ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Alzheimer's disease [AD]

Frontotemporal dementia [FTD]

Parkinson's disease [PD]

motor neuron disease [ALS]

progressive supranuclear palsy [PSP]

corticobasal degeneration [CBD]

Dementia with Lewy Bodies

Condition category

Condition code

Neurological

Neurodegenerative diseases

Neurological

Alzheimer's disease

Neurological

Parkinson's disease

Neurological

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]

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]

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]

Single time point

Secondary outcome [1]

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]

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

Final

Recruitment in Australia

Recruitment state(s)

QLD

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Queensland

Address [1]

Queensland Brain Institute

The University of Queensland
St. Lucia
QLD4072

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Mater Misericordiae Ltd Human Research Ethics Committee (MML HREC) (EC00332)

Ethics committee address [1]

Level 2 Aubigny Place
Raymond Terrace
South Brisbane QLD 4101

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

10/12/2018

Ethics approval number [1]

Summary

Brief summary

This research project will investigate new markers of altered brain structure in various forms of neurodegenerative diseases using  3 Tesla (3T) Magnetic Resonance Imaging (MRI) as well as more highly sensitive 7 Tesla MRI. 

Each of the neurodegenerative diseases has a characteristic profile (pathology) when the brain is examined under a microscope. Obviously, it is not an option though to remove the brain of a living person for a microscopic examination so we are trying to use MRI brain scans to capture information that could act as indicators for the types of brain pathology that cause these diseases. This is why this project aims to study a range of different degenerative diseases: we predict that the different diseases will be associated with different patterns of change detected with the MRI scans. 

Standard MRI scans such as those used presently in medical practice cannot make precise diagnoses of specific degenerative brain diseases. In fact, one of the main uses of standard clinical MRI is to rule out non-degenerative diseases such as strokes or tumours. Among the different degenerative diseases themselves, however, standard MRI only provides limited information. 

In this study, we will utilise a more powerful scanning technology, such as 7T MRI, to provide ultra-high resolution images. This means that we may be able to detect very small tissue changes in the brains that may have not been revealed previously. 

On the day of MRI scan, participants will be asked to perform some pen and paper tests of their mental abilities (such as memory, thinking, and language) in order to related the scan to their illness stage. MRI scan will take place once these neuropsychological tests are completed. 

We aim, with this research, to develop new types of MRI scans that may give more information about the precise diagnosis of degenerative brain diseases. As well as improving diagnostic accuracy, we also hope this project may identify new information about how these diseases affect the brain.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Peter Nestor

Address

Queensland Brain Institute (Building 79)
The University of Queensland
St. Lucia, QLD 4072

Country

Australia

Phone

+61 (07) 3346 6389

Fax

p.nestor@uq.edu.au

Contact person for public queries

Name

Soo Lee

Address

Queensland Brain Institute (Building 79)
The University of Queensland
St. Lucia, QLD 4072

Country

Australia

Phone

+61 (07) 3443 2615

Fax

soo.lee@uq.edu.au

Contact person for scientific queries

Name

Peter Nestor

Address

Queensland Brain Institute (Building 79)
The University of Queensland
St. Lucia, QLD 4072

Country

Australia

Phone

+61 (07) 3346 6389

Fax

p.nestor@uq.edu.au

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.

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