Last updated: May 3, 2024
Sponsor: NeuroVision Imaging
Overall Status: Active - Recruiting
Phase
N/A
Condition
Mild Cognitive Impairment
Dementia
Alzheimer's Disease
Treatment
N/AClinical Study ID
NCT06400368
2023.128-1
All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Subjects must be eligible for and intend to receive LEQEMBI under standard of caretreatment.
- 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 legalguardian) has the ability to understand the purpose and risks of the study and providesigned and dated informed consent and authorization to use protected healthinformation (PHI) in accordance with national and local patient privacy regulations.
Exclusion
Exclusion Criteria:
- History of acute angle-closure glaucoma or allergic reaction to the protocol-specifiedophthalmic medication for dilation of the pupils.
- Self-reported or diagnosed history of dense cataracts or other significant mediaopacity that may affect clear images of the retina.
- Subjects must not have had eye surgery in the past 2 months, be currentlyadministering eye drops relating to previous eye surgery,
- Unable or unwilling to comply with the protocol requirements.
Study Design
Total Participants: 200
Study Start date:
April 24, 2024
Estimated Completion Date:
April 30, 2026
Study Description
Connect with a study center
Sutter Health
Sacramento, California 95816
United StatesActive - Recruiting
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