Retinal Metabolic Imaging of Alzheimer Patient

NCT ID: NCT03420807

Last Updated: 2023-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-04
• Study Completion Date: 2020-03-12

Brief 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

Alzheimer Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

MHRC camera

Subjects will undergo a retina imaging session with the MHRC camera.

Group Type: EXPERIMENTAL

MHRC

Intervention Type: DEVICE

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

Interventions

MHRC

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Subjects with Alzheimer's disease

• Meet criteria for probable, possible Alzheimer's disease by McKhann criteria (McKhann et al. 2011)
• Mini-Mental State Examination score between 20 and 27 (inclusive)
• Vascular load scale ≤ 4 (Hachinski Ischaemia Score)
• Sufficient degree of cooperation to undergo all examinations
• Availability of a reliable responsible study partner to accompany the patient to the appointments

2. Subjects with Mild Cognitive Impairment

• Meet criteria for amnestic single or multi domain Mild Cognitive Impairment (without crossing the threshold for dementia)
• No signs of systemic, neurologic or psychiatric disorders that can cause cognitive deficits
• Scores on cognitive tests: 1 to 1.5 standard deviation below the mean of their age and education matched peers
• Diagnosis that follows Albert criteria (Albert et al. 2011)

3. Healthy control subjects

• No clinical signs of dementia
• Telephone Mini-Mental State Examination score ≥ 25 or
• MoCA ≥ 26
• Behavioural Neurology Assessment-R (BNA-R; Annex IX; within limits on all sub tests)

Exclusion Criteria

• Presence of one or more contraindications (PET and/or MRI)
• Presence of glaucoma or retinopathy (diabetic, macular degeneration)
• Pupil dilation inadequate or contraindicated
• Deficient visual fixation
• Refractive error outside the range -9 to +9
• Impossibility of obtaining satisfactory, quality images with MHRC

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

McGill University

OTHER

Sponsor Role: collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: collaborator

Optina Diagnostics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sandra Black, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Locations

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

071317

Identifier Type: -

Identifier Source: org_study_id