreal Cognitive Assessment score

    Time frame: At 12-months

    Cognitive screen; staff administered via telephone. Scores include overall MoCA score (0-22) and Memory Index Score (0-15), greater scores indicate greater cognition.

  3. Hospital Anxiety and Depression Scale score

    Time frame: At 12-months

    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).

  4. Clinical Global Impression score

    Time frame: At 12-months

    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).

  5. WHO Disability Assessment 12-item telephone interview score

    Time frame: At 12-months

    Functional screen, staff administered via telephone. Scored as an overall percentage (%) disability, higher scores indicating less function.

  6. WHO Disability Assessment 36-item self report score

    Time frame: At 12-months

    Functional screen, self administered. Scored as an overall percentage (%) disability, higher scores indicating less function.

  7. DNA sample for testing known pathogenic dementia mutations

    Time frame: Anytime before 12-months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Prof. Amy Brodtmann, MBBS, FRACP, PhD, FANZAN

CONTACT

[email protected]

03 9094 9540

Svetlana Ivanic, BSc(Hons)

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Monash University

Other

Collaborators

  • Deakin University
  • Eastern Health
  • Invitae Corporation
  • Redenlab
  • The Florey Institute of Neuroscience and Mental Health
  • University of Melbourne
  • Wake Forest University

Registry information

Official study title

A Blood Test for Dementia? A Cohort Study to Assess the Diagnostic Utility of Plasma Neurofilament Light Chain Protein in All-cause Dementia

Acronym: NAVAIDD

Important dates

Study start
2021
Primary completion
2025
Study completion
2027
First posted
Apr 1, 2024
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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