A cross-sectional study to evaluate the ability to detect retinal amyloid-beta plaques utilizing the EidonTM (RetiaTM) retinal imaging system with and without curcumin labeling in participants with Mild Cognitive Impairment (MCI), and healthy controls
- Conditions
- Mild cognitive impairmentNeurological - DementiasNeurological - Alzheimer's disease
- Registration Number
- ACTRN12616001679471
- Lead Sponsor
- euroVision Imaging LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 286
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
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.
5Participants 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The objective of this study is to explore the correlation between amyloid-beta (AB) plaques identified by fluorescence in the retina with PET SUVR and/or CSF AB42 testing in participants at risk for Alzheimer’s dementia previously enrolled in the AIBL Study.<br><br>The primary outcome measure will be the retinal images obtained at day 0 (visit 1) and day 3 of dosing (visit 2) (RetiaTM images)[Visit 1 and Visit 2 (day 3 of dosing)]
- Secondary Outcome Measures
Name Time Method Safety outcomes will be evaluated by measuring:<br>a) the incidence of adverse events <br>b) the incidence of serious adverse events<br><br>Assessment will be based on participant reports, either at the study visits or other contact with the site (eg phone call).<br><br>Common side effects (1% to 10% chance of occurring) from taking curcumin include<br>Diarrhoea<br>Nausea <br>Bloated feeling<br>Reflux <br>Anorexia<br><br>Participants may experience slight stinging and reddening of the eyes when the Tropicamide eyedrops are instilled. These are temporary side effects usually lasting less than 5 minutes.<br>Other very common side effects (greater than 10% chance of occurring) from eye drops may include<br>Intolerance to bright light.<br>Blurred vision <br><br>[Adverse events will be tracked until the final follow up safety phone call (30-35 days after visit 2).]