Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact
Clinical Trials in the USA / NCT07864623
Starting soon Observational

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

NCT07864623 · tracked via the Priya Life Science USA tracker
Sponsor
Eisai Inc
Phase
Observational
Started
2026-10-30
Last updated
2026-10-08

Condition(s) studied

Alzheimers Disease

Investigational drug(s) / intervention(s)

No Intervention

No Intervention: This is a non-interventional study.

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.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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: * 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

Primary outcome measure(s)

  • Change from Baseline in the CDR-SB — Baseline, 18 months

Trial sites (1)

FacilityCityRegionStatus
Eisai Trial Site #1 Nutley New Jersey

More Eisai Inc. trials in the USA

A Study to Assess Potential Drug-Drug Interactions of E2086 in Healthy Participants Recruiting
A Study to Assess the Pregnancy Outcome in Women Exposed to Dayvigo® During Pregnancy Compared to an Unexposed Control Population Active, not recruiting
A Study to Evaluate the Efficacy and Safety of E2086 in Adults With Narcolepsy Recruiting
A Study of E7386 in Combination With Other Anticancer Drug(s) in Participants With Solid Tumor Active, not recruiting
Study of E7386 in Participants With Selected Advanced Neoplasms Active, not recruiting

Other trials for the same condition

A Clinical Trial of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease Active, not recruiting
A Study of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease Active, not recruiting
Screening Study to Determine Individuals With Potential Trial Eligibility for Alzheimer's Disease Studies Recruiting
Brainshuttle AD: A Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7126209 Following Intravenous Infusion in Participants With Prodromal or Mild to Moderate Alzheimer's Disease Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07864623 on ClinicalTrials.gov ↗ ← All trials in the USA