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Monoclonal Antibodies
Lecanemab for Alzheimer's Disease
Phase 3
Recruiting
Research Sponsored by Eisai Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female, age 55 to 80 years inclusive at the time of informed consent, with a plasma biomarker result that is predictive of intermediate or elevated brain amyloid at Screening or known before Screening to have elevated or intermediate amyloid according to previous PET, cerebrospinal fluid (CSF), or plasma testing
Male or female, age 55 to 80 years inclusive at the time of informed consent, with a plasma biomarker result that is predictive of intermediate or elevated brain amyloid at Screening or known before Screening to have elevated or intermediate amyloid according to previous PET, cerebrospinal fluid (CSF), or plasma testing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 96, week 216
Awards & highlights
Study Summary
This trial will test whether lecanemab is better than placebo at improving cognition and reducing brain amyloid accumulation in people with Alzheimer's disease.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Lecanemab may cause reactions similar to other monoclonal antibody treatments such as infusion-related reactions, potential allergic responses, and could possibly affect immune system functions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 55 and 80 years old and have test results showing intermediate or high brain amyloid levels.
Select...
I am between 55 and 80 years old and have test results showing intermediate or high levels of brain amyloid.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 96, week 216
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 96, week 216
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
A3 Trial: Change From Baseline in Amyloid Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) at Week 216
A45 Trial: Change From Baseline in Preclinical Alzheimer Cognitive Composite 5 (PACC5) Score at Week 216
Secondary outcome measures
A3 Trial: Change From Baseline in tau Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) at Week 216
A45 Trial: Change From Baseline in Amyloid Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) at Weeks 96 and 216
A45 Trial: Change From Baseline in Cognitive Function Index (CFI) at Week 216
+1 moreTrial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: A45 Trial: Lecanemab 5 mg/kg + 10 mg/kgExperimental 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.
Group II: A3 Trial: Lecanemab 5 mg/kg + 10 mg/kgExperimental 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.
Group III: A3 Trial: PlaceboPlacebo Group1 Intervention
Participants will receive placebo (0.9% sodium chloride solution), administered as IV infusion, every four weeks from Week 0 to 216.
Group IV: A45 Trial: PlaceboPlacebo 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lecanemab
2022
Completed Phase 1
~220
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Alzheimer's Disease, particularly those similar to Lecanemab, are anti-amyloid monoclonal antibodies. These treatments work by targeting and reducing amyloid-beta plaques in the brain, which are believed to play a key role in the progression of Alzheimer's Disease.
By binding to amyloid-beta, these antibodies facilitate its clearance from the brain, potentially slowing cognitive decline. This mechanism is crucial for Alzheimer's patients as it addresses one of the core pathological features of the disease, offering hope for improved cognitive function and quality of life.
Other treatments, such as cholinesterase inhibitors and NMDA receptor antagonists, work by enhancing neurotransmitter function to temporarily alleviate symptoms but do not modify the disease process itself.
Impact of Anti-amyloid-β Monoclonal Antibodies on the Pathology and Clinical Profile of Alzheimer's Disease: A Focus on Aducanumab and Lecanemab.Lessons Learnt from the Second Generation of Anti-Amyloid Monoclonal Antibodies Clinical Trials.
Impact of Anti-amyloid-β Monoclonal Antibodies on the Pathology and Clinical Profile of Alzheimer's Disease: A Focus on Aducanumab and Lecanemab.Lessons Learnt from the Second Generation of Anti-Amyloid Monoclonal Antibodies Clinical Trials.
Find a Location
Who is running the clinical trial?
BiogenIndustry Sponsor
639 Previous Clinical Trials
465,745 Total Patients Enrolled
Eisai Inc.Lead Sponsor
516 Previous Clinical Trials
157,633 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,693 Previous Clinical Trials
28,025,835 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have someone who knows about my daily activities and can share this information with the study team.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.My bleeding disorder is not well-controlled, with low platelets or high INR.I cannot have an MRI due to a pacemaker, metal implants, or other MRI unsafe devices.You do not have any signs of dementia according to a test called Clinical Dementia Rating (CDR).I am 55-64 with a family history of early dementia, carry the APOE4 gene, or have high brain amyloid levels.I am between 55 and 80 years old and have test results showing intermediate or high brain amyloid levels.I haven't had cancer, except for certain skin cancers or treated prostate cancer, in the last 3 years.I have had serious thoughts about or attempts at suicide in the past 6 months or have been treated for suicidal behavior in the last 5 years.I have a family history of early dementia, carry the APOE4 gene, or have high brain amyloid levels.My immune system disease is not well-controlled or needs strong medication.I am between 55 and 80 years old and have test results showing intermediate or high levels of brain amyloid.I am currently pregnant or breastfeeding.I am HIV positive.You have no signs of dementia according to a test called Clinical Dementia Rating (CDR) at the time of screening.I have had a stroke, TIA, or seizures in the last year.I am not taking any medications that are not allowed in the study.
Research Study Groups:
This trial has the following groups:- Group 1: A45 Trial: Lecanemab 5 mg/kg + 10 mg/kg
- Group 2: A3 Trial: Placebo
- Group 3: A45 Trial: Placebo
- Group 4: A3 Trial: Lecanemab 5 mg/kg + 10 mg/kg
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Alzheimer's Disease Patient Testimony for trial: Trial Name: NCT04468659 — Phase 3
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