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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06339190
Other study ID # E21-006-72840
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 1, 2021
Est. completion date December 2027

Study information

Verified date December 2023
Source Monash University
Contact Prof. Amy Brodtmann, MBBS, FRACP, PhD, FANZAN
Phone 03 9094 9540
Email amy.brodtmann@monash.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 Alzheimer's 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date December 2027
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - All patients presenting to Eastern Health services with a cognitive complaint or potential neurodegenerative disorder Exclusion Criteria: - Individuals not likely to live for 12 months

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Australia Box Hill Hospital Box Hill Victoria
Australia Wantirna Health Wantirna Victoria

Sponsors (8)

Lead Sponsor Collaborator
Monash University Deakin University, Eastern Health, Invitae Corporation, Redenlab, The Florey Institute of Neuroscience and Mental Health, University of Melbourne, Wake Forest University

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Other 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. Day 0 and at 12-months
Other 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. At 12-months
Other 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). At 12-months
Other 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). At 12-months
Other WHO Disability Assessment 12-item telephone interview score Functional screen, staff administered via telephone. Scored as an overall percentage (%) disability, higher scores indicating less function. At 12-months
Other WHO Disability Assessment 36-item self report score Functional screen, self administered. Scored as an overall percentage (%) disability, higher scores indicating less function. At 12-months
Other DNA sample for testing known pathogenic dementia mutations Self-administered saliva sample; Testing using Invitae Fronto-temporal dementia and AD panel: xxxxx Anytime before 12-months
Primary Nfl correlation with neurodegeneration Plasma Nfl (pg/ml), estimated using Quanterix SIMOA HD-X Day 0
Secondary 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). Day 0 and 12-months
Secondary 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. Day 0 and at 12-months
Secondary 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. Day 0 and at 12-months
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