Neurofilament Light Chain And Voice Acoustic Analyses In Dementia Diagnosis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMonash University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Prognosis <12 months

No cognitive complaint

Patients not involved within the single healthcare network

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Venepuncture

    Diagnostic test

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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Baseline NfL level

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

Time frame
Day 0

Secondary outcomes

1

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
2

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
3

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

Other outcomes

1

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
2

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
3

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
4

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Monash University

Lead sponsor

Eastern Health

Collaborator

University of Melbourne

Collaborator

Wake Forest University

Collaborator

Deakin University

Collaborator

The Florey Institute of Neuroscience and Mental Health

Collaborator

Redenlab

Collaborator