Clinical Trials Directory

Trials / Completed

CompletedNCT03420807

Retinal Metabolic Imaging of Alzheimer Patient

Evaluation of Beta-amyloid Plaques of the Retina Using Metabolic Hyperspectral Retinal Camera (MHRC) in Alzheimer's Patients - Toronto Study Arm

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
49 (actual)
Sponsor
Optina Diagnostics Inc. · Industry
Sex
All
Age
50 Years – 90 Years
Healthy volunteers
Accepted

Summary

This research project concerns the evaluation of the Metabolic Hyperspectral Retinal Camera (MHRC), a novel medical instrument from Optina Diagnostics, for the detection of beta-amyloid plaques, a hallmark of Alzheimer's disease (AD), in the retina. The experimental device, produces multiple images of the retina when subjected to light in very specific colors (90-100 specific colors typically) and may be used to identify specific biomarkers based on their unique spectral signature. The retina is an extension of the brain and is the only optically accessible nervous tissue. The MHRC could represent a simple and non-invasive tool to facilitate the diagnosis of AD.

Detailed description

Alzheimer's disease (AD), a neurodegenerative disorder characterized by cognitive impairment and a suspected dementia syndrome, is the most common type of dementia (\>50% of all cases), affecting millions worldwide, with no cure available at this time. Definite AD diagnosis currently relies on the post-mortem observation of the hallmarks β-amyloid peptides (Aβ) extracellular aggregates, Aβ plaques, and protein tau intracellular twisted strands (neurofibrillary tangles, NFTs). Earlier diagnosis could dramatically transform the design and execution of clinical trials to test new treatments. The eye offers a natural window to the brain as the retina, the light sensitive layer lining the interior of the eye is an extension of the brain. The presence of Aβ plaques in the retina of AD mice models and humans was recently reported opening the possibility of detecting this AD hallmark though a simple non-invasive eye scan. The proposed research aims to explore this avenue with the development of a spectrally-resolved optical retinal imaging platform to detect Aβ plaques in the retina of AD subjects and validate the method against brain Aβ plaques seen on amyloid PET imaging. The novel imaging platform is expected to help aid the early detection of AD and assist in monitoring efficacy of possible future therapeutic agents that target relevant molecular pathways.

Conditions

Interventions

TypeNameDescription
DEVICEMHRCEvaluate the feasibility of detection of beta-amyloid plaques by using their spectral signature in autofluorescence or reflectance.

Timeline

Start date
2017-12-04
Primary completion
2020-03-12
Completion
2020-03-12
First posted
2018-02-05
Last updated
2023-03-28

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT03420807. Inclusion in this directory is not an endorsement.