Status:
COMPLETED
Retinal Metabolic Imaging of Alzheimer Patient
Lead Sponsor:
Optina Diagnostics Inc.
Collaborating Sponsors:
McGill University
Sunnybrook Health Sciences Centre
Conditions:
Alzheimer Disease
Eligibility:
All Genders
50-90 years
Phase:
NA
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 hal...
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 mill...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 4 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 12 2020
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT03420807
Start Date
December 4 2017
End Date
March 12 2020
Last Update
March 28 2023
Active Locations (1)
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1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5