Trial Review

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
ACTRN12605000015640
Ethics application status
Approved
Date submitted
12/07/2005
Date registered
18/07/2005
Date last updated
18/07/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
The Molecular-Genetic Basis of Behavioural Features in Dementia
Scientific title
The Molecular-Genetic Basis of Behavioural Features in Dementia
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 77 0
Condition category
Condition code
Neurological 94 94 0 0
Dementias

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Genetic studies on Dementia-participants with behavioural disturbance
Intervention code [1] 9 0
Other interventions
Comparator / control treatment
Participants without behavioural disturbance
Control group

Outcomes
Primary outcome [1] 121 0
Identifying genetic associations in Dementia with behavioural symptoms
Timepoint [1] 121 0
Secondary outcome [1] 283 0
Nil
Timepoint [1] 283 0

Eligibility
Key inclusion criteria
1)subjects have Dementia2)subjects have a carer/relative who is a reliable historian3)sujects can be on psychotropic medication
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) subjects have a history of psychosis, significant depression/anxiety, violence prior to developing Dementia2) Subjects have Lew Body Dementia3) Subjects have medical illnesses or are on medications that may cause behavioural disturbance.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 129 0
Self funded/Unfunded
Name [1] 129 0
Country [1] 129 0
Primary sponsor type
Hospital
Name
Royal Brisbane and women's hospital, Queensland University of Technology
Address
Country
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 885 0
Royal Brisbane & Women's Hospital
Ethics committee address [1] 885 0
Ethics committee country [1] 885 0
Australia
Date submitted for ethics approval [1] 885 0
Approval date [1] 885 0
Ethics approval number [1] 885 0

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

Contacts
Principal investigator
Name 35627 0
Address 35627 0
Country 35627 0
Phone 35627 0
Fax 35627 0
Email 35627 0
Contact person for public queries
Name 9198 0
Karen Chau
Address 9198 0
Royal Brisbane & Women's Hospital
Butterfield St
Herston Brisbane QLD 4029
Country 9198 0
Australia
Phone 9198 0
+61 7 36368111
Fax 9198 0
Email 9198 0
[email protected]
Contact person for scientific queries
Name 126 0
Karen Chau
Address 126 0
Royal Brisbane & Women's Hospital
Butterfield St
Herston Brisbane QLD 4029
Country 126 0
Australia
Phone 126 0
+61 7 36368111
Fax 126 0
Email 126 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.