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 beta- amyloid plaques may first appear in the retina, at the back of the eye, before the plaques are detectable in the brain. This longitudinal study will investigate if the amyloid plaques identified in the retina increase in number and size over time. Curcumin, found in the spice turmeric, is a food additive that has molecular and optical properties that enable us to image amyloid plaques in the retina. Participants will be asked to have eye imaging done before and after taking curcumin for 7 days. The participant's image will be compared with other results from their participation in the NVI 1003 and AIBL studies. In addition, the results from participants with Mild Cognitive Impairment will be compared to the results from Healthy Control participants.
Interventions
Suitable participants will receive a 7 day course of Curcumin and an 8 day course of over the counter 500 IU of Vitamin E (taken as one capsule once per day). Clinic visits occur on day 0 and day 7. Curcumin dosing is on days 1-7 inclusive. Vitamin E dosing is on days 0-7 inclusive.
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, which is equivalent to
Suitable participants will receive a 7 day course of Curcumin and an 8 day course of over the counter 500 IU of Vitamin E (taken as one capsule once per day). Clinic visits occur on day 0 and day 7. Curcumin dosing is on days 1-7 inclusive. Vitamin E dosing is on days 0-7 inclusive. 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, which is equivalent to 4 grams of Curcumin. 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 ophthalmoscope. In addition, participants are 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 Research Foundation
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participant must have completed curcumin based fluorescence retinal imaging under the NVI003 study (ACTRN12613000367741) within the previous 21 months (please note that the NVI003 study is not the same as the AIBL study but the NVI003 study drew from AIBL data) 2. Participants must be able to provide written informed consent in English. 3. Male or Female age = 50
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 gallstone. 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. Participation in another clinical trial within 30 days prior to visit one (with the exception of the AIBL trial). ( Please note that the NVI003 study is not the same as the AIBL study but the NVI003 study drew from AIBL data).
Outcome results
None listed