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Trial registered on ANZCTR
Registration number
ACTRN12611000437965
Ethics application status
Approved
Date submitted
22/04/2011
Date registered
28/04/2011
Date last updated
24/05/2011
Type of registration
Prospectively registered
Titles & IDs
Public title
Biocurcumax from curry spice turmeric in retaining cognitive function.
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Scientific title
Evaluation of Nutritional Extract Bio-curcumax (trademark (TM)) (BCM-95) to preserve cognitive functioning.
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Secondary ID [1]
259979
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Nil
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Universal Trial Number (UTN)
U1111-1120-9562
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Subjective memory complainers.
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Condition category
Condition code
Neurological
265750
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0
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Alzheimer's disease
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Alternative and Complementary Medicine
265831
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0
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Herbal remedies
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Public Health
265832
265832
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0
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Epidemiology
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Nutritional therapy using a standardised curcumin extract from turmeric in preserving memory.
Duration: A randomized double-blind-placebo-control study for a period of 12 months.
Mode of administration: Oral administration.
Dose: Ingestion of 500 mg BCM-95(R)CG (BiocurcumaxTM) / placebo capsules three times per day(total 1500mg/day).
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Intervention code [1]
264389
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Treatment: Other
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Intervention code [2]
264390
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Prevention
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Intervention code [3]
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Lifestyle
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Comparator / control treatment
A randomized double-blind-placebo-control study will be conducted for a period of 12 months. Eligible subjects will be randomised into two groups, an experimental group consuming the supplement BCM-95(R)CG (BiocurcumaxTM) and a control group consuming a placebo.
Group I – Ingestion of 3 x 500 mg BCM-95(R)CG (BiocurcumaxTM) capsules three times a day (1500 mg/day total), 500 in the morning, 500 at noon and 500 in the evening before meals with a glass of water.
Group II - Ingestion of 3 x 500 mg placebo capsules three times a day (1500 mg/day total), 500 in the morning, 500 at noon and 500 in the evening before meals with a glass of water.
The placebo and BCM-95(R)CG (BiocurcumaxTM) capsules will be identical in size and look (green coloured hard gelatin shell of '0' size).
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Retain cognitive function.
psychometric testing using standardized, validated diagnostic tools.
1. Mini-Mental State Examination (MMSE).
2. CAMDEX-R
3.(CAMCOG)-R
4. Rey Auditory Verbal Learning Test(RAVLT)
5. Depression Anxiety and Stress Scales (DASS)
6. Memory Functioning Questionnaire
7. Controlled Oral Word Association (COWAT)
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Assessment method [1]
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Timepoint [1]
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baseline (0 months and after 12 months)
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Secondary outcome [1]
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Decrease in AD blood biomarkers.
A sensitive double-antibody sandwich ELISA assay will be used for the detection and measurement of Amyloid beta 40, Amyloid beta 42 and Apolipoprotein E.
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Assessment method [1]
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Timepoint [1]
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0 months and 12 months
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Eligibility
Key inclusion criteria
Inclusion Criteria: The eligibility criteria will be as follows:
1) age 40-90 years, with good health and no significant cerebral vascular disease.
2) Memory complaint, preferably corroborated by an informant.
3) Objective memory impairment (based on cognitive test scores).
4) Normal general cognitive function.
5) Intact ADL i.e. no or minimal impairment in activities of daily living (ADLs), as determined by a clinical interview.
6) Not demented and
7) Clinical Dementia Rating [CDR] and a Mini-Mental State Examination (MMSE) score greater than or equal to 24.
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Minimum age
40
Years
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Maximum age
90
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Exclusion Criteria:
1) diagnosis of dementia (DSM-IV).
2) prior medical history of stroke.
3) a Mini-Mental State Examination (MMSE) score lower that 24.
4) present with depression based on the ICD-10 algorithm within the Cambridge Examination for Mental Disorders of the Elderly (CAMDEX)].
5) presence of acute functional psychiatric disorder (including drug and alcohol misuse).
6) bleeding risk factors and
7) non-fluency in English.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A randomized double-blind-placebo-control study will be conducted for a period of 12 months. Eligible subjects will be randomised into two groups, an experimental group consuming the supplement BCM-95 (R) CG (BiocurcumaxTM) and a control group consuming a placebo.
Allocation will involve by contacting the holder of allocation schedule who is at central administration.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using randomisation table from a statistic book.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
23/05/2011
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
300
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
264924
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Commercial sector/Industry
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Name [1]
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Arjuna Natural Extracts LTD, Kerala, India.
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Address [1]
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PB 126 Bank Road
Alwaye
Kerala, India
683 101
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Country [1]
264924
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Australia
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Funding source category [2]
264950
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University
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Name [2]
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Edith Cowan University
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Address [2]
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Centre of Excellence for Alzheimer's disease Research and Care
School of Exercise, Biomedical and Health Sciences
Edith Cowan University
270 Joondalup Drive, Joondalup,
WA, 6027
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Country [2]
264950
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Australia
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Primary sponsor type
Individual
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Name
Prof Ralph Martins
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Address
Centre of Excellence for Alzheimer's disease Research and Care
School of Exercise, Biomedical and Health Sciences
Edith Cowan University
270 Joondalup Drive, Joondalup,
WA, 6027
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Country
Australia
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Secondary sponsor category [1]
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Commercial sector/Industry
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Name [1]
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Arjuna Natural Extracts LTD, Kerala, India.
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Address [1]
264025
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PB 126 Bank Road
Alwaye
Kerala, India
683 101
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Country [1]
264025
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India
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
266882
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Hollywood Private Hospital Ethics Committee
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Ethics committee address [1]
266882
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Monash Avenue
Nedlands
WA 6009
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Ethics committee country [1]
266882
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Australia
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Date submitted for ethics approval [1]
266882
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Approval date [1]
266882
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Ethics approval number [1]
266882
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HPH 301
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Ethics committee name [2]
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Edith Cowan University
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Ethics committee address [2]
266909
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Centre of Excellence for Alzheimer's disease Research and Care
School of Exercise, Biomedical and Health Sciences
Edith Cowan University
270 Joondalup Drive, Joondalup,
WA, 6027
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Ethics committee country [2]
266909
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Australia
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Date submitted for ethics approval [2]
266909
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Approval date [2]
266909
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Ethics approval number [2]
266909
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Summary
Brief summary
Curcumin, the main bioactive ingredient of the common food spice turmeric has been reported to have many beneficial effects on decreasing Alzheimer’s Disease (AD) pathogenesis. However, its low absorption in the body has limited its clinical impact and not translated into clinical benefits. Methods to increase its oral bioavailability are a subject of intense current research. BCM-95(R)CG (BiocurcumaxTM), a novel bio-enhanced preparation of curcumin and has been reported to be more absorbed in the body compared to curcumin. This proposal will evaluate the potential efficacy of BCM-95(R)CG (BiocurcumaxTM) in preserving memory and cognitive functioning in older individuals with subjective memory complaints over a 12 month period.
Research hypotheses
1. BCM-95(R)CG (BiocurcumaxTM) will slow cognitive decline over 12 months compared to placebo.
2. BCM-95(R)CG (BiocurcumaxTM) will alter AD related biomarkers over 12 months compared to placebo.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Prof Ralph Martins
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Address
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Centre of Excellence for Alzheimer's disease Research and Care
School of Exercise, Biomedical and Health Sciences
Edith Cowan University
270 Joondalup Drive, Joondalup,
WA, 6027
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Country
15718
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Australia
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Phone
15718
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+61 8 6304 5456
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Fax
15718
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+61 8 6304 5851
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Email
15718
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[email protected]
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Contact person for scientific queries
Name
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Prof Ralph Martins
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Address
6646
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Centre of Excellence for Alzheimer's disease Research and Care
School of Exercise, Biomedical and Health Sciences
Edith Cowan University
270 Joondalup Drive, Joondalup,
WA, 6027
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Country
6646
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Australia
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Phone
6646
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+61 8 6304 5456
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Fax
6646
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+61 8 6304 5851
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Email
6646
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[email protected]
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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
Source
Title
Year of Publication
DOI
Embase
Use of curcumin, a natural polyphenol for targeting molecular pathways in treating age-related neurodegenerative diseases.
2018
https://dx.doi.org/10.3390/ijms19061637
Dimensions AI
Multiple antidepressant potential modes of action of curcumin: a review of its anti-inflammatory, monoaminergic, antioxidant, immune-modulating and neuroprotective effects
2012
https://doi.org/10.1177/0269881112458732
Dimensions AI
Examining the potential clinical value of curcumin in the prevention and diagnosis of Alzheimer’s disease
2015
https://doi.org/10.1017/s0007114515004687
N.B. These documents automatically identified may not have been verified by the study sponsor.
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