Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618002032235
Ethics application status
Approved
Date submitted
13/12/2018
Date registered
19/12/2018
Date last updated
21/10/2019
Date data sharing statement initially provided
19/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Magnetic Resonance Imaging (MRI) Biomarker Study: an observational study to assess differential changes that occur in the brains of participants with various neurodegenerative diseases using MRI technology.
Scientific title
Use of advanced magnetic resonance imaging (MRI) technology to improve understanding and diagnosis of the major neurodegenerative diseases.
Secondary ID [1] 296851 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's disease [AD] 310757 0
Frontotemporal dementia [FTD]
 310833 0
Parkinson's disease [PD]
 310834 0
motor neuron disease [ALS]
310835 0
progressive supranuclear palsy [PSP]
 310836 0
corticobasal degeneration [CBD] 310837 0
Dementia with Lewy Bodies 310838 0
Condition category
Condition code
Neurological 309449 309449 0 0
Neurodegenerative diseases
Neurological 309509 309509 0 0
Alzheimer's disease
Neurological 309510 309510 0 0
Parkinson's disease
Neurological 309511 309511 0 0
Dementias

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Two Magnetic Resonance Imaging (MRI) scans: 3 Tesla (T) and 7T scans by a qualified radiographer at the Centre for Advanced Imaging, University of Queensland.

-Approximately 30-45 minutes of acquisition time each scan.
-3T and 7T scans can be done on a separate visit if required.

Cognitive assessments, such as ACE III, MMSE, RAVLT, and/or SYDBAT will be conducted prior to MRI scans.
Intervention code [1] 313131 0
Not applicable
Comparator / control treatment
Healthy age matched participants

Study procedures will be the same across all participants.

Patient groups will be compared against healthy individuals with no diagnosed neurodegenerative diseases.

Control group
Active

Outcomes
Primary outcome [1] 308417 0
Exploratory Outcome
Disease specific pathological patterns in the potential areas of interest (Putamen, substantia nigra, dentate, motor cortex, red nucleus, and pallidum) using QSM and DTI techniques.

Timepoint [1] 308417 0
Single time point
Secondary outcome [1] 354919 0
Exploratory Outcome
Results from 7 Tesla MRI will provide more detailed information of brain tissue changes.

We expect to reveal further disease specific pathological patterns by measuring (i) changes brain tissue iron deposition in defined brain areas, (ii) volume changes of hippocampal sub-fields, and (iii) changes of tissue micro structure in the corpus callosum,
Timepoint [1] 354919 0
Single time point

Eligibility
Key inclusion criteria
o Visual and auditory acuity, adequate for neuropsychological testing
o English language proficiency, adequate for comprehensive neuropsychological testing
o Willing to undergo repeated MRIs (3T and 7T MRIs)
o Healthy control: without any history of neurological or major psychiatric illness; and who are free of any cognitive symptoms (e.g. Mini Mental State Exam (MMSE) score greater than or equal to 26/30, Addenbrooke’s Cognitive Examination (ACE) score greater than or equal to 88/100, Clinical Dementia Rating (CDR) equal to 0 ) ; and whose general health is good enough to lie comfortably in an MRI scanner (e.g. does not have severe arthritis or breathlessness etc.)
o Patients group will be divided into 7 different subgroups based on their clinical diagnosis.*
o Patient Group 1: Alzheimer’s disease (AD), including prodromal states such as mild cognitive impairment
o Patient Group 2: Parkinson’s disease (PD) patients
o Patient Group 3: Dementia with Lewy Bodies (DLB)
o Patient Group 4: Frontotemporal dementia (FTD)
o Patient Group 5: Progressive supranuclear palsy (PSP)
o Patient Group 6: Corticobasal degeneration (CBD), including patients with undifferentiated akinetic/rigid syndromes, i.e. where the assessing neurologist is confident of a degenerative disease but where the clinical features preclude a more precise diagnosis such as PD, PSP, CBD
o Patient Group 7: Amyotrophic lateral sclerosis (ALS)
o * Diagnosis will be based on patient and carer interview & questionnaire, physical examination, brain scans, cognitive tests (MMSE, ACE, CDR) and/or motor function tests (ALS functional rating scale revised (ALSFRS-R), Unified Parkinson’s disease rating scale (UPDRS), Hoen and Yahr).
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
o Pregnancy#
o Known history of claustrophobia#
o Contra-indication to MRI#: cardiac pacemakers, aneurysm clips, metal implants, hearing aid/implant, electrical neurostimulators, joint replacement etc. in accordance with the standard operating procedures of the Centre for Advanced Imaging, UQ. #NOTE: Participants will be re-interviewed by a radiographer on the day of imaging at the Centre for Advanced Imaging, UQ.
o History of other neurological diseases (including clinical stroke, multiple sclerosis, tumour, epilepsy, or any other disease) that could confound interpretation of the MRI scan data
o History of major psychiatric illness (psychosis, major depression)
o Any medical condition that could make scanning hazardous/uncomfortable (e.g. difficulty lying flat due to cardiac, respiratory or rheumatological disease)
o For the patient group only
o Unavailability of a close relative/companion who can assist the patient to attend the research facility.
o Advanced cognitive impairment rendering the patient untestable on neuropsychological tests or unable to follow the instructions for MRI scanning.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/02/2019
Actual
31/08/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
15
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 301423 0
University
Name [1] 301423 0
University of Queensland
Country [1] 301423 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
Queensland Brain Institute

The University of Queensland
St. Lucia
QLD4072
Country
Australia
Secondary sponsor category [1] 301101 0
None
Name [1] 301101 0
Address [1] 301101 0
Country [1] 301101 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302156 0
The Mater Misericordiae Ltd Human Research Ethics Committee (MML HREC) (EC00332)
Ethics committee address [1] 302156 0
Ethics committee country [1] 302156 0
Australia
Date submitted for ethics approval [1] 302156 0
Approval date [1] 302156 0
10/12/2018
Ethics approval number [1] 302156 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89318 0
Prof Peter Nestor
Address 89318 0
Queensland Brain Institute (Building 79)
The University of Queensland
St. Lucia, QLD 4072
Country 89318 0
Australia
Phone 89318 0
+61 (07) 3346 6389
Fax 89318 0
Email 89318 0
[email protected]
Contact person for public queries
Name 89319 0
Soo Lee
Address 89319 0
Queensland Brain Institute (Building 79)
The University of Queensland
St. Lucia, QLD 4072
Country 89319 0
Australia
Phone 89319 0
+61 (07) 3443 2615
Fax 89319 0
Email 89319 0
[email protected]
Contact person for scientific queries
Name 89320 0
Peter Nestor
Address 89320 0
Queensland Brain Institute (Building 79)
The University of Queensland
St. Lucia, QLD 4072
Country 89320 0
Australia
Phone 89320 0
+61 (07) 3346 6389
Fax 89320 0
Email 89320 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
3T and 7T raw imaging data
de-identified medical record
When will data be available (start and end dates)?
start: Immediately following publication
end: no end date determined
Available to whom?
researchers who provide a methodologically sound proposal
researchers who have their study approved by a Human Research Ethics Committee
Available for what types of analyses?
any research purpose
How or where can data be obtained?
access subject to approvals by Principal Investigator
arrangements for material held in other locations and the use of that materials may be documented and negotiated


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.