Mild Cognitive ImpairmentNCT06400368
Effect of LEQEMBI on Cerebral and Retinal Amyloid in Mild Cognitive Impairment Due to Alzheimer's Disease
An observational study of Mild Cognitive Impairment and Alzheimer Disease, run by NeuroVision Imaging at 1 site in United States.
Trial summary
This is a proof of concept observational study is to determine if there is correlation between Aβ plaques and vascular findings in the Retina versus brain ARIA. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer Disease
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2024to Apr 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Male and female subjects ages 50 and up eligible for treatment with LEQEMBI.
Who may be able to join
- Subjects must be eligible for and intend to receive LEQEMBI under standard of care treatment.
- Male and female subjects ages ≥50 years old.
- Must be willing to comply with protocol including pupillary dilation to a minimum of 3.5 mm to allow for ocular imaging.
- Patient or patient's legally authorized representative (LAR) (e.g., spouse or legal guardian) has the ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local patient privacy regulations.
Who cannot join
- History of acute angle-closure glaucoma or allergic reaction to the protocol-specified ophthalmic medication for dilation of the pupils.
- Self-reported or diagnosed history of dense cataracts or other significant media opacity that may affect clear images of the retina.
- Subjects must not have had eye surgery in the past 2 months, be currently administering eye drops relating to previous eye surgery,
- Unable or unwilling to comply with the protocol requirements.
Trial locations and contacts
1 site in 1 country.
Josef Tamory contact
United States1 site, 1 recruiting
- Recruiting
Sutter Health
Sacramento, California, 95816
Dawn Lenakakis, dawn.lekakis@sutterhealth.org
About this study
Official title: Proof of Concept of the Effect of LEQEMBI on Cerebral and Retinal Amyloid in Mild Cognitive Impairment Due to Alzheimer's Disease
This is a proof of concept observational study is to determine if there is correlation between Aβ plaques and vascular findings in the Retina versus brain ARIA.
Read the detailed description
Based upon studies and histological evidence, investigators and study sponsor suspects that the primary mechanism that causes CAA in the brain (and increased risk of ARIA) may also occur in the retina. Investigators propose use of both amyloid brain PET imaging, MRI, and retinal imaging to determine if patients undergoing Lecanemab treatment allows for in the ability to correlate ARIA from retinal amyloid and vasculature versus MRI criteria, and a measurable reduction in amyloid in the retina when compared with amyloid PET scans of the brain post-treatment.
- Conditions
- Mild Cognitive Impairment, Alzheimer Disease
- Keywords
- retinal image, CAA, Leqembi, lecanamab
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigational and Research- retinal vessel and tortuosity
Measurements of amyloid levels in the retina based on autoflourescence imaging, retinal vessel and tortuosity.
Measured: From enrollment to the end of the treatment at 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start24 Apr 2024
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NeuroVision Imaging
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shawn Kile, MD, Principal investigator, Sutter Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400368
- Sponsor's protocol ID
- 2023.128-1
- Status last verified
- May 2024
- First submitted
- 29 Apr 2024
- Last updated
- 7 May 2024
- 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 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof of Concept of the Effect of LEQEMBI on Cerebral and Retinal Amyloid in Mild Cognitive Impairment Due to Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT06400368
- Acronym / sponsor ID
- 2023.128-1
- Conditions
- Mild Cognitive Impairment, Alzheimer Disease
- Keywords
- retinal image, CAA, Leqembi, lecanamab
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- NeuroVision ImagingIndustry (pharma, biotech, devices)
- Study start
- 24 Apr 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 6 May 2024 (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 proof of concept observational study is to determine if there is correlation between Aβ plaques and vascular findings in the Retina versus brain ARIA.
Detailed description
Based upon studies and histological evidence, investigators and study sponsor suspects that the primary mechanism that causes CAA in the brain (and increased risk of ARIA) may also occur in the retina. Investigators propose use of both amyloid brain PET imaging, MRI, and retinal imaging to determine if patients undergoing Lecanemab treatment allows for in the ability to correlate ARIA from retinal amyloid and vasculature versus MRI criteria, and a measurable reduction in amyloid in the retina when compared with amyloid PET scans of the brain post-treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Male and female subjects ages 50 and up eligible for treatment with LEQEMBI.
Key inclusion criteria (4 listed)
- Subjects must be eligible for and intend to receive LEQEMBI under standard of care treatment.
- Male and female subjects ages ≥50 years old.
- Must be willing to comply with protocol including pupillary dilation to a minimum of 3.5 mm to allow for ocular imaging.
- Patient or patient's legally authorized representative (LAR) (e.g., spouse or legal guardian) has the ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local patient privacy regulations.
Key exclusion criteria (4 listed)
- History of acute angle-closure glaucoma or allergic reaction to the protocol-specified ophthalmic medication for dilation of the pupils.
- Self-reported or diagnosed history of dense cataracts or other significant media opacity that may affect clear images of the retina.
- Subjects must not have had eye surgery in the past 2 months, be currently administering eye drops relating to previous eye surgery,
- Unable or unwilling to comply with the protocol requirements.
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
Investigational and Research- retinal vessel and tortuosity
Time frame: From enrollment to the end of the treatment at 1 year.
Measurements of amyloid levels in the retina based on autoflourescence imaging, retinal vessel and tortuosity.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- 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.
Josef Tamory contact
Shawn Kile, MD principal investigator
Sutter Health
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 Mild Cognitive Impairment and Alzheimer Disease, run by NeuroVision Imaging 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 7 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mieko Chambers, MS (5305748449, mchambers@neurovision.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigational and Research- retinal vessel and tortuosity (time frame: From enrollment to the end of the treatment at 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 7 May 2024.