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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06400368
• Other study ID #: 2023.128-1
• Status: Recruiting
• Start date: April 24, 2024
• Est. completion date: April 2026

Study information

• Verified date: May 2024
• Source: NeuroVision Imaging
• Contact: Mieko Chambers, MS
• Phone: 5305748449
• Email: mchambers[@]neurovision.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Mild Cognitive Impairment

Locations

Country	Name	City	State
United States	Sutter Health	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
NeuroVision Imaging

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigational and Research- retinal vessel and tortuosity	Measurements of amyloid levels in the retina based on autoflourescence imaging, retinal vessel and tortuosity.	From enrollment to the end of the treatment at 1 year.