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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 below
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I am between 55 and 80 years old and have test results showing intermediate or high brain amyloid levels.
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I am between 55 and 80 years old and have test results showing intermediate or high levels of brain amyloid.
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I am 55-64 with a family history of early dementia, carry the APOE4 gene, or have high brain amyloid levels.
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I have someone who knows about my daily activities and can share this information with the study team.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 96, week 216
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 96, week 216 for reporting.

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 more

Trial 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

Find a Location

Who is running the clinical trial?

BiogenIndustry Sponsor
639 Previous Clinical Trials
466,036 Total Patients Enrolled
Eisai Inc.Lead Sponsor
515 Previous Clinical Trials
152,685 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,660 Previous Clinical Trials
28,003,459 Total Patients Enrolled

Media Library

Lecanemab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04468659 — Phase 3
Alzheimer's Disease Research Study Groups: A3 Trial: Placebo, A45 Trial: Placebo, A3 Trial: Lecanemab 5 mg/kg + 10 mg/kg, A45 Trial: Lecanemab 5 mg/kg + 10 mg/kg
Alzheimer's Disease Clinical Trial 2023: Lecanemab Highlights & Side Effects. Trial Name: NCT04468659 — Phase 3
Lecanemab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04468659 — Phase 3
Alzheimer's Disease Patient Testimony for trial: Trial Name: NCT04468659 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research include people who are not yet 75 years old?

"This trial is only for patients aged 55 to 80. Out of the 25 trials taking place for people under 18 and 649 trials involving seniors, this is the one that meets your age specifications."

Answered by AI

Can you provide more context on Lecanemab's past medical research?

"The first lecanemab clinical trials were completed in 2012 at Facility #1. As of today, a total of 18280 have been completed with 3 more ongoing. The majority of these studies are being conducted from Lexington, Kentucky."

Answered by AI

Has the FDA approved Lecanemab for public use?

"Lecanemab has undergone Phase 3 trials, meaning that not only is there some evidence of its efficacy, but also that it has been through multiple rounds of testing for safety. Consequently, our team rates its safety as a 3."

Answered by AI

To what demographic does this research apply?

"This clinical trial is looking for 1400 individuals aged 55-80 who have Alzheimer's disease. The most notable criteria for applicants are as follows: being male or female, having a first degree relative diagnosed with dementia onset before age 75, or known to possess at least 1 apolipoprotein E4 variant (APOE4) allele. Other requirements include a Global Clinical Dementia Rating (CDR) score of 0 at screening, a Mini Mental State Examination score greater than or equal to 27 (with educational adjustments) at screening, and a Wechsler Memory Scale-Revised Logical Memory subscale II (W"

Answered by AI

How many different areas are coordinating this research?

"82 sites are running this trial at the moment, with locations in Lexington, The Villages, Cleveland and a multitude of other places. If you enroll in the study, it would be best to choose a clinic near you to limit travelling."

Answered by AI

What are the origins of this type of drug trial?

"As of right now, there are three ongoing studies for Lecanemab spanning 262 cities and 15 countries. The first study was conducted back in 2012 by Eisai Inc. 856 patients participated in the Phase 2 drug approval process. In the years since 2012, a total of 18280 trials have been completed worldwide."

Answered by AI

Are we currently accepting patients for this clinical trial?

"The study, which can be found on clinicaltrials.gov, is still recruiting patients. The listing was first put up on July 14th 2020 with the most recent update being June 14th of this year."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
California
Pennsylvania
Other
How old are they?
18 - 65
65+
What site did they apply to?
Univeristy of California, San Francisco
Boston University
University of Alabama, Birmingham
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
0

Why did patients apply to this trial?

I haven't told any body. First drug I will be taking. I’m hoping to slow the memory loss.
PatientReceived no prior treatments
Looking for clinical trials for AD. I want to eliminate or slow down dementia.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

How many screening visits. How long is trial? How long is the trial and how long do visits take?
PatientReceived 1 prior treatment
How long screening visits take? What is frequency? Should I be enrolled in the group 3 or the group 4/5?
PatientReceived no prior treatments
What days are screenings done and how long do they take?
PatientReceived no prior treatments

How responsive is this trial?

Most responsive sites:
  1. Case Western Reserve University/University Hospitals: < 48 hours
Average response time
  • < 2 Days
Typically responds via
Email
~676 spots leftby Oct 2027