None listed
Conditions
Brief summary
In Alzheimer’s disease, a peptide called amyloid-beta is elevated and aggregate forms amyloid-beta (senile) plaques/ deposits in the brain and potentially in the retina. Curcumin (an ingredient of turmeric) may increase the ability to detect the plaques in the retina. Participants will be recruited from the existing AIBL study. Images will be taken of the participants retina using a camera, Participants will then be asked to take 3 days of Vitamin E supplements and 3 days of Curcumin powder. At visit 2 (after the curcumin dosing), images will be again taken of the participant's retinas. A comparison will be made of the participants retinas pre and curcumin post dosing to determine if it is possible to detect the presence of plaques. These results will be compared to the participant's PET scan conducted during the course of the AIBL study.
Interventions
1. Tropicamide (0.5ml at 1%w/v), eye drops will be administered to each eye on Day 0 (visit one) and visit two of the study (day 3 of dosing). One drop in each eye is administered by the study staff/doctors). Tropicamide is a mydriatic agent that induces dilation of the pupil to facilitate taking images of the retina.
2. Vitamin E oral supplement equal to 500 IU daily in a tablet form to be taken for 3 days coinciding with the dosing of Longvida., It is administered in this study to improve t
1. Tropicamide (0.5ml at 1%w/v), eye drops will be administered to each eye on Day 0 (visit one) and visit two of the study (day 3 of dosing). One drop in each eye is administered by the study staff/doctors). Tropicamide is a mydriatic agent that induces dilation of the pupil to facilitate taking images of the retina. 2. Vitamin E oral supplement equal to 500 IU daily in a tablet form to be taken for 3 days coinciding with the dosing of Longvida., It is administered in this study to improve the bioavailability of curcumin from the Longvida supplement. The empty bottle of Vitamin E or any used tablets will be returned to the study site at the second study visit. 3. Curcumin will be supplied in the form of Longvida (Registered Trademark) a formulation designed to improve uptake of curcumin into the body. Each Longvida packet is 20 grams and contains 4 grams of curcumin. Participants are required to take one packet each day for 3 days. Longvida curcumin is granular in consistency and not water soluble. For palatability, participants will be provided with a choice of non-dairy low-lactose shake in which to mix their daily dose of Longvida curcumin. One option will be a special formulated shake for people with diabetes. Longvida (Registered Trademark) is considered an investigational or experimental product. Participants will be advised when to start the Longvida.. For some participants this will be the day after visit 1, for others, it will be at another time point as advised by the study staff to ensure 3 consecutive days of dosing prior to second imaging session. The empty or any unused packets of Lonvida will need to be returned to the study staff at the second visit. Imaging of the retinas will be done at the screening visit (Visit 1) and at the Day 3 visit (Visit 2) after Curcumin and Vitamin E dosing. The participant’s pupils will be dilated with eye drops prior to each imaging session. Photos will then be taken of the participants’ pupils by a trained operator using the retinal imaging camera RetisTM.
Sponsors
NeuroVision Imaging LLC
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Enrolled in the AIBL study with a A Ddiagnosis of MCI, or healthy controls within 36 months as per the AIBL criteria at the screening visit . 2. PET amyloid brain scan within 36 months of baseline visit 3. Participant must be able to provide written informed consent in English. 4. Male or Female age 60 years or older at the screening visit 5. In the opinion of the retinal photographer, clear ocular media and pupillary dilation to allow for ocular imaging
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) . 12. In the opinion of the investigator, the participant’s cognitive function is no longer consistent with the AIBL diagnosis.
Outcome results
None listed