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Retinal Metabolic Imaging of Alzheimer Patient

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
MHRC
Sponsored by
Optina Diagnostics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Alzheimer Disease

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Sunnybrook Health Sciences Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MHRC camera

Arm Description

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

Outcomes

Primary Outcome Measures

Retinal beta-amyloid detection
Presence of absence of beta-amyloid plaques in the retina

Secondary Outcome Measures

Full Information

First Posted
January 29, 2018
Last Updated
March 24, 2023
Sponsor
Optina Diagnostics Inc.
Collaborators
McGill University, Sunnybrook Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT03420807
Brief Title
Retinal Metabolic Imaging of Alzheimer Patient
Official Title
Evaluation of Beta-amyloid Plaques of the Retina Using Metabolic Hyperspectral Retinal Camera (MHRC) in Alzheimer's Patients - Toronto Study Arm
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 4, 2017 (Actual)
Primary Completion Date
March 12, 2020 (Actual)
Study Completion Date
March 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Optina Diagnostics Inc.
Collaborators
McGill University, Sunnybrook Health Sciences Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MHRC camera
Arm Type
Experimental
Arm Description
Subjects will undergo a retina imaging session with the MHRC camera.
Intervention Type
Device
Intervention Name(s)
MHRC
Intervention Description
Evaluate the feasibility of detection of beta-amyloid plaques by using their spectral signature in autofluorescence or reflectance.
Primary Outcome Measure Information:
Title
Retinal beta-amyloid detection
Description
Presence of absence of beta-amyloid plaques in the retina
Time Frame
Within 21 days following clinical characterization completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra Black, MD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Retinal Metabolic Imaging of Alzheimer Patient

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