1400 Participants Needed

Lecanemab for Alzheimer's Disease

Recruiting at 47 trial locations
EM
AR
Overseen ByACTC Recruitment Unit
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing lecanemab, a drug aimed at improving memory and thinking skills in people with early signs of Alzheimer's disease. The drug works by reducing amyloid plaques in the brain, which are believed to contribute to Alzheimer's. Researchers want to see if lecanemab is effective over several years.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that taking certain prohibited medications may exclude you from participating. It's best to discuss your current medications with the trial team to see if they are allowed.

Is Lecanemab safe for humans?

Lecanemab has been studied for safety in people with Alzheimer's disease, and while it has shown some effectiveness in reducing brain amyloid-β, the safety data is primarily available for this condition. It is important to discuss with a healthcare provider to understand the potential risks and benefits for your specific situation.12345

What makes the drug lecanemab unique for treating Alzheimer's disease?

Lecanemab is unique because it is a humanized antibody that targets and clears amyloid-β, a protein linked to Alzheimer's, and is specifically approved for early stages of the disease. It has shown to reduce brain amyloid-β and slow cognitive decline in patients with mild cognitive impairment or mild dementia.12345

What data supports the effectiveness of the drug Lecanemab for Alzheimer's disease?

Research shows that Lecanemab helps clear amyloid-β (a protein linked to Alzheimer's) from the brain and slows down memory and thinking problems in people with early Alzheimer's disease.12345

Are You a Good Fit for This Trial?

This trial is for men and women aged 55-80 with early signs of Alzheimer's, indicated by certain levels of brain amyloid. Participants must have a good memory score and be generally healthy without severe psychiatric issues or recent drug/alcohol abuse. Women who are pregnant or breastfeeding, people sensitive to monoclonal antibodies, HIV positive individuals, those with uncontrolled bleeding disorders or immunological diseases can't join.

Inclusion Criteria

A45 Trial: Elevated brain amyloid pathology by amyloid PET: defined as approximately greater than (>) 40 Centiloids on screening scan A3 Trial: Intermediate levels of brain amyloid pathology by amyloid PET: defined as approximately 20 to 40 Centiloids on screening scan
I have someone who knows about my daily activities and can share this information with the study team.
Mini Mental State Examination score greater than or equal to (>=) 27 (with educational adjustments) at screening.
See 12 more

Exclusion Criteria

I am using or agree to use birth control as required.
You have any other health problems that, according to the doctor's opinion, need more attention or treatment and may interfere with the study or your safety.
Known or suspected history of drug or alcohol abuse or dependence within 2 years before screening or a positive urine drug test at screening. Participants who test positive for benzodiazepines, opioids, or tetrahydrocannabinol (THC) in urine drug testing need not be excluded unless in the clinical opinion of the investigator this is due to potential drug abuse
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive lecanemab or placebo as IV infusion every two to four weeks for 216 weeks

216 weeks
Every two to four weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Extension

Participants may continue to receive lecanemab in an extension phase for up to 312 weeks

96 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Lecanemab
  • Placebo
Trial Overview The study tests if Lecanemab can slow cognitive decline better than a placebo over 216 weeks in people with preclinical Alzheimer's disease. It also checks if Lecanemab reduces brain amyloid accumulation more effectively than the placebo.
How Is the Trial Designed?
6Treatment groups
Experimental Treatment
Placebo Group
Group I: A45 Trial: Lecanemab 5 mg/kg + 10 mg/kg (Core Study)Experimental Treatment1 Intervention
Participants will receive lecanemab 5 milligram per kilogram (mg/kg), administered as intravenous (IV) infusion, every two weeks from Week 0 to 6, then 10 mg/kg, administered as IV infusion, every two weeks from Week 8 to 94, and 10 mg/kg, administered as IV infusion, every four weeks from Week 96 to 216 in core study.
Group II: A45 Trial: Lecanemab 10 mg/kg (Extension Phase)Experimental Treatment1 Intervention
Participants progressing to early Alzheimer's disease (EAD) during the core study (progressors) will receive lecanemab 10 mg/kg, administered as IV infusion, every two weeks after transition to the extension phase through to at least Week 216 from randomization in the core study. Participants completing the core study (completers) will enter extension phase and will receive lecanemab 10 mg/kg, administered as IV infusion, every two weeks for up to Week 312. Eligible participants receiving placebo in core study will continue to extension phase.
Group III: A3 Trial: Lecanemab 5 mg/kg + 10 mg/kg (Core Study)Experimental Treatment1 Intervention
Participants will receive lecanemab 5 mg/kg, administered as IV infusion, every four weeks from Week 0 to 4, then 10 mg/kg, administered as IV infusion, every four weeks from Week 8 to 216 in core study.
Group IV: A3 Trial: Lecanemab 10 mg/kg (Extension Phase)Experimental Treatment1 Intervention
Participants progressing to EAD during the core study (progressors) will receive lecanemab 10 mg/kg, administered as IV infusion, every two weeks after transition to the extension phase through to at least Week 216 from randomization in the core study. Participants completing the core study (completers) will enter extension phase and will receive lecanemab 10 mg/kg, administered as IV infusion, every two weeks for up to Week 312. Eligible participants receiving placebo in core study will continue to extension phase.
Group V: A45 Trial: Placebo (Core Study)Placebo Group1 Intervention
Participants will receive placebo (0.9 percent \[%\] sodium chloride solution), administered as IV infusion, every two weeks from Week 0 to 94, then every four weeks from Week 96 to 216.
Group VI: A3 Trial: Placebo (Core Study)Placebo Group1 Intervention
Participants will receive placebo (0.9% sodium chloride solution), administered as IV infusion, every four weeks from Week 0 to 216.

Lecanemab is already approved in United States, Japan for the following indications:

🇺🇸
Approved in United States as Leqembi for:
  • Early symptomatic Alzheimer's disease
🇯🇵
Approved in Japan as Leqembi for:
  • Early symptomatic Alzheimer's disease

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eisai Inc.

Lead Sponsor

Trials
524
Recruited
161,000+
Founded
Eisai Inc. was established in 1995 as the U.S. subsidiary of Eisai Co., Ltd.
Headquarters
Woodcliff Lake, NJ, USA
Known For
Neurology and Oncology
Top Products
Aricept (donepezil), Lenvima (lenvatinib), Leqembi (lecanemab), Halaven (eribulin)
Lynn Kramer profile image

Lynn Kramer

Eisai Inc.

Chief Medical Officer since 2019

MD

Tatsuyuki Yasuno profile image

Tatsuyuki Yasuno

Eisai Inc.

Chief Executive Officer since 2023

MBA from Kellogg School of Management, Northwestern University; Bachelor of Political Science from Waseda University

Biogen

Industry Sponsor

Trials
655
Recruited
468,000+
Daniel Quirk profile image

Daniel Quirk

Biogen

Chief Medical Officer

MD

Christopher A. Viehbacher profile image

Christopher A. Viehbacher

Biogen

Chief Executive Officer since 2022

Graduated from Queen's University, Kingston, Ontario, Canada

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Alzheimer's Clinical Trials Consortium

Collaborator

Trials
5
Recruited
2,800+

Published Research Related to This Trial

In an 18-month double-blind randomized placebo-controlled trial, lecanemab was effective in clearing amyloid-β in two-thirds of participants with mild cognitive impairment and mild dementia due to Alzheimer's disease.
Lecanemab also significantly reduced the rate of cognitive and functional decline in these individuals, suggesting its potential as a therapeutic intervention for early Alzheimer's disease.
Lecanemab reduces brain amyloid-β and delays cognitive worsening.Knopman, DS.[2023]
Lecanemab, a humanized monoclonal antibody, significantly reduces brain amyloid levels and leads to moderate improvements in cognitive function in Alzheimer's patients, as shown in the Clarity AD phase III trial with 18 months of treatment.
While lecanemab demonstrates efficacy in slowing cognitive decline, it is associated with adverse events such as infusion-related reactions (26.4%) and amyloid-related imaging abnormalities (12.6%), raising concerns about its administration and monitoring requirements.
Lecanemab: A Humanized Monoclonal Antibody for the Treatment of Early Alzheimer Disease.Park, J., Simpson, C., Patel, K.[2023]
Lecanemab has shown promise in treating early Alzheimer's disease, demonstrating a significant reduction in clinical decline among participants in the study.
The study involved a large cohort, providing robust evidence for lecanemab's efficacy, although specific details on the number of subjects and duration were not provided in the overview.
Evidence for lecanemab in early Alzheimer's disease.[2023]

Citations

Lecanemab reduces brain amyloid-β and delays cognitive worsening. [2023]
Lecanemab: A Humanized Monoclonal Antibody for the Treatment of Early Alzheimer Disease. [2023]
Evidence for lecanemab in early Alzheimer's disease. [2023]
Lecanemab: First Approval. [2023]
Safety and efficacy of lecanemab for Alzheimer's disease: a systematic review and meta-analysis of randomized clinical trials. [2023]
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