MedPath

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)

AHEAD 3-45 Study: A Study to Evaluate Efficacy and Safety of Treatment With Lecanemab in Participants With Preclinical Alzheimer's Disease and Elevated Amyloid and Also in Participants With Early Preclinical Alzheimer's Disease and Intermediate Amyloid

Phase 3
Active, not recruiting
Conditions
Early Preclinical Alzheimer's Disease
Preclinical Alzheimer's Disease
Interventions
Drug: Placebo
First Posted Date
2020-07-13
Last Posted Date
2025-01-01
Lead Sponsor
Eisai Inc.
Target Recruit Count
1400
Registration Number
NCT04468659
Locations
🇺🇸

University of Alabama, Birmingham, Birmingham, Alabama, United States

🇺🇸

Banner Alzheimer's Institute, Phoenix, Arizona, United States

🇺🇸

Banner Sun Health Research Institute, Sun City, Arizona, United States

and more 102 locations

A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease

Phase 3
Active, not recruiting
Conditions
Early Alzheimer's Disease
Interventions
Drug: Placebo
First Posted Date
2019-03-25
Last Posted Date
2025-04-16
Lead Sponsor
Eisai Inc.
Target Recruit Count
1906
Registration Number
NCT03887455
Locations
🇺🇸

Emory University Cognitive Neurology Clinic & ADRC, Atlanta, Georgia, United States

🇺🇸

Brigham and Women's Hospital, Boston, Massachusetts, United States

🇺🇸

Ohio State University, Columbus, Ohio, United States

and more 232 locations

A Study to Evaluate Safety, Tolerability, and Efficacy of Lecanemab in Subjects With Early Alzheimer's Disease

Phase 2
Completed
Conditions
Alzheimer's Disease
Interventions
First Posted Date
2013-01-14
Last Posted Date
2025-01-22
Lead Sponsor
Eisai Inc.
Target Recruit Count
856
Registration Number
NCT01767311
Locations
🇬🇧

Facility #1, Swindon, United Kingdom

🇬🇧

Facility #2, London, United Kingdom

🇰🇷

Facility #4, Seoul, Korea, Republic of

and more 4 locations

Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation. Master Protocol DIAN-TU-001

Phase 2
Recruiting
Conditions
Alzheimers Disease
Dementia
Alzheimers Disease, Familial
Interventions
Drug: Matching Placebo (Gantenerumab)
Drug: Matching Placebo (Solanezumab)
Drug: Matching Placebo (E2814)
First Posted Date
2013-01-03
Last Posted Date
2025-04-03
Lead Sponsor
Washington University School of Medicine
Target Recruit Count
490
Registration Number
NCT01760005
Locations
🇨🇦

UBC Hospital, Vancouver, British Columbia, Canada

🇺🇸

University of Washington, Seattle, Washington, United States

🇫🇷

CHU de Rouen - Hôpital Charles Nicolle, Rouen, Seine Maritime, France

and more 35 locations
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