RECRUITING

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

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Conditions

Mild Cognitive ImpairmentAlzheimer Diseaseretinal imageCAALeqembilecanamab

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-04-24
Study Completion:2026-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06400368

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Subjects must be eligible for and intend to receive LEQEMBI under standard of care treatment.
  2. 2. Male and female subjects ages ≥50 years old.
  3. 3. Must be willing to comply with protocol including pupillary dilation to a minimum of 3.5 mm to allow for ocular imaging.
  4. 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.
  1. 1. History of acute angle-closure glaucoma or allergic reaction to the protocol-specified ophthalmic medication for dilation of the pupils.
  2. 2. Self-reported or diagnosed history of dense cataracts or other significant media opacity that may affect clear images of the retina.
  3. 3. Subjects must not have had eye surgery in the past 2 months, be currently administering eye drops relating to previous eye surgery,
  4. 4. Unable or unwilling to comply with the protocol requirements.

Contacts and Locations

Study Contact

Mieko Chambers, MS
CONTACT
5305748449
mchambers@neurovision.com
Josef Tamory
CONTACT
jtamory@neurovision.com

Principal Investigator

Shawn Kile, MD
PRINCIPAL_INVESTIGATOR
Sutter Health

Study Locations (Sites)

Sutter Health
Sacramento, California, 95816
United States

Collaborators and Investigators

Sponsor: NeuroVision Imaging

  • Shawn Kile, MD, PRINCIPAL_INVESTIGATOR, Sutter Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-24
Study Completion Date2026-04

Study Record Updates

Study Start Date2024-04-24
Study Completion Date2026-04

Terms related to this study

Keywords Provided by Researchers

  • retinal image
  • CAA
  • Leqembi
  • lecanamab

Additional Relevant MeSH Terms

  • Mild Cognitive Impairment
  • Alzheimer Disease