Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000677505
Ethics application status
Approved
Date submitted
17/06/2015
Date registered
30/06/2015
Date last updated
24/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Imaging of Retinal Amyloid Plaques in Alzheimer’s disease - Middle aged Controls Study
Scientific title
A study to evaluate retinal amyloid plaques in a middle-aged control cohort, utilizing a retinal imaging system and curcumin labeling
Secondary ID [1] 286915 0
NVI003.B
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease 295336 0
Condition category
Condition code
Neurological 295603 295603 0 0
Alzheimer's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Suitable participants will receive a 7 day course of Curcumin and an 8 day course of over the counter Vitamin E 500IU (taken as one capsule once per day)

Curcumin will be supplied in the form of Longvida (Registered Trademark) sachets. Participants will take 20 grams of Longvida (Registered Trademark) each morning before breakfast for 7 days. This is equivalent to taking 4 grams of Curcumin per day. The sachets may be mixed with a low-lactose drink (supplied). Longvida, (Registered Trademark), is currently not registered for this indication in Australia and is therefore considered an investigational or experimental product.

At each clinic visit, participants will have a blood test and have photos taken of their eye retina's. To take the photos, pupil dilating eye drops will be instilled into the eyes. Photos will be taken with a scanning laser opthalmoscope.

In addition, participants will be asked to complete a medication diary during the course of the Curcumin/Vitamin E to record all the medication intake. All Curcumin and Vitamin E containers should be returned to the clinic even if they are empty.
Intervention code [1] 292101 0
Early detection / Screening
Comparator / control treatment
All suitable participants will receive Curcumin and Vitamin E.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295317 0
The primary endpoint is to investigate whether retinal amyloid plaques are evident in a younger control cohort, utilizing a retinal imaging system and curcumin labeling in participants.
Timepoint [1] 295317 0
Participants will be screened for the presence or absence of retinal amyloid plaques after 7 days of taking the investigational product. Baseline images will be collected at day 0, then more images taken after 7 days of curcumin dosing.
Secondary outcome [1] 315340 0
The second objective is to compare retinal Amyloid Beta protein plaque burden with brain Amyloid Beta protein plaque burden.
Timepoint [1] 315340 0
Comparison will be made between the retinal images (day 7) and the participant's most recent PET scan (PET scan will be conducted as part of the AIBL study). The AIBL study is not registered
Secondary outcome [2] 315341 0
The effect of other parameters on the retina-brain amyloid association, including ocular history, blood pharmacokinetics, demographics, and APOE genotype. Participant's details regarding demographics and ocular hsitory will be collected by interview with a study doctor at visit 1 (day 0). APOE gentoype information was collected in the AIBL study from a blood test. Pharmacokinetic information will be obtained from the blood tests conducted during this study with blood collection occurring at day 0 (visit 1) and day 7 (visit 2)
Timepoint [2] 315341 0
Details of other parameters will be collected at visit 1 (day 0, also known as baseline) and visit 2 (after 7 days of curcumin dosing) of this study. APOE gentoype information and brain plaque burden is collected during the course of the AIBL study.

Eligibility
Key inclusion criteria
1. Participant must be cognitive normal (as assessed in the AIBL study).
2. Participant must be able to provide written informed consent in English.
3. Male or Female age 40-60 years.
4. Participants must have had a brain amyloid imaging (PET scan) or plan to undertake a PET scan as part of the AIBL study within 6 months of completing the NVI003.B study.
Minimum age
40 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. The participant has advanced retinal disease, advanced cataracts or other advanced ocular conditions that in the opinion of the investigator are likely to affect obtaining clear images of the retina.
2. Participant has had prior ocular surgery within 2 months of planned retinal imaging, or is still taking post-operative ocular medications at first day of retinal imaging.
3. Participants with known current gallstones.
4. Participants who have undergone angioplasty in the last 3 months.
5 Participants who have had major surgery within 4 weeks of trial inclusion or planned surgical procedure during the trial period.
6. Significant haemorrhagic event (in past 12 months) or cardiovascular disease (ie, history of myocardial infarction within past 6 months of trial inclusion , congestive cardiac failure NYHA grade II ).
7. Participant with retinitis pigmentosa.
8. Participants with current bile duct obstruction (participants who have undergone a cholecystectomy will be considered eligible).
9. Participants with significant uncontrolled gastrointestinal disorders (including stomach ulcers and uncontrolled hyperacidity disorders) which in the opinion of the investigator will be aggravated by the intake of curcumin.
10. Participants with known allergy to Tropicamide eye drops, vitamin E or turmeric
11. Women who are of child bearing potential who do not agree to use reliable contraception from day 0 until at least 6 weeks after the last study drug administration. Pregnant or lactating females are not eligible. Women of childbearing potential must have a negative pregnancy test done prior to commencing study drug.
12. Participation in another clinical trial within 30 days prior to visit one (with the exception of the AIBL trial and behavioural interventions). Participants enrolled in clinical trials involving vitamins, herbal or dietary products may be eligible on a case-by-case following discussion with the medical monitor.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2015
Actual
27/10/2015
Date of last participant enrolment
Anticipated
Actual
8/12/2015
Date of last data collection
Anticipated
Actual
20/01/2016
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 3925 0
McCusker Alzheimer's Research Foundation - Nedlands
Recruitment postcode(s) [1] 9840 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 291474 0
Commercial sector/Industry
Name [1] 291474 0
Neuro Vision Inc
Country [1] 291474 0
United States of America
Primary sponsor type
Charities/Societies/Foundations
Name
McCusker Alzheimer's Disease Foundation
Address
115 Monash Ave
Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 290152 0
Commercial sector/Industry
Name [1] 290152 0
Neuro Vision Inc
Address [1] 290152 0
Suite 250
1395 Garden Highway
Sacramento CA 95833
Country [1] 290152 0
United States of America
Secondary sponsor category [2] 290153 0
Government body
Name [2] 290153 0
CSIRO
Address [2] 290153 0
Business Development Manager
Neurodegenerative Diseases, Preventative Health Flagship
343 Royal Parade
PARKVILLE VIC 3052
Country [2] 290153 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293022 0
Hollywood Private Hospital Research Ethics Committee
Ethics committee address [1] 293022 0
Ethics committee country [1] 293022 0
Australia
Date submitted for ethics approval [1] 293022 0
02/06/2015
Approval date [1] 293022 0
06/07/2015
Ethics approval number [1] 293022 0
HPH425

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

Contacts
Principal investigator
Name 58114 0
Prof Roger Clarnette
Address 58114 0
McCusker Alzheimer's Research Foundation
115 Monash Ave
Nedlands WA 6009
Country 58114 0
Australia
Phone 58114 0
+61 8 9389 6433
Fax 58114 0
Email 58114 0
Roger.Clarnette@health.wa.gov.au
Contact person for public queries
Name 58115 0
Kevin Taddei
Address 58115 0
McCusker Alzheimer's Research Foundation
2/142 Striling Highway
Nedlands WA 6009
Country 58115 0
Australia
Phone 58115 0
+61 8 6304 3966
Fax 58115 0
Email 58115 0
k.taddei@ecu.edu.au
Contact person for scientific queries
Name 58116 0
Shaun Frost
Address 58116 0
CSIRO DPAS WA Australian e-Health Research Centre
Private bag 5
WEMBLEY WA 6913
Country 58116 0
Australia
Phone 58116 0
+61 8 9333 6137
Fax 58116 0
Email 58116 0
shaun.frost@csiro.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

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