Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611001168943
Ethics application status
Approved
Date submitted
28/10/2011
Date registered
8/11/2011
Date last updated
10/04/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Measuring cognition and brain volume in people with mild cognitive impairment and Alzheimer's disease
Scientific title
Measures of spatial navigation and cholinergic basal forebrain degeneration in older adults with Mild Cognitive Impairment (MCI) and Alzheimer's disease (AD)
Secondary ID [1] 273196 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild Cognitive Impairment 278948 0
Alzheimer's Disease 278949 0
Condition category
Condition code
Neurological 279128 279128 0 0
Other neurological disorders
Neurological 279129 279129 0 0
Alzheimer's disease
Neurological 279250 279250 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participation will include filling out a brief background information sheet and taking part in a clinical/cognitive test battery (Study Part A) and brain imaging (Study Part B).

Clinical/cognitive test battery will take approximately 1 to 1.5 hours to complete and it will include the following:
- Addenbrookes Cognitive Examination
- Computerised spatial navigation task
- Computerised spatial attention task

Brain Imaging will include the Magnetic Resonance Imaging (both structural and diffusion) and it will take a total of 30 minutes to complete.

Participants will be expected to complete these tasks (cognitive/clinical tasks and MRIs) only once, however, they can choose whether they would like to complete them as part of one session or to divide the participation over two sessions.

Further, participants can choose to participate in either Study Part A or Study Part B, or both.

This study will continue until all participants have been tested.
Intervention code [1] 269522 0
Not applicable
Comparator / control treatment
The comparator is the age-matched control group. This group will receive all of the same cognitive/ clinical tests and brain imaging techniques as the clinical group.
Control group
Active

Outcomes
Primary outcome [1] 279771 0
Diagnosis of Mild Cognitive Impairment
Timepoint [1] 279771 0
Following diagnosis
Primary outcome [2] 279772 0
Diagnosis of mild Alzheimer's Disease
Timepoint [2] 279772 0
Following Diagnosis
Secondary outcome [1] 294407 0
Nil
Timepoint [1] 294407 0
Nil

Eligibility
Key inclusion criteria
Diagnosis of Mild Cognitive Impairment or mild Alzheimer's disease
Fluent in written and spoken English
MMSE score should be equal to or greater than 19
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
MMSE score below 19
The eligible participants will be deemed healthy

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 270022 0
Government body
Name [1] 270022 0
National and International Research Alliance Program
Country [1] 270022 0
Australia
Primary sponsor type
University
Name
Queensland Brain Institute, University of Queensland
Address
The Queensland Brain Institute
QBI Building (#79)
Upland Road
The University of Queensland
St Lucia, QLD 4072
Country
Australia
Secondary sponsor category [1] 268998 0
University
Name [1] 268998 0
Centre for Advanced Imaging, University of Queensland
Address [1] 268998 0
The Centre for Advanced Imaging
Gehrmann Laboratory (Building 60)
Research Road
The University of Queensland
St Lucia, QLD, 4072
Country [1] 268998 0
Australia
Other collaborator category [1] 252290 0
Hospital
Name [1] 252290 0
Royal Brisbane and Woman's Hospital
Address [1] 252290 0
Royal Brisbane and Women?s Hospital
Cnr Butterfield St and Bowen Bridge Rd
Herston, QLD, 4029
Country [1] 252290 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271979 0
Royal Brisbane and Women's Hospital Research Ethics Committee
Ethics committee address [1] 271979 0
Ethics committee country [1] 271979 0
Australia
Date submitted for ethics approval [1] 271979 0
20/11/2011
Approval date [1] 271979 0
13/02/2012
Ethics approval number [1] 271979 0
HREC/11/QRBW/466
Ethics committee name [2] 287071 0
The University of Queensland
Behavioural and Social Sciences Ethical Review Committee
Ethics committee address [2] 287071 0
The University of Queensland, St Lucia.
Ethics committee country [2] 287071 0
Australia
Date submitted for ethics approval [2] 287071 0
Approval date [2] 287071 0
02/03/2012
Ethics approval number [2] 287071 0
2012000227

Summary
Brief summary
The overall purpose of this study is to develop magnetic resonance imaging methods to measure degeneration of brain regions and to validate new cognitive tools for early diagnosis of Alzheimer's disease. We expect that people in the control group will perform better on the cognitive tasks than people in the mild cognitive impairment and Alzheimer's disease groups (Part A). We also expect that people's performance on the cognitive tasks will be correlated with their brain volume as measured by the MRI (Part B) and that people's MRI screens will be predictive of Alzheimer's disease diagnosis (Part C).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33259 0
Address 33259 0
Country 33259 0
Phone 33259 0
Fax 33259 0
Email 33259 0
Contact person for public queries
Name 16506 0
Mirela Wagner
Address 16506 0
Queensland Brain Institute
QBI Building (#79)
Upland Road
The University of Queensland
St Lucia, QLD 4072
Country 16506 0
Australia
Phone 16506 0
+61 7 3346 3343
Fax 16506 0
Email 16506 0
[email protected]
Contact person for scientific queries
Name 7434 0
Mirela Wagner
Address 7434 0
Queensland Brain Institute
QBI Building (#79)
Upland Road
The University of Queensland
St Lucia, QLD 4072
Country 7434 0
Australia
Phone 7434 0
+61 7 3346 3343
Fax 7434 0
Email 7434 0
[email protected]

No information has been provided regarding IPD availability


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.