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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06339190
Registration number
NCT06339190
Ethics application status
Date submitted
21/09/2023
Date registered
1/04/2024
Titles & IDs
Public title
Neurofilament Light Chain And Voice Acoustic Analyses In Dementia Diagnosis
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Scientific title
A Blood Test for Dementia? A Cohort Study to Assess the Diagnostic Utility of Plasma Neurofilament Light Chain Protein in All-cause Dementia
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Secondary ID [1]
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E21-006-72840
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Universal Trial Number (UTN)
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Trial acronym
NAVAIDD
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Neurodegenerative Diseases
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Dementia
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Condition category
Condition code
Neurological
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Dementias
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Neurological
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Alzheimer's disease
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Neurological
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Neurodegenerative diseases
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Diagnosis / Prognosis - Venepuncture
Diagnosis / Prognosis: Venepuncture
A single blood draw at the time of presentation to clinic or whilst an inpatient.
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Intervention code [1]
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Diagnosis / Prognosis
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Nfl correlation with neurodegeneration
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Assessment method [1]
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Plasma Nfl (pg/ml), estimated using Quanterix SIMOA HD-X
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Timepoint [1]
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Day 0
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Secondary outcome [1]
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Change in speech processing
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Assessment method [1]
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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).
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Timepoint [1]
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Day 0 and 12-months
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Secondary outcome [2]
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Change in language processing
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Assessment method [2]
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Recorded by a member of the research team using Redenlab software and assessed by a speech therapist using Natural Language Processing techniques.
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Timepoint [2]
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Day 0 and at 12-months
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Secondary outcome [3]
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Change in Direct Magnitude Estimation
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Assessment method [3]
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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.
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Timepoint [3]
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Day 0 and at 12-months
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Eligibility
Key inclusion criteria
* All patients presenting to Eastern Health services with a cognitive complaint or potential neurodegenerative disorder
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Individuals not likely to live for 12 months
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2027
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Actual
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Sample size
Target
1000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Box Hill Hospital - Box Hill
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Recruitment hospital [2]
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Wantirna Health - Wantirna
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Recruitment postcode(s) [1]
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3128 - Box Hill
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Recruitment postcode(s) [2]
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3152 - Wantirna
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Funding & Sponsors
Primary sponsor type
Other
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Name
Monash University
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Eastern Health
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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University of Melbourne
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Wake Forest University
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Address [3]
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Country [3]
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Other collaborator category [4]
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Other
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Name [4]
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Deakin University
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Address [4]
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Country [4]
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Other collaborator category [5]
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Other
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Name [5]
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The Florey Institute of Neuroscience and Mental Health
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Address [5]
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Country [5]
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Other collaborator category [6]
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Commercial sector/industry
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Name [6]
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Invitae Corporation
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Address [6]
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Country [6]
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Other collaborator category [7]
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Other
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Name [7]
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Redenlab
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Address [7]
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Country [7]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT06339190
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof. Amy Brodtmann, MBBS, FRACP, PhD, FANZAN
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Address
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Monash University
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Prof. Amy Brodtmann, MBBS, FRACP, PhD, FANZAN
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Address
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Country
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Phone
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03 9094 9540
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06339190