Recruiting

LEQEMBI

Sponsor:

NeuroVision Imaging

Code:

NCT06400368

Conditions

Mild Cognitive Impairment

Alzheimer Disease

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT06400368

Start date

Apr 24, 2024

Status verified date

May, 2024

Completion date

Apr, 2026

Anticipated

Primary completion date

Apr, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not 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.

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Investigational and Research- retinal vessel and tortuosity [ Time Frame: From enrollment to the end of the treatment at 1 year. ]

Central Contacts and Locations

Central contacts

Locations

Sutter Health

Recruiting

Sacramento, California, United States, 95816

Contacts

More Information

Sponsor

NeuroVision Imaging

Last update posted

May 7, 2024

Last verified

May, 2024

Keywords

  • retinal image
  • CAA
  • Leqembi
  • lecanamab

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NeuroVision Imaging on 2024-05-07.