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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.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
ACTRN12610000090011
Ethics application status
Approved
Date submitted
22/01/2010
Date registered
27/01/2010
Date last updated
27/01/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Nutrigenomic risk profiles for Mild Cognitive Impairment, Alzheimer's disease and Parkinson's disease
Scientific title
Nutrigenomic risk profiles for Mild Cognitive Impairment, Alzheimer's disease and Parkinson's disease
Secondary ID [1] 1332 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neurodegenerative diseases 256656 0
Condition category
Condition code
Neurological 256793 256793 0 0
Neurodegenerative diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Using cytokinesis block micronucleus cytome assay to identify cell genome damage biomarkers for mild cognitive impairment, Alzheimer's disease, and Parkinson's disease. This study will take place for 2 years.
Intervention code [1] 255866 0
Not applicable
Comparator / control treatment
Inclusion criteria:Male or female, aged 55 and above, not clinically diagnosed with mild cognitive impairment, Alzheimer's disease and Parkinson's disease, no family history of mild cognitive impairment, Alzheimer's disease and Parkinson's disease

Exclusion criteria:Patients who are undergoing chemotherapy/radiotherapy treatment for cancer, patients who are supplementing with above recommended dietary intakes of micronutrients associated with genome maintenance
Control group
Active

Outcomes
Primary outcome [1] 257678 0
Determine the potential biomarkers for those who are at increased risk of mild cognitive impairment, Alzheimer's disease and Parkinson's disease by using cytokinesis block micronucleus assay.
Timepoint [1] 257678 0
Only one timepoint, data analysed at end of trial.
Secondary outcome [1] 262994 0
Define nutrigenomic risk profiles for mild cognitive impairment, Alzheimer's disease and Parkinson's disease using blood analysis
Timepoint [1] 262994 0
Only one timepoint, data analysed at end of trial.

Eligibility
Key inclusion criteria
Control Group:
Male or female, Aged 55 and above, Not clinically diagnosed with mild cognitive impairment, Alzheimer's disease and Parkinson's, No family history of mild cognitive impairment, Alzheimer's disease and Parkinson's disease
Mild cognitive impairment Group:
Male or female, Aged 55 and above, Clinically diagnosed with mild cognitive impairment
Alzheimer's disease Group:
Male or female, Aged 55 and above, Clinically diagnosed with Alzheimer's disease
Parkinson's disease Group:
Male or female, Aged 55 or above, Clinically diagnosed with Parkinson's disease
Minimum age
55 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Control Group:
Patients who are undergoing chemotherapy,radiotherapy treatment for cancer, patients that are supplementing with above recommended dietary intakes of micronutrients associated with genome maintenance
Mild cognitive impairment Group:
Patients who are undergoing chemotherapy, radiotherapy treatment for cancer, patients that are supplementing with above recommended dietary intakes of micronutrients associated with genome maintenance
Alzheimer's disease Group:
Patients who are undergoing chemotherapy, radiotherapy treatment for cancer, patients that are supplementing with above recommended dietary intakes of micronutrients associated with genome maintenance
Parkinson's disease Group:
Patients who are undergoing chemotherapy, radiotherapy treatment for cancer, patients that are supplementing with above recommended dietary intakes of micronutrients associated with genome maintenance

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
900
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256378 0
Government body
Name [1] 256378 0
Commonwealth Scientific and Industrial Research Organisation
Country [1] 256378 0
Australia
Primary sponsor type
Government body
Name
Commonwealth Scientific and Industrial Research Organisation
Address
Gate 13, Commonwealth Scientific and Industrial Research Organisation, Kintore Avenue, Adelaide 5000
Country
Australia
Secondary sponsor category [1] 251690 0
None
Name [1] 251690 0
Address [1] 251690 0
Country [1] 251690 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The incidence of neurodegenerative diseases such as Alzheimer’s (AD) and Parkinson’s (PD) disease are expected to rise in the next 30 years as a result of Australia’s ageing population.
However, conclusive diagnostic tests and impact of dietary status for neurodegenerative disease risk are not clearly defined. Therefore, it is important to identify potential genome damage biomarkers and micronutrients associated with these diseases that may aid in the design of potential preventative measures. The hypothesis is mild cognitive impairment, Alzheimer’s disease, and Parkinson’s disease exhibit increases in genome damage and cell death biomarkers relative to each other, and to healthy age matched controls.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30733 0
Address 30733 0
Country 30733 0
Phone 30733 0
Fax 30733 0
Email 30733 0
Contact person for public queries
Name 13980 0
Professor Michael Fenech
Address 13980 0
Gate 13, Commonwealth Scientific and Industrial Research Organisation, Kintore Avenue, Adelaide 5000
Country 13980 0
Australia
Phone 13980 0
61 8 8303 8880
Fax 13980 0
Email 13980 0
[email protected]
Contact person for scientific queries
Name 4908 0
Professor Michael Fenech
Address 4908 0
Gate 13, Commonwealth Scientific and Industrial Research Organisation, Kintore Avenue, Adelaide 5000
Country 4908 0
Australia
Phone 4908 0
61 8 8303 8880
Fax 4908 0
Email 4908 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.