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RecruitingNCT06400368Updated May 7, 2024

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

An observational study in Mild Cognitive Impairment and Alzheimer Disease, sponsored by NeuroVision Imaging. Recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2024-05-07.

Sponsored by NeuroVision Imaging · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2026, 6 months ago, but the record still lists the study as recruiting.
  • Started Apr 2024; still recruiting 2 years 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Sex
All
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Study 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.

Read the detailed 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.

02

Conditions studied

  • Mild Cognitive Impairment
  • Alzheimer Disease

Keywords

  • retinal image
  • CAA
  • Leqembi
  • lecanamab
03

In context

Alzheimer Disease

3,681 studies on the registry are indexed under Alzheimer Disease; 875 are open to participants now.

This study's planned enrollment of 200 is close to the median of 200 across 753 observational studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

This is the only study on the registry with NeuroVision Imaging as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
06

What researchers measure

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.

    Time frame: From enrollment to the end of the treatment at 1 year.

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06400368
Lead sponsor
NeuroVision Imaging
Responsible party
Sponsor
First posted
May 6, 2024
Start date
Apr 24, 2024
Primary completion
Apr 2026 (estimated)
Completion
Apr 2026 (estimated)
Last update
May 7, 2024

Study contacts

Mieko Chambers, MS
Contact
mchambers@neurovision.com
5305748449
Josef Tamory
Contact
jtamory@neurovision.com
Shawn Kile, MD
principal investigator · Sutter Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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