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| Name | Class |
|---|---|
| Eastern Health | OTHER |
| University of Melbourne | OTHER |
| Wake Forest University | OTHER |
| Deakin University |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venepuncture | Diagnostic Test | A single blood draw at the time of presentation to clinic or whilst an inpatient. |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline NfL level | Plasma Nfl (pg/ml), estimated using Quanterix SIMOA HD-X | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Montreal Cognitive Assessment score |
Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Prof. Amy Brodtmann, MBBS, FRACP, PhD, FANZAN | Contact | 03 9094 9540 | amy.brodtmann@monash.edu | |
| Svetlana Ivanic, BSc(Hons) | Contact | svetlana.ivanic@monash.edu |
| Name | Affiliation | Role |
|---|---|---|
| Prof. Amy Brodtmann, MBBS, FRACP, PhD, FANZAN | Monash University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Box Hill Hospital | Recruiting | Box Hill | Victoria | 3128 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41409494 | Derived | Ivanic S, Vogel AP, Chatterjee P, Baird J, Darby D, Werden E, Gao L, Darzins P, Patel SK, Burke I, Morris T, Churilov L, Bice J, Mielke MM, Brodtmann A. Neurofilament light chain and voice acoustics in dementia diagnosis (NAVAIDD): Protocol for a cohort study assessing the real-world diagnostic utility of blood and digital biomarkers in clinical settings. J Alzheimers Dis Rep. 2025 Dec 15;9:25424823251395325. doi: 10.1177/25424823251395325. eCollection 2025 Jan-Dec. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 11, 2025 | May 6, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D019636 | Neurodegenerative Diseases |
| D003704 | Dementia |
| D000544 | Alzheimer Disease |
| C537987 | Charcot-Marie-Tooth disease, Type 1F |
| D013060 | Speech |
| D009410 | Nerve Degeneration |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| OTHER |
| The Florey Institute of Neuroscience and Mental Health | OTHER |
| Invitae Corporation | INDUSTRY |
| Redenlab | UNKNOWN |
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Blood samples will be used and processed for plasma and Nfl levels will be quantified using the Quanterix HD-X machine and single molecule array (Simoa).
All participants will be offered participation in DNA and plasma banking for future research as an optional part of the study. DNA samples from participants who consent to this optional collection of plasma will contribute to international biobanking initiatives.
| Day 0 and 12-months |
| 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 |
| 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 |
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| DNA sample for testing known pathogenic dementia mutations | Self-administered saliva sample; Testing using Invitae Fronto-temporal dementia and AD panel: C9orf72, CHCHD10, CHMP2B, DCTN1, FUS, GRN, HNRNPA2B1, MAPT, SQSTM1, TARDBP, TBK1, TREM2, UBQLN2, VCP | Anytime before 12-months |
| Wantirna Health | Recruiting | Wantirna | Victoria | 3152 | Australia |
|
| D001523 | Mental Disorders |
| D024801 | Tauopathies |
| D014705 | Verbal Behavior |
| D003142 | Communication |
| D001519 | Behavior |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |