Retinal Metabolic Imaging of Alzheimer Patient

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Alzheimer Disease

Clinical Trial Details

NCT number	NCT03420807
Study type	Interventional
Source	Optina Diagnostics Inc.
Contact
Status	Completed
Phase	N/A
Start date	December 4, 2017
Completion date	March 12, 2020

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.