Imaging of Retinal Amyloid Plaques in Alzheimer’s disease - Middle aged Controls Study

Phase 2

Completed

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

• Registration Number: ACTRN12615000677505
• Lead Sponsor: McCusker Alzheimer's Disease Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-30
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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.
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. 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified