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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-24

Study Completion Date

2026-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of LY2886721 in Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease

NCT01561430

Alzheimer's Disease

TERMINATED PHASE1/PHASE2

A Post Marketing Study in Participants With Early Alzheimer's Disease Treated With Lecanemab

NCT06322667

Alzheimer's Disease

RECRUITING

Lecanemab for Early Onset Familial Alzheimer's Disease

NCT06883019

Alzheimer Disease

RECRUITING

The Clinical Study of Synaptic Plasticity-based Lencanumab for the Treatment of Early Alzheimer's Disease

NCT06871839

Alzheimer's Disease Lecanemab Functional Magnetic Resonance Imaging

RECRUITING

Feasibility of Lecanemab Registry and Clinical Outcome Measures

NCT06285448

Alzheimer Disease

ENROLLING_BY_INVITATION

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Mild Cognitive Impairment Alzheimer Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No