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

Status unconfirmed

Conditions studied: Mild Cognitive Impairment, Alzheimer Disease

In brief

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.

Key facts

Study ID

NCT06400368

Run by

NeuroVision Imaging

People needed

200

Starts

2024-04-24

Expected to finish

2026-04-01

Last updated by the study team

2024-05-07

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Sutter Health — Sacramento, California, United States (enrolling)

Full record on ClinicalTrials.gov

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