This study will evaluate if an eye examination can identify changes in the structure of the retina which may help in the early detection of Alzheimer’s disease.

Phase 2

Completed

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

• Registration Number: ACTRN12613000367741
• 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: 2013-04-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

A Diagnosis of Alzheimer’s Disease (AD), Mild Cognitive Impairment (MCI), and healthy controls (HC) as per the 'The Australian Imaging Biomarkers and Lifestyle (AIBL) Flagship Study of Ageing' criteria ( International Psychogeriatrics / Volume 21 / Issue 04 / August 2009, pp 672-687), stratified as follows:
AD – 10 patients (all Pittsburgh compound B positive (PiB+)) with mild to moderate AD - excluding severe AD)
MCI – 10 patients (5 PiB+, 5 PiB-)
HC – 20 patients (10 PiB+, 10 PiB-)

Participant must be able to provide informed consent.

Participant must be able to assign an individual who will help with recording protocol compliance.

Male or Female 'greater than or equal to' 50 years old

Clear ocular media and pupillary dilation to allow for ocular imaging.

Exclusion Criteria

Patients cannot have major cognitive impairment not associated with AD including a past history or magnetic resonance imaging (MRI) evidence of brain damage including significant trauma, stroke, hydrocephalus, lacunar infarcts, seizures, mental retardation or serious neurological disorder

History of alcoholism or drug addiction within the past year

A score of greater than 4 on the Modified Hachinski Ischemia Scale, indicative of cerebrovascular disease

Systemic illness that could influence the patient’s safety and compliance with the protocol e.g., severe hepatic, renal, cardiovascular or metabolic diseases that would significantly increase patient’s risk to participate in protocol

Advanced retinal disease, cataracts or other ocular conditions that may affect clear images of the retina.

Patients with current or previous bile duct obstruction, gallstones, and gastrointestinal disorders (including stomach ulcers and hyperacidity disorders)

Patients who are pregnant or breast feeding

Hostility or refusal to cooperate

Participation in another clinical trial within 30 days prior to the baseline visit (with the exception of the AIBL trial)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The objective of this study is to evaluate the ability to detect beta-amyloid plaques utilizing a retinal imaging system and curcumin labeling in patients with Alzheimer’s disease (AD), Mild Cognitive Impairment (MCI) as compared to age matched, healthy controls, to measure number of plaques, plaque area, and distribution in the retina. [imaging will be performed at Baseline and on Day 7.<br><br><br> ]