Lecanemab
- Generic Name
- Lecanemab
- Brand Names
- Leqembi
- Drug Type
- Biotech
- CAS Number
- 1260393-98-3
- Unique Ingredient Identifier
- 12PYH0FTU9
- Background
Lecanemab is a recombinant humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta (Aβ), which are implicated in the pathophysiology of Alzheimer’s disease. Lecanemab works to reduce Aβ plaques and prevent Aβ deposition in the brain with high selectivity to Aβ protofibrils. In clinical trials, it significantly reduced brain Aβ plaques compared to placebo.
On January 6, 2023, lecanemab was granted accelerated approval by the FDA for the treatment of Alzheimer’s Disease. It was granted full FDA approval on July 6, 2023.
- Indication
Lecanemab is indicated for the treatment of Alzheimer’s disease. Treatment with lecanemab should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.
- Associated Conditions
- Alzheimer's Disease (AD)
Prospective Cohort Study of Patients with Early Alzheimer's Disease Treated with Lecanemab
- Conditions
- Alzheimer DiseaseMild Cognitive Impairment (MCI)
- Interventions
- First Posted Date
- 2024-12-19
- Last Posted Date
- 2024-12-19
- Lead Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Target Recruit Count
- 120
- Registration Number
- NCT06741553
- Locations
- 🇨🇳
Affiliated Hospital, School of Medicine, Zhejiang University, China, Hangzhou, Zhejiang, China
A Study of E2814 With Concurrent Lecanemab Treatment in Participants With Early Alzheimer's Disease
- First Posted Date
- 2024-09-19
- Last Posted Date
- 2025-04-03
- Lead Sponsor
- Eisai Inc.
- Target Recruit Count
- 90
- Registration Number
- NCT06602258
- Locations
- 🇺🇸
Advanced Memory Research Institute, Toms River, New Jersey, United States
🇺🇸Banner Sun Health Research Institute, Sun City, Arizona, United States
🇺🇸Sharp Neurocognitive Research Center at Sharp Mesa Vista Hospital, San Diego, California, United States
Deep Cervical Lymphatlc-Venous Anastomosis Surgery for the Treatment of Alzheimer's Disease: A Pilot Study (DIVA Study)
- Conditions
- Alzheimer's Disease
- Interventions
- Procedure: Deep Cervical lymphatlc-Venous Anastomosis Surgery
- First Posted Date
- 2024-07-31
- Last Posted Date
- 2025-01-16
- Lead Sponsor
- Zhejiang Provincial People's Hospital
- Target Recruit Count
- 60
- Registration Number
- NCT06530732
- Locations
- 🇨🇳
Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, China
DIAN-TU Amyloid Removal Trial (ART) in Dominantly Inherited Alzheimer's Disease
- Conditions
- DementiaAlzheimer's Disease, FamilialAlzheimer's Disease
- Interventions
- First Posted Date
- 2024-04-25
- Last Posted Date
- 2025-04-03
- Lead Sponsor
- Washington University School of Medicine
- Target Recruit Count
- 65
- Registration Number
- NCT06384573
- Locations
- 🇺🇸
University of Alabama in Birmingham, Birmingham, Alabama, United States
🇺🇸Indiana University School of Medicine, Indianapolis, Indiana, United States
🇺🇸Washington University in St. Louis, Saint Louis, Missouri, United States
Feasibility of Lecanemab Registry and Clinical Outcome Measures
- Conditions
- Alzheimer Disease
- Interventions
- First Posted Date
- 2024-02-29
- Last Posted Date
- 2025-01-24
- Lead Sponsor
- HealthPartners Institute
- Target Recruit Count
- 20
- Registration Number
- NCT06285448
- Locations
- 🇺🇸
HealthPartners Neuroscience Center, Saint Paul, Minnesota, United States
Cognitive Neurology Unit Clinical Registry
- First Posted Date
- 2023-06-29
- Last Posted Date
- 2025-02-05
- Lead Sponsor
- Beth Israel Deaconess Medical Center
- Target Recruit Count
- 500
- Registration Number
- NCT05925621
- Locations
- 🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
A Study to Demonstrate the Bioequivalence of Lecanemab Supplied in Vials and a Single-Use Auto-Injector (AI) in Healthy Participants
- First Posted Date
- 2022-09-09
- Last Posted Date
- 2023-01-18
- Lead Sponsor
- Eisai Inc.
- Target Recruit Count
- 160
- Registration Number
- NCT05533801
- Locations
- 🇺🇸
Anaheim Clinical Trials, Anaheim, California, United States
Safety and Feasibility of Exablate Blood-Brain Barrier Disruption for Mild Cognitive Impairment or Mild Alzheimer's Disease Undergoing Standard of Care Monoclonal Antibody (mAb) Therapy
- Conditions
- Mild Cognitive ImpairmentAlzheimer Disease 1
- Interventions
- First Posted Date
- 2022-07-21
- Last Posted Date
- 2025-03-24
- Lead Sponsor
- Ali Rezai
- Target Recruit Count
- 15
- Registration Number
- NCT05469009
- Locations
- 🇺🇸
West Virginia University Rockefeller Neuroscience Institute, Morgantown, West Virginia, United States
Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation (DIAN-TU)
- Conditions
- Alzheimers DiseaseDementiaAlzheimers Disease, Familial
- Interventions
- First Posted Date
- 2022-03-08
- Last Posted Date
- 2025-04-03
- Lead Sponsor
- Washington University School of Medicine
- Target Recruit Count
- 197
- Registration Number
- NCT05269394
- Locations
- 🇺🇸
Emory University, Atlanta, Georgia, United States
🇺🇸USC Keck School of Medicine, Los Angeles, California, United States
🇨🇴Grupo de Neurociencias Sede de la Universidad de Antioquia, Medellín, Colombia
A Study of Subcutaneous Lecanemab in Healthy Participants
- First Posted Date
- 2021-09-16
- Last Posted Date
- 2022-01-19
- Lead Sponsor
- Eisai Inc.
- Target Recruit Count
- 60
- Registration Number
- NCT05045716
- Locations
- 🇺🇸
Anaheim Clinical Trials, Anaheim, California, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.