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Trial registered on ANZCTR


Registration number
ACTRN12620001246976
Ethics application status
Approved
Date submitted
17/09/2020
Date registered
20/11/2020
Date last updated
20/11/2020
Date data sharing statement initially provided
20/11/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Monash Cognition Imaging Study (MCIS): Characterising Mild Cognitive Impairment using multimodal biomarkers
Scientific title
Monash Cognition Imaging Study (MCIS): Characterising Mild Cognitive Impairment using multimodal biomarkers
Secondary ID [1] 302339 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild Cognitive Impairment 319111 0
Condition category
Condition code
Neurological 317070 317070 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will undergo a series of clinical and neuroimaging tests and assessments to better understand the cause of their mild cognitive impairment (MCI)
These will include an FDG PET scan (250Mbq, intravenous, one time) 20 min scan duration
Amyloid PET scan (285Mbq, intravenous, one time) 20 min scan duration
A range of cognitive tests - Mini-Mental Status Examination (MMSE); clinical dementia rating scale (CDR); addenbrookes cognitive examination III (ACE-III); weschler menory scale (WMS, 4th edition) visual reproduction subtest; WMS (revised edition) verbal paired associated subtest; weschler adult intelligence scale (4th edition) similarities, digit span, coding and block design subtests; test of premorbid function; controlled oral word association test (COWAT); category fluency test; boston naming test (2nd edition); victoria stroop test; clock drawing test; rey complex figure test, copy trial; hayling test; examination of practice; sentence repetition test and pyramids and palm trees test. These will be conducted over a single administration, testing session expected to last 2-3 hours
MRI (30 min)
A single blood sample for standard laboratory blood tests
A single blood sample for exploratory biomarkers
An optional CSF sample for exploratory biomarkers
Overall study duration will be 3-6 weeks (dependent on the availability of imaging appointments)
Imaging will be performed by qualified and certified nuclear medicine technologists/radiographers.
Cognitive tests will be performed by neuropsychology registrars
Blood sampling will be performed by research nurses
Optional CSF sampling will be performed by anaesthesiologists or neurology fellows
Intervention code [1] 318631 0
Early detection / Screening
Intervention code [2] 318885 0
Diagnosis / Prognosis
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325161 0
The primary outcome will be the patient diagnosis eg Classification of patient cognitive impairment as caused by a specific clinical condition such as Alzheimer's disease or frontotemporal dementia, or a non-neurodegenerative condition such as depression or anxiety.
Patient diagnosis will be determined by the cumulative results of the FDG- and amyloid-PET scans, the MRI and the cognitive test battery. These results will be combined with the clinical assessment by the cognitive neurologist to determine the clinical diagnosis
Timepoint [1] 325161 0
Diagnosis will be made upon completion of study associated assessments.
Secondary outcome [1] 387049 0
Number of patients who are referred to and enrolled in interventional MCI/Alzheimer's Disease/other dementia trials, as determined by review of study database.
Timepoint [1] 387049 0
Every 12 months for the duration of the study (up to 10 years)

Eligibility
Key inclusion criteria
1. Age 30-85 years
2. At least 6 years of education
3. Adequate English, visual & auditory acuity to complete cognitive testing
4. Reliable study partner
5. Subjective and objective cognitive impairment consistent with MCI
6. Potentially interested in participation in therapeutic drug trials
Minimum age
30 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Lifetime history of schizophrenia, schizoaffective disorder, or bipolar disorder.
2. Current major depressive episode or a past history of major depressive disorder with a high risk of relapse in the opinion of the investigator
3. Current drug or alcohol abuse/dependence.
4. History of alcohol abuse/dependence within 2 years of the onset of the symptoms of cognitive impairment.
5. Participants with a history of cancer (other than skin or in situ prostate cancer) within the previous 5 years.
6. Any significant disease or unstable medical condition that could affect cognitive testing or longevity (i.e., chronic renal failure, chronic hepatic disease, severe pulmonary disease).
7. Other neurological illness, including clinically significant stroke or Parkinson’s disease. A history of stable epilepsy is not an exclusion criterion.
8. Participants in whom magnetic resonance imaging (MRI) is contraindicated.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 17550 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 31285 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 306768 0
Commercial sector/Industry
Name [1] 306768 0
Biogen
Address [1] 306768 0
300 Binney Street |
Cambridge,
MA | 02142
Country [1] 306768 0
United States of America
Primary sponsor type
Hospital
Name
Alfred Health
Address
55 Commercial Road
Melbourne 3004
VIC

Country
Australia
Secondary sponsor category [1] 307868 0
None
Name [1] 307868 0
Address [1] 307868 0
Country [1] 307868 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306933 0
Alfred Health HREC
Ethics committee address [1] 306933 0
55 Commercial Road
Melbourne
3004
VIC
Ethics committee country [1] 306933 0
Australia
Date submitted for ethics approval [1] 306933 0
25/06/2020
Approval date [1] 306933 0
03/08/2020
Ethics approval number [1] 306933 0
225/20

Summary
Brief summary
The study will provide a full cognitive assessment of patients with MCI to confirm their diagnosis and likely underlying cause. There are three specific aims of the project:

1. Establish a cohort of well-characterised patients with neurodegenerative diseases presenting as mild cognitive impairment (MCI).
2. Create a repository of blood, brain imaging (MRI & PET) and CSF data for biomarker studies.
3. Implement a clinical model to increase physician referrals to clinical trials, through access to advanced imaging, neurocognitive screening, and cognitive neurologist assessments for people residing in the South Eastern part of Melbourne and rural areas in Victoria.

The study will allow us the opportunity to collect a large database of MCI patients to gain greater insights in to risks, diagnosis and prognosis of the disease. Simultaneously it will provide patients with a clearer understanding of their disease (through use of research only tools) and increase referrals in to clinical trials of potentially beneficial treatments for patients with MCI.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105498 0
Prof Terence O'Brien
Address 105498 0
Level 6 The Alfred Centre
99 Commercial Road
Melbourne
3004 VIC
Country 105498 0
Australia
Phone 105498 0
+61 3 9903 0855
Fax 105498 0
Email 105498 0
te.obrien@alfred.org.au
Contact person for public queries
Name 105499 0
Dr Lucy Vivash
Address 105499 0
Level 6 The Alfred Centre
99 Commercial Road
Melbourne
3004 VIC
Country 105499 0
Australia
Phone 105499 0
+61 3 9903 0860
Fax 105499 0
Email 105499 0
lucy.vivash@monash.edu
Contact person for scientific queries
Name 105500 0
Dr Lucy Vivash
Address 105500 0
Level 6 The Alfred Centre
99 Commercial Road
Melbourne
3004 VIC
Country 105500 0
Australia
Phone 105500 0
+61 3 9903 0860
Fax 105500 0
Email 105500 0
lucy.vivash@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Specifics of data sharing not confirmed presently.
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 9186 0
Study protocol
Citation [1] 9186 0
Link [1] 9186 0
Email [1] 9186 0
lucy.vivash@monash.edu
Other [1] 9186 0
Attachment [1] 9186 0
Summary results
No Results