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Trial registered on ANZCTR


Registration number
ACTRN12614001024639
Ethics application status
Approved
Date submitted
16/09/2014
Date registered
24/09/2014
Date last updated
30/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The epigenetic effect of curcumin as measured in the blood and seen within lifestyle, for the prevention of Alzheimer's disease.
Scientific title
A randomised controlled study, investigating the epigenetic changes in expression of inflammatory genes through associated blood biomarkers, using curcumin, in older healthy and mild cognitive impairment participants
Secondary ID [1] 285283 0
Nil known
Universal Trial Number (UTN)
U1111-1160-5103
Trial acronym
Linked study record
ACTRN12613000681752

Health condition
Health condition(s) or problem(s) studied:
Alzheimers disease 292785 0
Condition category
Condition code
Neurological 293084 293084 0 0
Alzheimer's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Healthy older people (n=12) will consume oral curcumin in capsule formulation, 1.5mg daily (x 3 divided doses) for a period of 3 or 6 months (optional extension by participant).

Arm 2: Mild Cognitive Impairment (n=12) will consume oral curcumin, in capsule formulation 1.5mg daily (x 3 divided doses) for a period of 3 or 6 months (optional extension by participant).

Adherence will be assessed by a capsule count at the 3 month TP and again at 6 months (if the optional extension has been elected). Monthly phone calls will be made to the participant to monitor self-reported compliance.


Intervention code [1] 290178 0
Prevention
Intervention code [2] 290179 0
Treatment: Other
Comparator / control treatment
Two control groups will be used as comparators, and will receive 'no treatment';
Arm 3: Healthy older people (n=12)
Arm 4: MCI (n=12)
All groups will have similar age, education, APOE and gender characteristics
Control group
Active

Outcomes
Primary outcome [1] 292945 0
The epigenetic effect of curcumin on inflammatory gene methylation as measured through blood based cytokines, interleukins and other macrophage inflammatory proteins within healthy and MCI groups.
Timepoint [1] 292945 0
Baseline (0) & 3 month, and an optional 6 month.
(Optional extension of participation to 6 months).
Primary outcome [2] 292946 0
To investigate the APOE genotype specific effects of BCM-95 on the expression of inflammatory genes through associated blood biomarkers
Timepoint [2] 292946 0
Baseline (0) & 3 month, and an optional 6 month.
(Optional extension of participation to 6 months).
Secondary outcome [1] 309996 0
Determine whether sleep quality is altered by curcumin consumption, using PQSI (sleep) questionnaire, which will be assessed at baseline and at the end of the trial.
Timepoint [1] 309996 0
Baseline (0) & 3or 6 months,
Participants will be given the option of extending participation to 6 months.
Secondary outcome [2] 310607 0
Determine whether nutritional intake patterns are altered by curcumin consumption, using FFQ questionnaire (nutrition) which will be assessed at baseline and at the end of the trial.
Timepoint [2] 310607 0
Baseline (0) & 3 or 6 months,
Participants will be given the option of extending participation to 6 months.
Secondary outcome [3] 310608 0
Determine whether activity levels are altered by curcumin consumption, using CHAMPS questionnaire (activity level) which will be assessed at baseline and at the end of the trial.
Timepoint [3] 310608 0
Baseline (0) & 3 or 6 months,
Participants will be given the option of extending participation to 6 months.
Secondary outcome [4] 310610 0
Determine whether cognitive function is altered by curcumin consumption, which are assessed at baseline and at the end of the trial, using MMSE, Digit Span, SCIQ.
Timepoint [4] 310610 0
Baseline (0) & 3 or 6 months,
Participants will be given the option of extending participation to 6 months.

Eligibility
Key inclusion criteria
Arm 1: Healthy Volunteers
1. Age 65-90 years, with general good health.
2. No significant history of cerebral vascular disease, such as
a stroke, within the last 5 years.
3. Living in independent living units, or similar accommodation
4. English speaker, with adequate vision and hearing to enable testing
5. Normal general cognitive function, as determined by a Montreal Cognitive Assessment (MoCA) score, greater than or equal to 26.
6. No change in ADLs as determined by a clinical interview, and confirmed by an informant using the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)

Arm 2: Mild Cognitive Impairment Volunteers
1-4, as listed above
5. Impairment in one or more cognitive domains including memory, executive function, attention, language, and visuospatial skills
6. A MoCa score of between 25-18 (age and education stratified) as agreed based on a clinical panel review.
7. Preservation of independence in functional abilities.


Minimum age
65 Years
Maximum age
90 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Diagnosis of dementia based on the revised NIA/AA criteria
2. MoCA score of less than or equal to 17
3. Prior history of stroke within the last 5 years
4. Significant psychiatric disorder, including schizophrenia or
bipolar disorder
5. History of alcohol or drug abuse / dependence within 2
years of screening
6. Uncontrolled, clinical or subclinical depression as evidenced
by a score of greater or equal to 4 on the Geriatric
Depression scale.
7. Uncontrolled hypertension (systolic BP >170; diastolic BP >
100)
8. Gastro-intestinal symptoms or conditions that are
considered contra-indicated in the use of curcumin e.g.
obstruction of the biliary tract

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)
Healthy participants (n=12) will be drawn from in the Primary MK002 (n=100), who are not involved in the intervention of the primary study.
These participants will be offered involvement in the sub-study.

MCI participants will be recruited through the process of screening within our primary study. Those assessed as MCI would not be eligible for the primary study, so can be offered the sub study. Other MCI participants will be contacted from our research database).

Allocation will be done by contacting via computer/phone an "off site" administrator, within another state, at a central research office.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A remote site, computer generated randomisation process will be used to allocate intervention or non-intervention to those recruited in the study, within each MCI and HC groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


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 variable used to assess differences between the two open label intervention groups and two non-intervention groups are epigenetic changes in inflammatory gene expression, as measured within the blood.

Using the G*Power software (version 3.1.5) for Power analysis (1 - Beta) indicated a sample size N equals 12 per group is required to detect any significant differences between groups at greater than/ equal to 80% power and alpha equal to 0.05. The analysis may include 4 covariates (age, gender, APOE e4 allele status, education) and a commonly used F test (e.g. ANCOVA).



Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 8661 0
2229 - Taren Point
Recruitment postcode(s) [2] 8691 0
2154 - Castle Hill

Funding & Sponsors
Funding source category [1] 289902 0
Charities/Societies/Foundations
Name [1] 289902 0
McCusker Alzheimer's Research Foundation
Address [1] 289902 0
Suite 22 / Hollywood Private Hospital
85 Monash Avenue,
Nedlands, 6009,WA
Country [1] 289902 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
McCusker Alzheimers Research Foundation
Address
Suite 22, Hollywood Medical Centre
85 Monash Ave, Nedlands 6009 WA


Country
Australia
Secondary sponsor category [1] 288591 0
Other
Name [1] 288591 0
Anglican Retirement Villages
Address [1] 288591 0
2 Alexander Avenue, Taren Point, 2229, NSW
Country [1] 288591 0
Australia
Other collaborator category [1] 278146 0
University
Name [1] 278146 0
Latrobe University
Address [1] 278146 0
Crn Plenty Road and Kingsbury Drive,
Melbourne, Victoria, 3086
Country [1] 278146 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291661 0
Bellbury Ethics
Ethics committee address [1] 291661 0
129 Glen Osmond Road
Eastwood
South Australia, 5065
Ethics committee country [1] 291661 0
Australia
Date submitted for ethics approval [1] 291661 0
Approval date [1] 291661 0
05/09/2014
Ethics approval number [1] 291661 0
2012-09-1086-A-3

Summary
Brief summary
This study examines the effect of curcumin taken orally, within a broader study investigating curcumin in the prevention of Alzheimer's disease. Participants will be allocated to either, no treatment or curcumin, for a period of 3-6 months. At the beginning and conclusion of the study, they will be required to undertake a brief cognitive assessment, answer lifestyle questions and donate blood. A once only mouth swab will also be taken.
The intention of the study is to measure the influence of curcumin on the expression of inflammatory genetic markers, to examine if it is useful in reducing inflammation, by measuring associated proteins in the blood.
The influence of curcumin on existing lifestyle patterns including sleep, activity levels and nutrition will also be examined through questionnaires at the end of the study.

Trial website
Trial related presentations / publications
Public notes
This study is a sub study of the McCusker KARVIAH: Investigating curcumin in preventing Alzheimers disease_MK002

ACTRN12613000681752

Contacts
Principal investigator
Name 50762 0
Prof Ralph Martins
Address 50762 0
McCusker Alzheimer's Research Foundation
Suite 22/ 85 Hollywood Medical Centre
85 Monash Avenue,
Nedlands,
6009
WA
Country 50762 0
Australia
Phone 50762 0
+61 08 9347 4200
Fax 50762 0
+61 08 9347 4299
Email 50762 0
r.martins@ecu.edu.au
Contact person for public queries
Name 50763 0
Ms Candice Man Yan
Address 50763 0
McCusker KARVIAH Research Centre
Anglican Retirement Village (ARV)
Fairfax House
Broughton Avenue,
Castle Hill, 2154
NSW
Country 50763 0
Australia
Phone 50763 0
+61 02 8820 2914
Fax 50763 0
Email 50763 0
candice.manyan@arv.org.au
Contact person for scientific queries
Name 50764 0
Ms Kathryn Goozee
Address 50764 0
McCusker KARVIAH Research Centre
Anglican Retirement Village (ARV)
Fairfax House
Broughton Avenue,
Castle Hill, 2154
NSW
Country 50764 0
Australia
Phone 50764 0
+61 2 449 901899
Fax 50764 0
+61 2 9421 2222
Email 50764 0
kathryn.goozee@anglicare.org.au

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary