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Retinal Metabolic Imaging of Alzheimer Patient

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ClinicalTrials.gov Identifier: NCT03420807
Recruitment Status : Recruiting
First Posted : February 5, 2018
Last Update Posted : September 27, 2019
Sponsor:
Collaborators:
McGill University
Polytechnique Montreal
Sunnybrook Health Sciences Centre
Information provided by (Responsible Party):
Optina Diagnostics Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Device: MHRC Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Subjects will undergo 1) clinical characterization, 2) ophthalmic evaluation, 3) evaluation with the device (camera) and 4) brain imaging session (MRI + amyloid PET).
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Beta-amyloid Plaques of the Retina Using Metabolic Hyperspectral Retinal Camera (MHRC) in Alzheimer's Patients - Toronto Study Arm
Actual Study Start Date : December 4, 2017
Estimated Primary Completion Date : September 26, 2020
Estimated Study Completion Date : September 26, 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: MHRC camera
Subjects will undergo a retina imaging session with the MHRC camera.
 Device: MHRC
Evaluate the feasibility of detection of beta-amyloid plaques by using their spectral signature in autofluorescence or reflectance.


Outcome Measures
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Primary Outcome Measures :
  1. Retinal beta-amyloid detection [ Time Frame: Within 21 days following clinical characterization completion ]
    Presence of absence of beta-amyloid plaques in the retina


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03420807


Contacts
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Contact: David Lapointe 438-828-1675 dlapointe@optinadx.com
Contact: Anne-Marie Bedard 514-394-0797 ambedard@optinadx.com

Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Vito Losito    416-480-6100 ext 85479    vito.losito@sri.utoronto.ca   
Contact: Hossam Elshahawy    416-480-6100 ext 3497    hossam.elshahawy@sunnybrook.ca   
Principal Investigator: Sandra Black, MD         
Sub-Investigator: Mario Masellis, MD         
Sub-Investigator: Benjamin Lam, MD         
Sub-Investigator: Peter Kertes, MD         
Sub-Investigator: Natha Herrmann, MD         
Sub-Investigator: Sarah Sarah, MD         
Sponsors and Collaborators
Optina Diagnostics Inc.
McGill University
Polytechnique Montreal
Sunnybrook Health Sciences Centre
Investigators
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Principal Investigator: Sandra Black, MD Sunnybrook Health Sciences Centre
More Information
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Responsible Party: Optina Diagnostics Inc.
ClinicalTrials.gov Identifier: NCT03420807    
Other Study ID Numbers: 071317
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders