RecruitingNCT06400368

Effect of LEQEMBI on Cerebral and Retinal Amyloid in Mild Cognitive Impairment Due to Alzheimer's Disease

Proof of Concept of the Effect of LEQEMBI on Cerebral and Retinal Amyloid in Mild Cognitive Impairment Due to Alzheimer's Disease

Sponsor

NeuroVision Imaging

Enrollment

200 participants

Start Date

Apr 24, 2024

Study Type

OBSERVATIONAL

Conditions

Alzheimer Disease Mild Cognitive Impairment

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.

Eligibility

Inclusion Criteria4

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.

Exclusion Criteria4

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.