Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001113448
Ethics application status
Approved
Date submitted
8/08/2016
Date registered
17/08/2016
Date last updated
17/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
KARVIAH Sub-study: Examining the use of curcumin on cognition and mood in an older population
Scientific title
KARVIAH Sub-study: Examining the influence of acute on chronic administration of curcumin on cognition and mood in an older population
Secondary ID [1] 289661 0
MK002_AOC
Universal Trial Number (UTN)
U111-1185-2597
Trial acronym
KARVIAH - Kerr Anglican Retirement Village Initiative in Ageing Health.
Linked study record
This study is a sub-study of the linked ACTRN 12613000681752 registered trial

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's disease 299461 0
depression 299858 0
Condition category
Condition code
Neurological 299818 299818 0 0
Alzheimer's disease
Mental Health 299819 299819 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a sub-study of an existing trial examining the influence of long term administration of curcumin (500mg 3 times daily) in an older population (ACTRN 12613000681752).

Participants within the existing curcumin study will be eligible to participate in this sub-study investigating the acute influence of curcumin, on those already consuming a chronic dose.

In the early morning, prior to taking their prescribed investigational product (IP) curcumin, the participants will undertake cognitive testing using a computerised battery and complete a questionnaire to evaluate their working memory, attention and mood. They will then be provided a standardised breakfast and administered their usual investigational product, (oral Curcumin 500mg or placebo), as previously randomised in the main ACTRN 12613000681752 study.
Exactly 1 hour post the investigational product participants will repeat the cognitive battery to examine the influence of curcumin or placebo on working memory, attention and mood. A standardised morning tea will then be provided at a designated time.
Exactly 3 hours post the IP dose the participants will repeat the cognitive battery and questionnaire to examine the influence of curcumin or placebo on working memory, attention and mood as compared with baseline.
Intervention code [1] 295288 0
Prevention
Comparator / control treatment
A placebo (non active) formulation of the same appearance and colour is used for this study.
Control group
Placebo

Outcomes
Primary outcome [1] 298918 0
Attention tasks as measured using a computerised cognitive battery (CogState)
Timepoint [1] 298918 0
Baseline (0) prior to IP administration; 1 hour post dose; and 3 hours post dose.
Primary outcome [2] 299295 0
Working memory as measured using a computerised cognitive battery (CogState)
Timepoint [2] 299295 0
Baseline (0) prior to IP administration, 1 hour post dose and 3 hours post dose.
Secondary outcome [1] 325645 0
Mood as measured using the depression and anxiety sub scale (DASS)
Timepoint [1] 325645 0
Baseline (0) prior to IP administration; and 3 hours post dose
Secondary outcome [2] 326772 0
Anxiety as measured using the depression and anxiety sub scale (DASS)
Timepoint [2] 326772 0
Baseline (0) prior to IP administration and 3 hours post dose

Eligibility
Key inclusion criteria
Participant within the KARVIAH study - ACTRN 12613000681752
Cognitively healthy participants, as determined by the MoCA score.
Able to undertake a computerised battery
No evidence of depression
Male or female
(full inclusion as per main study)
Minimum age
65 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Diagnosis of dementia based on the revised criteria from NIA / AA
or evidence of cognitive decline suggesting MCI
Evidence of depression based on the DASS
(full exclusion as per main study)

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was undertaken within the main study (ANZCT 12613000681752) and double blind concealment is maintained.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
As per ANZCT 12613000681752
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sub-study on working memory and mood is a proof of concept study. A power analysis was not undertaken. It is anticipated that the number of participants that would volunteer would be between 30-40.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/08/2016
Actual
Date of last participant enrolment
Anticipated
21/12/2016
Actual
Date of last data collection
Anticipated
21/12/2016
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 294048 0
Commercial sector/Industry
Name [1] 294048 0
Anglicare Community Services
Country [1] 294048 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Macquarie University, NSW 2109, Australia
Country
Australia
Secondary sponsor category [1] 292872 0
Charities/Societies/Foundations
Name [1] 292872 0
McCusker Alzheimers Research Foundation
Address [1] 292872 0
Suite 22, 85 Monash Avenue, Nedlands WA 6009
Country [1] 292872 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295691 0
Bellberry Ltd
Ethics committee address [1] 295691 0
129 Glen Osmond Rd, Eastwood SA 5063
Ethics committee country [1] 295691 0
Australia
Date submitted for ethics approval [1] 295691 0
18/07/2016
Approval date [1] 295691 0
03/08/2016
Ethics approval number [1] 295691 0
2012-09-1086-A-7

Summary
Brief summary
This study aims to examinie the acute administration effects of curcumin, on a cohort already taking long-term curcumin. In an earlier study within another investigator team a report of a significant effect was observed one hour after administration of curcumin within sustained attention and working memory tasks of the intervention group as compared to placebo group. Given that the KARVIAH study design provides an opportunity to re-test this hypothesis, using a different formulation of curcumin, we would like to undertake the following as a sub-study with those participants who have completed their final assessment time-point within the curcumin study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67374 0
Prof Ralph N Martins
Address 67374 0
Macquarie University, NSW 2109, Australia
Country 67374 0
Australia
Phone 67374 0
+610404839305
Fax 67374 0
Email 67374 0
[email protected]
Contact person for public queries
Name 67375 0
Kathryn Goozee
Address 67375 0
Anglicare
12 Broughton Avenue, Castle Hill, 2154, NSW, Australia.
Country 67375 0
Australia
Phone 67375 0
+610449901899
Fax 67375 0
Email 67375 0
[email protected]
Contact person for scientific queries
Name 67376 0
Pratishtha Chatterjee
Address 67376 0
Macquarie University, NSW 2109, Australia
Country 67376 0
Australia
Phone 67376 0
+610451876983
Fax 67376 0
Email 67376 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.