Alzheimer DiseaseNCT03420807
Retinal Metabolic Imaging of Alzheimer Patient
A study testing MHRC in people with Alzheimer Disease, run by Optina Diagnostics Inc. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- MHRC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteCanada
- Study dates
- 4 Dec 2017to 12 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Beta-amyloid Plaques of the Retina Using Metabolic Hyperspectral Retinal Camera (MHRC) in Alzheimer's Patients - Toronto Study Arm
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.
Read the 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
- Being tested
- MHRC
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MHRCDevice
Evaluate the feasibility of detection of beta-amyloid plaques by using their spectral signature in autofluorescence or reflectance.
| Study group | Role | What they receive |
|---|---|---|
| MHRC camera | Experimental | Subjects will undergo a retina imaging session with the MHRC camera. Receives: Device: MHRC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal beta-amyloid detection
Presence of absence of beta-amyloid plaques in the retina
Measured: Within 21 days following clinical characterization completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start4 Dec 2017
- Primary completion12 Mar 2020
- Study completion12 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Optina Diagnostics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- McGill University, Sunnybrook Health Sciences Centre
- Responsible party
- Sponsor
- Investigators
- Sandra Black, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03420807
- Sponsor's protocol ID
- 071317
- Status last verified
- Mar 2023
- First submitted
- 29 Jan 2018
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Beta-amyloid Plaques of the Retina Using Metabolic Hyperspectral Retinal Camera (MHRC) in Alzheimer's Patients - Toronto Study Arm
- ClinicalTrials.gov ID
- NCT03420807
- Acronym / sponsor ID
- 071317
- Conditions
- Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Optina Diagnostics Inc.Industry (pharma, biotech, devices)
- Collaborators
- McGill University, Sunnybrook Health Sciences Centre
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 12 Mar 2020 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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).
| Arm | Type | Receives |
|---|---|---|
| MHRC camera | Experimental | Device: MHRCSubjects will undergo a retina imaging session with the MHRC camera. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Subjects with Alzheimer's disease
- Subjects with Mild Cognitive Impairment
- Healthy control subjects
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MHRCEvaluate the feasibility of detection of beta-amyloid plaques by using their spectral signature in autofluorescence or reflectance. | Device | MHRC camera |
Primary outcome
Retinal beta-amyloid detection
Time frame: Within 21 days following clinical characterization completion
Presence of absence of beta-amyloid plaques in the retina
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra Black, MD principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MHRC in people with Alzheimer Disease, run by Optina Diagnostics Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal beta-amyloid detection (time frame: Within 21 days following clinical characterization completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.