Biocurcumax from curry spice turmeric in retaining cognitive function.

Evaluation of Nutritional Extract Bio-curcumax (trademark (TM)) (BCM-95) to preserve cognitive functioning.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000437965

Enrollment

300

Registered

2011-04-28

Start date

2011-05-23

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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).

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

40 Years to 90 Years

Healthy volunteers

Yes

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.

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.

Outcome results