Alzheimer DiseaseNCT05215782
Eye to Brain Connection
An observational study of Alzheimer Disease, run by Optina Diagnostics Inc. at 1 site in United States.
Trial summary
This is a non-randomized, non-treatment, observational study designed to discover correlations between retinal imaging and amyloid PET imaging. Subjects will be recruited to the clinical cohort from referring physicians. Subjects may be participants from existing studies and clinical practices Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Alzheimer Disease
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2022to 16 Mar 2023
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Up to 100 adults between 50 and 90 years old, and undergoing evaluation for Alzheimer's Disease or other cognitive impairments will be recruited from the community. Patients will be asked if they would like to hear about a study related to better diagnostic tools for cognitive decline and dementias, which is seeking volunteers to undergo a non-invasive eye scan with a new type of camera. Informed consent will be obtained prior to enrollment in the study.
Who may be able to join
- Male and female adults aged 50 to 90 years (inclusive).
- Individuals with reported cognitive complaint (self or from an informant) under clinical investigation by a health professional for cognitive impairment where Alzheimer's disease (AD) is one of the differential diagnoses.
- Demonstrated cognitive impairment as evidenced by at least one of the following:
- Mini Mental State Examination (MMSE) score < 26/30
- Montreal Cognitive Assessment (MoCA) score < 26/30
- Score > 1 Standard Deviation below population mean on a standardized neuropsychological test, based on normative data from age-, sex-, education-, and where possible, race-matched peers [Based on guidelines for detecting Mild Cognitive Impairment due to AD (Albert et al., 2011)]
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- Cognitive impairment on the above test/s is unable to be fully explained by systemic, neurological or psychiatric disorders other than Alzheimer's disease.
- Capacity to give informed consent by patient or Legally Authorized Representative (LAR).
- Ability to undergo PET and MRI scans.
Who cannot join
- Any ophthalmologic condition that would prevent obtaining retinal imaging and/or could interfere with the analysis of the MHRC-C1 images by the CAS, including:
- Pupil dilation contraindicated (due to a pathology, or presence of 3 quadrants with Van Herick frading of 0 or 1 without iridotomy)
- Inadequate pupil dilatation (< 6mm diameter) preventing uniform illumination of the retina with the MHRC-C1
- Diagnosis of glaucoma or signs of glaucoma (excavation ratio ≥0.7)
- Signs of vascular occlusion or retinopathy (microaneurysm, exudate, hemorrhage or edema) within a diameter of 10 mm from the mid-point between the optic nerve head and the macula
- Presence of drusen and/or age-related macular degeneration (AREDS 9-step scale
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- 4 - cumulative drusen area diameter ≥ 250 um, pigmentary changes and cumulative drusen area diameter ≥ 63 um or pigmentary changes and cumulative geographic atrophy area diameter ≥ 354 um)
- Macular anomaly (e.g. macular hole, dystrophy, degeneration)
- Nuclear sclerosis > 2 (LOCS II four-point grading system) or presence of central cortical or central posterior subcapsular cataract
- Deficient visual fixation (inability to fixate for at least 2 s)
- Refractive error outside the range of -15 D to +15 D
- Corneal or media opacities (e.g. Weiss ring) affecting retinal imaging on a cumulative area > 1 disc area within a diameter of 10 mm from the mid-point between the optic nerve head and the macula (i.e. the area of interest for the MHRC-C1 imaging)
- Scar, atrophy, naevus, tumor, epiretinal membrane or retinal pucker with a cumulative area > 1 disc area within a diameter of 10 mm from the mid-point between the optic nerve head and the macula
- Papilledema
- Inability of obtaining at least 3 images of satisfactory quality with the MHRC-C1 per the Optina Diagnostics quality index software.
- Impossibility of obtaining a satisfactory quality amyloid-PET scan for interpretation by imaging specialists.
- Individuals currently enrolled in cerebral amyloid modifying medication studies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Optina Retina Scans to Detect the Likeley Cerebral Amyloid Status (CAS) as Determined by Prospective PET Imaging
This is a non-randomized, non-treatment, observational study designed to discover correlations between retinal imaging and amyloid PET imaging. Subjects will be recruited to the clinical cohort from referring physicians. Subjects may be participants from existing studies and clinical practices
- Conditions
- Alzheimer Disease
- Medical subject headings
- Alzheimer Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify features in the retinal hyperspectral images that strongly correlate with the cerebral Aβ plaque status (positive or negative) measured with amyloid PET imaging.
Measured: 1 year
Secondary outcomes (1)
Evaluate the classification performance of the Optina software to detect the likely cerebral amyloid status.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start14 Mar 2022
- Primary completion16 Mar 2023
- Study completion16 Mar 2023
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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Optina Diagnostics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ezy Medical Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05215782
- Sponsor's protocol ID
- DOC100681
- Status last verified
- Mar 2023
- First submitted
- 18 Jan 2022
- Last updated
- 24 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 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Optina Retina Scans to Detect the Likeley Cerebral Amyloid Status (CAS) as Determined by Prospective PET Imaging
- ClinicalTrials.gov ID
- NCT05215782
- Acronym / sponsor ID
- DOC100681
- Conditions
- Alzheimer Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Optina Diagnostics Inc.Industry (pharma, biotech, devices)
- Collaborators
- Ezy Medical Research
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 16 Mar 2023 (actual)
- Study completion
- 16 Mar 2023 (actual)
- First posted
- 31 Jan 2022 (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 is a non-randomized, non-treatment, observational study designed to discover correlations between retinal imaging and amyloid PET imaging. Subjects will be recruited to the clinical cohort from referring physicians. Subjects may be participants from existing studies and clinical practices
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 100 adults between 50 and 90 years old, and undergoing evaluation for Alzheimer's Disease or other cognitive impairments will be recruited from the community. Patients will be asked if they would like to hear about a study related to better diagnostic tools for cognitive decline and dementias, which is seeking volunteers to undergo a non-invasive eye scan with a new type of camera. Informed consent will be obtained prior to enrollment in the study.
Key inclusion criteria (9 listed)
- Male and female adults aged 50 to 90 years (inclusive).
- Individuals with reported cognitive complaint (self or from an informant) under clinical investigation by a health professional for cognitive impairment where Alzheimer's disease (AD) is one of the differential diagnoses.
- Demonstrated cognitive impairment as evidenced by at least one of the following:
- Cognitive impairment on the above test/s is unable to be fully explained by systemic, neurological or psychiatric disorders other than Alzheimer's disease.
- Capacity to give informed consent by patient or Legally Authorized Representative (LAR).
Key exclusion criteria (17 listed)
- Any ophthalmologic condition that would prevent obtaining retinal imaging and/or could interfere with the analysis of the MHRC-C1 images by the CAS, including:
- Inability of obtaining at least 3 images of satisfactory quality with the MHRC-C1 per the Optina Diagnostics quality index software.
- Impossibility of obtaining a satisfactory quality amyloid-PET scan for interpretation by imaging specialists.
- Individuals currently enrolled in cerebral amyloid modifying medication studies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To identify features in the retinal hyperspectral images that strongly correlate with the cerebral Aβ plaque status (positive or negative) measured with amyloid PET imaging.
Time frame: 1 year
1 secondary outcome
Evaluate the classification performance of the Optina software to detect the likely cerebral amyloid status.
Time frame: 1 year
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 24 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, run by Optina Diagnostics Inc. at 1 site in United States.
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 9 inclusion and 17 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 24 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 United States. 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?
To identify features in the retinal hyperspectral images that strongly correlate with the cerebral Aβ plaque status (positive or negative) measured with amyloid PET imaging. (time frame: 1 year). 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 24 Mar 2023.