RECRUITINGOBSERVATIONAL
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
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
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 willing to sign a consent form and authorization to use protected health information (PHI) in accordance with national and local patient privacy regulations.
Who Should NOT Join This Trial:
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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Locations (1)
Sutter Health
Sacramento, California, United States