Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06339190
Status:
RECRUITING
Last Update Posted:
2024-04-01
First Post:
2023-09-21
Brief Title:
Neurofilament Light Chain And Voice Acoustic Analyses In Dementia Diagnosis
Sponsor:
Monash University
Organization:
Monash University
Study Overview
Official Title:
A Blood Test for Dementia A Cohort Study to Assess the Diagnostic Utility of Plasma Neurofilament Light Chain Protein in All-cause Dementia
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NAVAIDD
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
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
Detailed Description:
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 Alzheimers 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None