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Trial registered on ANZCTR


Registration number
ACTRN12613000681752
Ethics application status
Approved
Date submitted
7/06/2013
Date registered
20/06/2013
Date last updated
30/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
McCusker KARVIAH: Curcumin in Alzheimer's disease prevention
Scientific title
McCusker KARVIAH: Investigating the role of curcumin in preventing Alzheimer's Disease_MK002
Secondary ID [1] 282636 0
Nil
Universal Trial Number (UTN)
U1111-1144-1011
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention of Alzheimer's disease 289331 0
Condition category
Condition code
Neurological 289745 289745 0 0
Alzheimer's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be aged 65-90 and the introduction of the Curcumin (Biocurcumax TM) will be titrated as follows:
500mg daily for 2/ wks, progressing to
500mg twice daily (1,000mg/daily) for 2 weeks, then
500mg three times daily, (1,500mg) onwards

The Curcumin is formulated into a capsule and is taken with a glass of water after meals.

The intervention will be for a period of 12 months in total.
Intervention code [1] 287302 0
Prevention
Comparator / control treatment
The placebo capsule, contains roasted rice powder and is identical in colour, shape and size to the active capsule. The dosage frequency is consistent with the active treatment regime.
Control group
Placebo

Outcomes
Primary outcome [1] 289761 0
Biocurcumax will positively alter AD-related blood biomarker profiles compared with placebo
Timepoint [1] 289761 0
Baseline, 6 &12 months
Primary outcome [2] 289762 0
Biocurcumax TM will be associated with reduced amyloid ligand uptake as determined by Pib PET imaging as compared with placebo
Timepoint [2] 289762 0
Baseline, 12 months
Primary outcome [3] 289763 0
Biocurcumax will slow cognitive decline, as demonstrated by a battery of neuropsychological tests compared to placebo.

Tools used to assess cognitive function will include RAVLT; Wechsler Logical Memory-II; Category fluency; COWAT; BNT; Digit Span; Stroop; Rey; and the computer generated CogState (brief version).
Timepoint [3] 289763 0
Baseline, 12 months
Secondary outcome [1] 303189 0
Biocurcumax will increase brain glucose utilisation, as measured by FDG-PET, and correlate with improvement in cognitive functioning.
Timepoint [1] 303189 0
Baseline, 12 months
Secondary outcome [2] 303191 0
Biocurcumax will bind to aggregated ABeta in the retina and be detectable with fluorescence imaging
Timepoint [2] 303191 0
Baseline, 12 months
Secondary outcome [3] 303192 0
Biocurcumax levels of retinal fluorescence imaging will positively correlate with amyloid ligand uptake as determined by PET brain imaging
Timepoint [3] 303192 0
Baseline, 12 months
Secondary outcome [4] 303193 0
Biocurcumax will slow cognitive decline over 12 months compared to placebo.

Tools used to assess cognitive function will include RAVLT; Wechsler Logical Memory-II; Category fluency; COWAT; BNT; Digit Span; Stroop; Rey; and the computer generated CogState (brief version).
Timepoint [4] 303193 0
Baseline, 12 months
Secondary outcome [5] 303194 0
Lifestyle factors including lower levels of physical activity, as assessed by Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire; poorer diet as assessed by Food Frequency Questionnaire (FFQ-Cancer Council, Vic Version) and lower sleep quality as assessed the Pittsburgh Quality Sleep Index (PQSI), individually, negatively impact on the cognitive performance
Timepoint [5] 303194 0
Baseline, 12 months
Secondary outcome [6] 303195 0
Biocurcumax will slow cortical atrophy and loss of hippocampal volume as measured by MRI
Timepoint [6] 303195 0
Baseline, 12 months.

Eligibility
Key inclusion criteria
Age 65-90 years, with good health and no significant cerebral vascular disease

Living in independent living units, or similar accommodation

English speaker

Adequate vision and hearing to enable testing

Memory complaint as determined by MAC-Q, and preferably corroborated by an informant

No objective memory impairment, based on cognitive test scores

Normal general cognitive function as determined by a Montreal Cognitive Assessment (MoCA) score, greater than or equal to 26 during screening

No significant functional impairments

Intact ADL i.e. no or minimal impairment in activities of daily living (ADLs), as determined by a clinical interview
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

Montreal Cognitive Assessment (MoCA) score less than or equal to 17

Significant functional impairments/behavioural problems as indicated by the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) and the 36-Item Short Form Health Survey (SF-36)

Presence of acute functional psychiatric disorder including; lifetime history of schizophrenia or bipolar disorder

Prior medical history of stroke

History of alcohol or drug abuse / dependence within 2 years of screening

Depression, as indicated on the DASS

Use of Warfarin, within 4 weeks of screening

Current or previous bile duct obstruction, gallstones, and gastrointestinal disorder

Contraindication to MRI, including, but not limited to those with a pacemaker, presence of metallic fragments near the eyes or spinal cord, or cochlear implant

History of closed angle glaucoma, or related conditions, contraindicated for retinal scanning

Uncontrolled hypertension (systolic BP > 170 or diastolic BP > 100)

Any significant systemic illness or unstable medical condition that could lead to difficulty complying with the protocol including: history of myocardial infarction in the past year or unstable or severe cardiovascular disease including angina or congestive heart disease, chronic renal failure, chronic hepatic disease, severe pulmonary disease

Clinically significant and unstable gastrointestinal disorder such as ulcer disease or a history of active or occult gastrointestinal bleeding within two years.

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)
Stage 1 will involve recruiting 200 participants who will undertake a comprehensive health assessment, including cognition, blood and buccal cell swab and lifestyle questionnaires.
100 participants, assessed as most at risk of AD will then proceed to the intervention (curcumin / placebo). At this point Allocation will be done under concealment, by the NSW study site contacting the allocation schedule holder, who is located in WA 'central laboratory'. This will be done by email/phone correspondence.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation is done using a dynamic random allocation process, using a computer generated table for recording, the two groups will be stratified for gender, age, education and ApOE4 status.
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
Safety/efficacy
Statistical methods / analysis
In the current study, the main outcome variables used to assess differences between the intervention and placebo groups are cerebral amyloid load, cognitive and clinical measures. Using the G*Power software (version 3.1.5) for Power analysis (1 - Beta) indicated a sample size N equals 100 is required to detect any significant differences between two groups at greater than/ equal to 80% power and alpha equal to 0.05. The analysis may include 4 covariates (age, sex, APOE e4 allele status, and education) and a commonly used F test (e.g. ANCOVA).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/06/2013
Actual
24/06/2013
Date of last participant enrolment
Anticipated
Actual
27/09/2015
Date of last data collection
Anticipated
4/11/2016
Actual
27/10/2016
Sample size
Target
200
Accrual to date
Final
134
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 6953 0
2229 - Taren Point
Recruitment postcode(s) [2] 7557 0
2232 - Kirrawee
Recruitment postcode(s) [3] 7558 0
2154 - Castle Hill

Funding & Sponsors
Funding source category [1] 287417 0
Charities/Societies/Foundations
Name [1] 287417 0
McCusker Alzheimer's Research Foundation
Country [1] 287417 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
McCusker Alzheimer's Research Foundation
Address
Suite 22, 85 Monash Avenue, Nedlands, WA. 6009,
Country
Australia
Secondary sponsor category [1] 286164 0
Charities/Societies/Foundations
Name [1] 286164 0
Foundation for Aged Care, ARV
Address [1] 286164 0
284 Castle Hill Road, Castle Hill, 2154, NSW
Country [1] 286164 0
Australia
Secondary sponsor category [2] 286166 0
Charities/Societies/Foundations
Name [2] 286166 0
Edith Cowan University
Address [2] 286166 0
270 Joondalup Dr Joondalup WA 6027
Country [2] 286166 0
Australia
Other collaborator category [1] 277445 0
Commercial sector/Industry
Name [1] 277445 0
Anglican Retirement Villages, ARV, Sydney
Address [1] 277445 0
P.O. Box 284, Castle Hill 1765, NSW
Country [1] 277445 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289393 0
Bellbury Human Research Ethics Committee
Ethics committee address [1] 289393 0
Ethics committee country [1] 289393 0
Australia
Date submitted for ethics approval [1] 289393 0
Approval date [1] 289393 0
02/04/2013
Ethics approval number [1] 289393 0
2012-09-1086-A1
Ethics committee name [2] 289394 0
University of Western Australia
Ethics committee address [2] 289394 0
Ethics committee country [2] 289394 0
Australia
Date submitted for ethics approval [2] 289394 0
Approval date [2] 289394 0
04/06/2013
Ethics approval number [2] 289394 0
RA/4/1/6225

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40494 0
Prof Ralph N. Martins
Address 40494 0
McCusker Alzheimer's Research Foundation
Suite 22, 85 Monash Avenue,
Nedlands, 6009
W.A.
Country 40494 0
Australia
Phone 40494 0
+61893474201
Fax 40494 0
Email 40494 0
r.martins@ecu.edu.au
Contact person for public queries
Name 40495 0
Kathryn G. Goozee
Address 40495 0
Anglican Retirement Villages,
C/- McCusker KARVIAH Research Centre
2 Alexander Avenue,
Taren Point, 2229, NSW
Country 40495 0
Australia
Phone 40495 0
+61297107352
Fax 40495 0
Email 40495 0
kathryn.goozee@anglicare.org.au
Contact person for scientific queries
Name 40496 0
Kevin Taddei
Address 40496 0
Sir James McCusker Alzheimers Disease Research Laboratory, Edith Cowan University; and McCusker Alzheimer's Research Foundation

Suite 22, 85 Monash Avenue, Nedlands 6009, WA
Country 40496 0
Australia
Phone 40496 0
+61893474201
Fax 40496 0
Email 40496 0
k.taddei@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
Dimensions AIExamining the potential clinical value of curcumin in the prevention and diagnosis of Alzheimer’s disease2015https://doi.org/10.1017/s0007114515004687
EmbaseEfficacy of curcumin for age-associated cognitive decline: a narrative review of preclinical and clinical studies.2018https://dx.doi.org/10.1007/s11357-018-0017-z
N.B. These documents automatically identified may not have been verified by the study sponsor.