Examining the effects of LEQEMBI on brain and eye amyloid in Alzheimer's patients
Proof of Concept of the Effect of LEQEMBI on Cerebral and Retinal Amyloid in Mild Cognitive Impairment Due to Alzheimer's Disease
This study is testing if the Alzheimer's treatment LEQEMBI can lower amyloid levels in the brain and eyes of patients with mild cognitive impairment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Sex | All |
| Sponsor | NeuroVision Imaging Industry-sponsored |
| Drugs / interventions | Lecanemab |
| Locations | 1 site (Sacramento, California) |
| Trial ID | NCT06400368 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the correlation between amyloid plaques in the brain and retinal findings in patients with mild cognitive impairment due to Alzheimer's disease. By utilizing amyloid brain PET imaging, MRI, and retinal imaging, the study will assess whether treatment with Lecanemab can lead to measurable reductions in amyloid levels in both the retina and brain. The goal is to understand the relationship between retinal amyloid and brain-related adverse effects, specifically ARIA, in patients receiving standard care with LEQEMBI.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 50 and older who are eligible for LEQEMBI treatment and can comply with the study protocol.
Not a fit: Patients with a history of acute angle-closure glaucoma or significant eye conditions that impair retinal imaging may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of Alzheimer's disease progression and improve monitoring of treatment effects through retinal imaging.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, making this a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Subjects must be eligible for and intend to receive LEQEMBI under standard of care treatment. 2. Male and female subjects ages ≥50 years old. 3. Must be willing to comply with protocol including pupillary dilation to a minimum of 3.5 mm to allow for ocular imaging. 4. 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. Exclusion Criteria: 1. History of acute angle-closure glaucoma or allergic reaction to the protocol-specified ophthalmic medication for dilation of the pupils. 2. Self-reported or diagnosed history of dense cataracts or other significant media opacity that may affect clear images of the retina. 3. Subjects must not have had eye surgery in the past 2 months, be currently administering eye drops relating to previous eye surgery, 4. Unable or unwilling to comply with the protocol requirements.
Where this trial is running
Sacramento, California
- Sutter Health — Sacramento, California, United States (Recruiting)
Study contacts
- Principal investigator: Shawn Kile, MD — Sutter Health
- Study coordinator: Mieko Chambers, MS
- Email: mchambers@neurovision.com
- Phone: 5305748449
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.