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Trial registered on ANZCTR


Registration number
ACTRN12620001325998
Ethics application status
Approved
Date submitted
15/09/2020
Date registered
8/12/2020
Date last updated
8/12/2020
Date data sharing statement initially provided
8/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
KARVIAH_XTND : Longitudinal follow-up study examining the health and wellbeing of participants for identifying new biomarkers and the impact of lifestyle. (Following a 12 month intervention of curcumin for the prevention of Alzheimer's disease.)
Scientific title
KARVIAH_XTND: Longitudinal follow-up of the KARVIAH cohort examining the influence of lifestyle and comorbidities on Alzheimer's disease (AD), Also to investigate if any effect of curcumin for the prevention of (AD) with examining cognition, blood and brain biomarkers.
Secondary ID [1] 297370 0
None
Universal Trial Number (UTN)
U1111-1217-1212
Trial acronym
KARVIAH_XTND
Linked study record
This study is collecting prospective data and is a longitudinal study, We are using identical data collection approaches used during the McCusker KARVIAH study(ACTRN12613000681752) for blood results, brain imaging, and lifestyle assessments. All the tools and questionnaires used are mentioned in the intervention/exposure section.

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's disease (AD) 311503 0
Condition category
Condition code
Neurological 310138 310138 0 0
Alzheimer's disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The previous KARVIAH_MK002 study recruited cognitively healthy participants aged 65-90 yrs of age to participate in a 12 month intervention of curcumin 1500mg daily (500mg capsules taken 3 times per day) or placebo (identical non-active ingredient capsules) for a period of 12 months.

The KARVIAH_XTND study is a non-intervention study will investigate the current physical and cognitive health of participants based on cognitive and memory function, physical assessment, blood, urine, lifestyle, and cerebral PET amyloid imaging.
Recruitment will include participants previously recruited for the KARVIAH study in addition to new participants.


The KARVIAH_XTND will undertake cognitive assessments, collect blood and urine samples, and undertake health and lifestyle review, vital signs, gait and grip strength, in addition to brain (PET amyloid-beta) imaging.
Measures used for memory and cognitive function will include:
MoCA, Geriatric Depression Scale (GDS), Rey Auditory Verbal Assessment Long term memory (RAVALT), Clinical Dementia Rating (CDR) (sum of boxes), Depression, Anxiety and Stress (DASS), Wechsler Test of Adult Reading (WTAR); Mini-mental state examination (MMSE); Category fluency; Controlled Oral Word Association; Boston Naming Test; Digit Span test; Digit Symbol test. - all conducted annually.

Questionnaires: Assessment of Memory Complaint Questionnaire (MAC-Q) - Annual
Neuroticism-Extroversion-Openness Five Factor Inventory Personality Inventory - Once only
Prospective and Retrospective Memory Questionnaire (PRMQ) - Annual
Subjective Cognitive Impairement Questionnaire - Annual
Pittsburgh Quality Sleep Index - Annual
Community Healthy Activities Model Program for seniors - Annual
Food Frequency Questionnaire - Annual
Physical health will be assessed using:
Mini Sarcopaenia Risk assessment - Annual
SF 36- Annual

Informant questionnaire (optional)

Alzheimer's Disease Cooperative Study - Activities of Daily living - annual
Dysexecutive Questionnaire - annual
Informant Questionnaires of Cognitive Decline in the Elderly - annual

All tests will be undertaken annually for a period of 3 years Post intervention (Kx0, 12, 24, 36 months), except for the PET amyloid brain image which is scheduled at Kx0 and the end of study. The PET image will measure the Standard Uptake Value Ratio of 18F-Florbetaben to assess cerebral amyloid-beta load.

Some information including medical health updates, and questionnaires can if preferred by the participant, conducted over the telephone to reduce the onsite length of visit, however, the cognitive testing, blood draw, vital signs and brain imaging, will require a face to face appointment.
Cognitive assessments are conducted by experienced raters, trained and supervised by a clinical neuropsychologist on the study.
Clinical assessment and governance is provided by the PI or nominated medical Sub-I.
The annual visit is expected to take up to 4 hours, with the all assessments undertaken (excluding brain imaging) at the KaRa Institute of Neurological Diseases, 35-41 Waterloo Road, Macquarie Park, 2113, NSW. Imaging procedures are conducted at the Macquarie Health Imaging Facility, Macquarie University, Macquarie Park.

Data collected in this study will be compared with previous data (blood, cognitive, lifestyle and PET amyloid imaging from the earlier McCusker KARVIAH study (completed 2016)
Intervention code [1] 313624 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319041 0
Evaluate the predictive value of pre-clinical biomarkers previously published during the KARVIAH study as measured by blood biomarker compared with the brain amyloid levels (measured using 18F-Florbetaben standard uptake value ratio (SUVR). SUVR range is considered high if equal to or greater than 1.35; SUVR is low if less than 1.35.
Blood biomarkers including serum and plasma ferritin, and phospholips were analysed as a continuous variable, and compared with the PET imaging results. The biomarkers are under research and no derfinite range is yet developed.
This outcome will be assessed in all participants.

Timepoint [1] 319041 0
All participants regardless of whether they were previously in the McCusker KARVIAH (MK002) study will be given an new ID being KX000_(time point) e.g. KX001_0
The comparative analysis will be done by accessing the master ID created within MK002 study.
KX_000 Baseline and annually thereafter for 3 years
Primary outcome [2] 325132 0
Evaluate the longitudinal change of health as measured using the self-reported tool known as the validated 36 item Short Form survey (SF-36) .
Timepoint [2] 325132 0
All participants regardless of previous participation will get a new baseline in KX000. (as mentioned above)
KX_000 Baseline and annually thereafter for 3 years
Primary outcome [3] 325133 0
Participants cognitive health will be assessed using the NIA_AA framework to determine current status and mild cognitive impairment (MCI) /Alzheimer's disease (AD) incidence, using the comprehensive cognitive battery to inform clinical decision.

All participants enrolled in this study will be assessed for the outcomes measures, including new participants not previously enrolled,
Timepoint [3] 325133 0
Baseline of KX, study and annually.
Secondary outcome [1] 386957 0
Evaluate the influence of sleep as measured using the validated validated Pittsburgh Quality Sleep Index, on cognitive function.
Timepoint [1] 386957 0
KX Baseline and annually thereafter for 3 years
Secondary outcome [2] 388026 0
Evaluate if the incidence of cognitive decline is influenced by increased frailty as measured by clinical frailty measures as mentioned in the intervention/exposure section.
Mini Sarcopaenia Risk assessment - Annual
Timepoint [2] 388026 0
KX Baseline and annually thereafter for 3 years
Secondary outcome [3] 389605 0
Evaluate the influence of physical activity as measured using the validated Community Healthy Activities Model Program for seniors (CHAMPS) questionnaire, on cognitive function.
Timepoint [3] 389605 0
KX Baseline and annually thereafter for 3 years
Secondary outcome [4] 389606 0
Evaluate the influence of dietary intake as measured using the validated Cancer Council Victorian Food Frequency Questionnaire (FFQ), on cognitive function.
Timepoint [4] 389606 0
KX Baseline and annually thereafter for 3 years

Eligibility
Key inclusion criteria
The Previous participant within the KARVIAH study (ACTRN 12613000681752) will be invited however, new participants will also be recruited matching the following criteria.
1. Minimum of 65 years of age
2. Generally healthy or medically stable and willing to undertake the visit schedule
3. Living in independent living units, or similar accommodation,
4.. English speaker,
5. Adequate vision and hearing
6. Able to complete cognitive testing
7. Willing to undertake a blood test
8. Willing to undertake an MRI/PET brain image (exclusion of this procedure is at the discretion of the PI)
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Presence of acute functional psychiatric disorder including; lifetime history of
schizophrenia or bipolar disorder,
2. Clinically significant abnormalities in the blood, which require clinical intervention
3. Prior medical history of a stroke within the last 2 years,
4. History of alcohol or drug abuse / dependence within 2 years of screening,
5. Hearing or visual impairments sufficient to hinder cognitive testing,
6. Any circumstance whereby the PI/Sub-Investigator feels that participation was not in
the best interest of the participant, or the participant was unable to meet the study
visit requirements.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
Results will be compared in the IBM SPSS Statistics software package using Generalised Linear Models. The pre-intervention (baseline) values will be used as a covariate in the analysis. Other covariates that will be considered include age, sex, education, APOE e4 status. Post-hoc comparison of means will be performed if the overall treatment comparison in the analysis of variance is significant. A two-way analysis of variance and multivariate analysis of variance will be used. Correlations between the various measures within each group will be assessed using Partial Pearson correlation coefficients.

Recruitment
Recruitment status
Not yet recruiting
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 hospital [1] 13203 0
KaRa Institute of Neurological Diseases - Macquarie Park
Recruitment postcode(s) [1] 25758 0
2113 - Macquarie Park

Funding & Sponsors
Funding source category [1] 301937 0
Charities/Societies/Foundations
Name [1] 301937 0
Anglicare Sydney
Address [1] 301937 0
Level 2/62 Norwest Blvd, Baulkham Hills NSW 2153
Country [1] 301937 0
Australia
Funding source category [2] 306743 0
University
Name [2] 306743 0
Macquarie University
Address [2] 306743 0
Balaclava Road, Macquarie Park, NSW 2109
Country [2] 306743 0
Australia
Primary sponsor type
Other
Name
KaRa Institute of Neurological Diseases Pty Ltd
Address
Suite 1.06, 35-41 Waterloo Road, Macquarie Park, 2113, NSW,
Country
Australia
Secondary sponsor category [1] 307292 0
None
Name [1] 307292 0
Address [1] 307292 0
Country [1] 307292 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302619 0
Bellbury Human Research Ethics Committee
Ethics committee address [1] 302619 0
123 Glen Osmond Road
Eastwood
South Australia 5063
Ethics committee country [1] 302619 0
Australia
Date submitted for ethics approval [1] 302619 0
19/03/2019
Approval date [1] 302619 0
15/09/2020
Ethics approval number [1] 302619 0
2019-03-190

Summary
Brief summary
The earlier KARVIAH Project recruited (n= 105) participants who took either curcumin or placebo orally for a period of 12 months. Participants were between the ages of 65-90 years living in retirement living accommodation or similar. Each participant undertook a health review, including general demographics, age, education, health and medication history and vital signs. During the study a comprehensive cognitive assessment was taken, blood drawn, lifestyle questionnaires completed (exercise, nutrition and sleep quality), as well as cerebral Magnetic Resonance Imaging (MRI); amyloid beta positron emission tomography (Aß- PET) and fluorodeoxyglucose (FDG-PET),

The KARVIAH_XTND study will investigate biomarkers and longitudinal quality of life measure post curcumin intervention, as well as non-modifiable and modifiable lifestyle and health risk factors which may influence cognitive function.
Trial website
https://www.karaminds.com.au/clinical-trials/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90842 0
A/Prof Kathryn Goozee
Address 90842 0
KaRa Institute of Neurological Diseases (KaRa MINDS)
Suite 1.06 35-41 Waterloo Road, Macquarie Park, NSW 2113
Country 90842 0
Australia
Phone 90842 0
+61 2 89607788
Fax 90842 0
+61 2 88708748
Email 90842 0
kathryn.goozee@karaminds.com.au
Contact person for public queries
Name 90843 0
Ms Preeti Dave
Address 90843 0
KaRa Institute of Neurological Diseases (KaRa MINDS)
Suite 1.06 35-41 Waterloo Road, Macquarie Park, NSW 2113
Country 90843 0
Australia
Phone 90843 0
+61289607788
Fax 90843 0
+61 (02) 98708748
Email 90843 0
preeti.dave@karaminds.com.au
Contact person for scientific queries
Name 90844 0
A/Prof Kathryn Goozee
Address 90844 0
KaRa Institute of Neurological Diseases (KaRa MINDS)
Suite 1.06 35-41 Waterloo Road, Macquarie Park, NSW 2113
Country 90844 0
Australia
Phone 90844 0
+61 2 89607788
Fax 90844 0
+61 2 88708748
Email 90844 0
kathryn.goozee@karaminds.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
de-identified individual participant data underlying published results only
When will data be available (start and end dates)?
Beginning 12 months and ending 5 years following main results publication
Available to whom?
case-by-case basis at the discretion of Primary Sponsor following methodologically sound proposal
Available for what types of analyses?
To achieve the aims in the approved proposal, and at the discretion of the Primary sponsor on a case by case basis.
How or where can data be obtained?
access subject to approvals by Principal Investigator, at kathryn.goozee@karaminds.com.au
What supporting documents are/will be available?
No other documents available
Summary results
No Results