Retinal Metabolic Imaging of Alzheimer Patient

NCT03420807 | Completed

• 1 other identifier: 071317
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• Retinal beta-amyloid detection

  Presence of absence of beta-amyloid plaques in the retina

  Within 21 days following clinical characterization completion

Study Arms (1)

MHRC camera

EXPERIMENTAL

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

Device: MHRC

Interventions

MHRC DEVICE

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

MHRC camera

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)
• Healthy control subjects
• No clinical signs of dementia
• Telephone Mini-Mental State Examination score ≥ 25 or
• MoCA ≥ 26

You may not qualify if:

• 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

Sponsors & Collaborators

• Optina Diagnostics Inc.: lead
• McGill University: collaborator
• Sunnybrook Health Sciences Centre: collaborator

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Sandra Black, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will undergo 1) clinical characterization, 2) ophthalmic evaluation, 3) evaluation with the device (camera) and 4) brain imaging session (MRI + amyloid PET).

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: February 5, 2018
• Study Start: December 4, 2017
• Primary Completion: March 12, 2020
• Study Completion: March 12, 2020
• Last Updated: March 28, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)