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

NCT06400368 | Recruiting

• 1 other identifier: 2023.128-1
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mild Cognitive Impairment; Alzheimer Disease

Keywords

retinal image; CAA; Leqembi; lecanamab

Outcome Measures

Primary Outcomes (1)

• 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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male and female subjects ages 50 and up eligible for treatment with LEQEMBI.

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.

Sponsors & Collaborators

• NeuroVision Imaging: lead

Study Sites (1)

Sutter Health

Sacramento, California, 95816, United States

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Study Officials

• Shawn Kile, MD

  Sutter Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mieko Chambers, MS

CONTACT

5305748449; mchambers@neurovision.com

Josef Tamory

CONTACT

jtamory@neurovision.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 6, 2024
• Study Start: April 24, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)