Imaging of Retinal Amyloid Plaques in Alzheimer’s disease – Longitudinal Study.

Phase 2

Completed

• Conditions: Alzheimer's Disease; Neurological - Alzheimer's disease

• Registration Number: ACTRN12615000465550
• Lead Sponsor: McCusker Alzheimer's Research Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-13
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified