CClinicalTrials.gg
Not yet recruitingNCT07864623Updated Oct 8, 2026

A Postmarketing Study of LEQEMBI in Participants With Alzheimer's Disease

An observational study in Alzheimers Disease, sponsored by Eisai Inc.. Not yet recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-10-08.

Sponsored by Eisai Inc. · Observational

Updated Oct 8, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
270
Sex
All
01

Study summary

The primary purpose of this study is to evaluate the efficacy of LEQEMBI in participants with early Alzheimer's disease (AD) indicated per Canada Product Monograph (APOE4 non-carriers and heterozygotes; indicated population) compared with placebo (PBO)-treated participants from BAN2401-G000-301 (Study 301) Core study on change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 18 months of treatment.

Read the detailed description

This is a non-interventional study using real-world retrospective efficacy (CDR-SB) data from prescribing institutions in North America to evaluate the efficacy of LEQEMBI.

As this is a Retrospective Database Study, the Study Start Date for this study references the date at which the first set of data will become available.

02

Conditions studied

  • Alzheimers Disease

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Keywords

  • Early Alzheimer's disease
  • LEQEMBI
03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's planned enrollment of 270 is above the median of 200 across 751 observational studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Eisai Inc. is the lead sponsor of 361 studies on the registry; 8 are open to participants now.

Of its 81 completed or terminated interventional studies of FDA-regulated products, 54 (67%) have results posted.

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

04

Who can participate

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

Study population

Participants with early Alzheimer's Disease treated with lecanemab will be observed retrospectively.

Inclusion criteria

  • Participant (or legally authorized representative) has provided written informed consent to participate in the local site registry
  • Mild cognitive impairment (MCI) due to AD or mild AD dementia, according to the National Institute on Aging - Alzheimer's Association (NIA-AA) criteria
  • Global CDR at baseline of 0.5 or 1
  • APOE4 heterozygous or noncarrier
  • Have had a baseline CDR-SB (before initiation of LEQEMBI treatment)
  • Completed 18 months of LEQEMBI treatment, with an 18-month CDR-SB assessment

Exclusion criteria

Exclusion Criteria:

  • Use of any other anti-amyloid treatment prior to and during the 18-month LEQEMBI treatment period
  • Conditions highlighted under "Contraindications" section in the Canadian Product Monograph
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
270 participants (estimated)
Patient registry
No

Groups and cohorts

  • Participants Treated With Lecanemab

    Other: No Intervention

Interventions

  • OtherNo Intervention

    This is a non-interventional study.

06

What researchers measure

Primary outcomes

  1. Change from Baseline in the CDR-SB

    Time frame: Baseline, 18 months

Secondary outcomes

  1. Time to Progression to the Next Stage of Alzheimer's Disease as Assessed by Global CDR Score

    Time frame: Baseline, 18 months

07

Study locations

1 site
  • Eisai Trial Site #1
    Nutley, New Jersey 07110, United States
08

References and documents

Individual participant data

Plan to share: Yes — Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 8, 2026
Show all 1 update
  1. Oct 8, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07864623
Lead sponsor
Eisai Inc.
Responsible party
Sponsor
First posted
Oct 8, 2026
Start date
Oct 30, 2026 (estimated)
Primary completion
Aug 31, 2029 (estimated)
Completion
Aug 31, 2029 (estimated)
Last update
Oct 8, 2026

Study contacts

Eisai Medical Information Eisai Inc.
Contact
esi_medinfo@eisai.com
+1-888-274-2378

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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