Trial Review

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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.
Scientific title
Evaluation of Nutritional Extract Bio-curcumax (trademark (TM)) (BCM-95) to preserve cognitive functioning.
Secondary ID [1] 259979 0
Nil
Universal Trial Number (UTN)
U1111-1120-9562
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Subjective memory complainers. 265604 0
Condition category
Condition code
Neurological 265750 265750 0 0
Alzheimer's disease
Alternative and Complementary Medicine 265831 265831 0 0
Herbal remedies
Public Health 265832 265832 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
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).
Intervention code [1] 264389 0
Treatment: Other
Intervention code [2] 264390 0
Prevention
Intervention code [3] 264391 0
Lifestyle
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).
Control group
Placebo

Outcomes
Primary outcome [1] 266533 0
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)
Timepoint [1] 266533 0
baseline (0 months and after 12 months)
Secondary outcome [1] 273992 0
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.
Timepoint [1] 273992 0
0 months and 12 months

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.
Minimum age
40 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using randomisation table from a statistic book.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/05/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264924 0
Commercial sector/Industry
Name [1] 264924 0
Arjuna Natural Extracts LTD, Kerala, India.
Country [1] 264924 0
Australia
Funding source category [2] 264950 0
University
Name [2] 264950 0
Edith Cowan University
Country [2] 264950 0
Australia
Primary sponsor type
Individual
Name
Prof Ralph Martins
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
Country
Australia
Secondary sponsor category [1] 264025 0
Commercial sector/Industry
Name [1] 264025 0
Arjuna Natural Extracts LTD, Kerala, India.
Address [1] 264025 0
PB 126 Bank Road
Alwaye
Kerala, India
683 101
Country [1] 264025 0
India

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266882 0
Hollywood Private Hospital Ethics Committee
Ethics committee address [1] 266882 0
Monash Avenue
Nedlands
WA 6009
Ethics committee country [1] 266882 0
Australia
Date submitted for ethics approval [1] 266882 0
Approval date [1] 266882 0
Ethics approval number [1] 266882 0
HPH 301
Ethics committee name [2] 266909 0
Edith Cowan University
Ethics committee address [2] 266909 0
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
Ethics committee country [2] 266909 0
Australia
Date submitted for ethics approval [2] 266909 0
Approval date [2] 266909 0
Ethics approval number [2] 266909 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32471 0
Address 32471 0
Country 32471 0
Phone 32471 0
Fax 32471 0
Email 32471 0
Contact person for public queries
Name 15718 0
Prof Ralph Martins
Address 15718 0
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
Country 15718 0
Australia
Phone 15718 0
+61 8 6304 5456
Fax 15718 0
+61 8 6304 5851
Email 15718 0
r.martins@ecu.edu.au
Contact person for scientific queries
Name 6646 0
Prof Ralph Martins
Address 6646 0
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
Country 6646 0
Australia
Phone 6646 0
+61 8 6304 5456
Fax 6646 0
+61 8 6304 5851
Email 6646 0
r.martins@ecu.edu.au

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
SourceTitleYear of PublicationDOI
EmbaseUse of curcumin, a natural polyphenol for targeting molecular pathways in treating age-related neurodegenerative diseases.2018https://dx.doi.org/10.3390/ijms19061637
Dimensions AIMultiple antidepressant potential modes of action of curcumin: a review of its anti-inflammatory, monoaminergic, antioxidant, immune-modulating and neuroprotective effects2012https://doi.org/10.1177/0269881112458732
Dimensions AIExamining the potential clinical value of curcumin in the prevention and diagnosis of Alzheimer’s disease2015https://doi.org/10.1017/s0007114515004687
N.B. These documents automatically identified may not have been verified by the study sponsor.