Neurofilament Light Chain And Voice Acoustic Analyses In Dementia Diagnosis

NCT06339190 | Recruiting

• 1 other identifier: E21-006-72840
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Neurodegenerative Diseases; Dementia

Keywords

Alzheimer's disease; Dementia; Neurofilament light chain; Speech; Neurodegeneration; Biomarker; Health care disparity

Outcome Measures

Primary Outcomes (1)

• Baseline NfL level

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

  Day 0

Secondary Outcomes (3)

• Change in speech processing

  Day 0 and 12-months

• Change in language processing

  Day 0 and at 12-months

• Change in Direct Magnitude Estimation

  Day 0 and at 12-months

Other Outcomes (7)

• Modified Rankin Scale

  Day 0 and at 12-months

• Montreal Cognitive Assessment score

  At 12-months

• Hospital Anxiety and Depression Scale score

  At 12-months

Interventions

Venepuncture DIAGNOSTIC_TEST

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• All patients presenting to Eastern Health services with a cognitive complaint or potential neurodegenerative disorder

You may not qualify if:

• Prognosis \<12 months
• No cognitive complaint
• Patients not involved within the single healthcare network

Sponsors & Collaborators

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

Study Sites (2)

Box Hill Hospital

Box Hill, Victoria, 3128, Australia

RECRUITING

Wantirna Health

Wantirna, Victoria, 3152, Australia

RECRUITING

Related Publications (1)

• 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.

  PMID: 41409494 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be used and processed for plasma and Nfl levels will be quantified using the Quanterix HD-X machine and single molecule array (Simoa). All participants will be offered participation in DNA and plasma banking for future research as an optional part of the study. DNA samples from participants who consent to this optional collection of plasma will contribute to international biobanking initiatives.

MeSH Terms

Conditions

Neurodegenerative Diseases; Dementia; Alzheimer Disease; Charcot-Marie-Tooth disease, Type 1F; Speech; Nerve Degeneration

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Nervous System Diseases; Brain Diseases; Central Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Verbal Behavior; Communication; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

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

  Monash University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

03 9094 9540; amy.brodtmann@monash.edu

Svetlana Ivanic, BSc(Hons)

CONTACT

svetlana.ivanic@monash.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: April 1, 2024
• Study Start: August 1, 2021
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 30, 2025

Record last verified: 2025-05

Locations

AU (2)