None listed
Conditions
Brief summary
Alzheimer's Disease is characterised by the presence of beta-amyloid plaques in the brain. More recently, it has been proposed that these plaques may first appear in the retina, at the back of the eye before the plaques are detectable in the brain. Curcumin, found in the spice Tumeric, is a food additive that has molecular and optical properties that enhance the ability of the image amyloid plaques in the retina. Participants will be asked to have a eye imaging done before and after taking curcumin for 7 days. The presence/absence of plaques in the eye's retina will be correlated with the results obtained from participation in the AIBL study.
Interventions
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),
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.
Sponsors
McCusker Alzheimer's Disease Foundation
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
40 Years to 60 Years
Healthy volunteers
Yes
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.
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.
Outcome results
None listed