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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
Date last updated
1/04/2024

Titles & IDs
Public title
Neurofilament Light Chain And Voice Acoustic Analyses In Dementia Diagnosis
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
Secondary ID [1] 0 0
E21-006-72840
Universal Trial Number (UTN)
Trial acronym
NAVAIDD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neurodegenerative Diseases 0 0
Dementia 0 0
Condition category
Condition code
Neurological 0 0 0 0
Dementias
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Neurodegenerative diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Nfl correlation with neurodegeneration
Timepoint [1] 0 0
Day 0
Secondary outcome [1] 0 0
Change in speech processing
Timepoint [1] 0 0
Day 0 and 12-months
Secondary outcome [2] 0 0
Change in language processing
Timepoint [2] 0 0
Day 0 and at 12-months
Secondary outcome [3] 0 0
Change in Direct Magnitude Estimation
Timepoint [3] 0 0
Day 0 and at 12-months

Eligibility
Key inclusion criteria
* All patients presenting to Eastern Health services with a cognitive complaint or potential neurodegenerative disorder
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Individuals not likely to live for 12 months

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2027
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [2] 0 0
Wantirna Health - Wantirna
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment postcode(s) [2] 0 0
3152 - Wantirna

Funding & Sponsors
Primary sponsor type
Other
Name
Monash University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Eastern Health
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Melbourne
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Wake Forest University
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Deakin University
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
The Florey Institute of Neuroscience and Mental Health
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Commercial sector/industry
Name [6] 0 0
Invitae Corporation
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Redenlab
Address [7] 0 0
Country [7] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT06339190
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Prof. Amy Brodtmann, MBBS, FRACP, PhD, FANZAN
Address 0 0
Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Prof. Amy Brodtmann, MBBS, FRACP, PhD, FANZAN
Address 0 0
Country 0 0
Phone 0 0
03 9094 9540
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06339190