NCT06400368

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: NeuroVision Imaging · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

Based upon studies and histological evidence, investigators and study sponsor suspects that the primary mechanism that causes CAA in the brain (and increased risk of ARIA) may also occur in the retina. Investigators propose use of both amyloid brain PET imaging, MRI, and retinal imaging to determine if patients undergoing Lecanemab treatment allows for in the ability to correlate ARIA from retinal amyloid and vasculature versus MRI criteria, and a measurable reduction in amyloid in the retina when compared with amyloid PET scans of the brain post-treatment.

Conditions

• Mild Cognitive Impairment
• Alzheimer Disease

Timeline

• Start date: 2024-04-24
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2024-05-06
• Last updated: 2024-05-07

Locations

1 site across 1 country: United States