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Monoclonal Antibodies

Lecanemab for Early Alzheimer's Disease

Phase 2
Waitlist Available
Research Sponsored by Eisai Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must be able to physically attend clinic visits and be willing and able to comply with all aspects of the protocol
Subjects who meet the NIA-AA core clinical criteria for probable Alzheimer's disease dementia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up extension phase: baseline, 3 months (visit 50 [extension week 13], cohort 1) or 6 months (visit 57 [extension week 27], cohort 2), 12 months and annually thereafter in the extension phase up to visit 174 [extension week 261]
Awards & highlights

Study Summary

This trial is testing a new drug, lecanemab, to see if it's effective in treating Alzheimer's disease. The trial will last 18 months and have interim analyses to update treatment allocation. Those who complete the trial or discontinue early will be eligible for the Extension Phase, which will last up to 60 months.

Who is the study for?
This trial is for individuals with early Alzheimer's disease, specifically those with mild cognitive impairment or mild dementia due to Alzheimer's. Participants should have experienced memory decline over the past year and meet certain clinical criteria. They must have a BMI between 17 and 35.Check my eligibility
What is being tested?
The study tests Lecanemab at different doses (2.5, 5, and 10 mg/kg) against a placebo in people with early Alzheimer's. It uses adaptive randomization to adjust treatment assignments based on ongoing results over an 18-month period, followed by an extension phase.See study design
What are the potential side effects?
Potential side effects of Lecanemab are not specified here but typically may include infusion-related reactions, headaches, nausea, or other drug-specific adverse events which will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can go to the clinic for visits and follow all study rules.
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I have been diagnosed with probable Alzheimer's disease.
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My memory test score is lower than normal for my age group.
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I finished or stopped the core study's treatment for specific reasons by Week 79.
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I am between 50 and 90 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~extension phase: baseline, 3 months (visit 50 [extension week 13], cohort 1) or 6 months (visit 57 [extension week 27], cohort 2), 12 months and annually thereafter in the extension phase up to visit 174 [extension week 261]
This trial's timeline: 3 weeks for screening, Varies for treatment, and extension phase: baseline, 3 months (visit 50 [extension week 13], cohort 1) or 6 months (visit 57 [extension week 27], cohort 2), 12 months and annually thereafter in the extension phase up to visit 174 [extension week 261] for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Core Study and Extension Phase: Safety will be assessed by monitoring and recording all adverse events (AEs) and serious adverse events (SAEs)
Core Study: Change from Baseline in the Alzheimer's Disease Composite Score (ADCOMS) at 12 months
Secondary outcome measures
Change From Baselines in Brain Amyloid Levels as Measured by Amyloid PET at 3 months (Visit 50 [Extension Week 13], Cohort 1) or 6 months (Visit 57 [Extension Week 27], Cohort 2), 12 months and Annually Thereafter in the Extension Phase
Core Study: Change from Baseline at 12 Months in Brain Amyloid Pathophysiology as Measured by Amyloid PET
Core Study: Change from Baseline at 18 Months in Brain Amyloid Pathophysiology as Measured by Amyloid Positron Emission Tomography (PET)
+13 more

Trial Design

7Treatment groups
Experimental Treatment
Placebo Group
Group I: Extension Phase: Lecanemab 10 mg/kgExperimental Treatment1 Intervention
All participants who fulfill Extension Phase inclusion and exclusion criteria will have the option to participate in the Extension Phase to receive lecanemab 10 mg/kg biweekly for up to 60 months or until the benefit-to-risk ratio from treatment with lecanemab is no longer considered favorable, whichever comes first. Additionally, participants who have received Extension Phase treatment for at least 18 months may opt to enter the dosing regimen substudy during which they will receive either lecanemab 10 mg/kg once every 4 weeks (Q4W) or once every 3 months (Q3M).
Group II: Core Study: Lecanemab 5.0 mg/kg monthlyExperimental Treatment1 Intervention
5.0 mg/kg monthly
Group III: Core Study: Lecanemab 5.0 mg/kg biweeklyExperimental Treatment1 Intervention
5.0 mg/kg biweekly
Group IV: Core Study: Lecanemab 2.5 mg/kg biweeklyExperimental Treatment1 Intervention
2.5 mg/kg biweekly
Group V: Core Study: Lecanemab 10 mg/kg monthlyExperimental Treatment1 Intervention
10 mg/kg monthly
Group VI: Core Study: Lecanemab 10 mg/kg biweeklyExperimental Treatment1 Intervention
10 mg/kg biweekly
Group VII: Core Study: Lecanemab-matched PlaceboPlacebo Group1 Intervention
Matching placebo biweekly

Find a Location

Who is running the clinical trial?

Eisai Inc.Lead Sponsor
515 Previous Clinical Trials
153,126 Total Patients Enrolled
BiogenIndustry Sponsor
639 Previous Clinical Trials
466,501 Total Patients Enrolled

Media Library

Alzheimer's Disease Patient Testimony for trial: Trial Name: NCT01767311 — Phase 2

Frequently Asked Questions

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

Has there been any previous research done with Lecanemab 10 mg/kg?

"Currently, three clinical studies for Lecanemab 10 mg/kg are active; two of which have reached Phase 3. Most trials for this medication take place in Boston, but there are 545 other locations running experiments with the same drug dosage."

Answered by AI

Does this investigation mark a pioneering step in its field?

"Lecanemab 10 mg/kg has had a long history of investigation, beginning in 2012 with an 856-person clinical trial sponsored by Eisai Inc.. The drug was subsequently approved for Phase 2 use and is currently being tested in 3 trials taking place across 263 cities and 15 countries."

Answered by AI

Does the FDA recognize Lecanemab 10 mg/kg for therapeutic use?

"There is limited clinical data demonstrating the safety of Lecanemab 10 mg/kg, so it received a rating of 2. To date, there have been no studies that examine its efficacy."

Answered by AI

Is the enrollment period for this clinical experiment still open?

"Unfortunately, no more participants are needed for this study, which began on December 20th 2012 and was most recently updated June 13 2022. For those searching for other medical studies related to Alzheimer's disease, 546 trials are still recruiting patients. Additionally, 3 clinical trials with Lecanemab 10 mg/kg as the primary intervention remain open to new enrollees."

Answered by AI

Is the age limitation of this trial eighty-five years or under?

"This research initiative is open to enrolment from individuals over the age of 50 and below 90 years old."

Answered by AI

How many healthcare facilities are currently hosting this investigation within the state?

"100 different medical centres are hosting this study, with major facilities in Chicago, Elk Grove Village and Columbus. It is recommended to select the closest centre possible in order to reduce travel time should you decide to join the trial."

Answered by AI

How many participants is this research endeavor accommodating?

"This clinical trial closed its doors for participant recruitment on June 13th, 2022. If you're looking for other studies to join, there are currently 546 trials that accept participants with Alzheimer's disease and 3 research projects recruiting those interested in Lecanemab 10 mg/kg."

Answered by AI

Who meets the criteria to join this scientific experiment?

"This trial is enrolling 856 individuals aged between 50 and 90 with Alzheimer's disease. To meet the criteria for participation, they must have a Clinical Dementia Rating (CDR) score of 0.5-1.0 as well as Memory Box score greater than or equal to 0.5 at Screening and Baseline; additionally subjects should demonstrate a history of gradual subjective memory decline over the last year before testing that can be corroborated by an informant, meeting NIA-AA core clinical criteria for probable Alzheimer's disease dementia, and having scores no more than 15/12/11/9 respectively if aged between 50–"

Answered by AI

Who else is applying?

What state do they live in?
Illinois
Georgia
New York
Other
How old are they?
18 - 65
What site did they apply to?
Facility #2
Facility #1
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?

looking for lecunimab trial. My Mother died of Alzheimer’s disease. I've not been involved in any studies.
PatientReceived 2+ prior treatments
on 1 medication hoping to delay systems. I’ve never been in a trial. I’m currently on Aricept.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

Whats involved in screening? Where is the study taking place? How long does it take to find out eligibility ?
PatientReceived 2+ prior treatments
Recent research and studies
Alzheimer's Research & TherapyJournal
A Randomized, Double-blind, Phase 2b Proof-of-concept Clinical Trial in Early Alzheimer’s Disease with Lecanemab, an Anti-aβ Protofibril Antibody
Swanson, Chad J., Yong Zhang, Shobha Dhadda, Jinping Wang, June Kaplow, Robert Y. K. Lai, Lars Lannfelt, et al.. 2021. “A Randomized, Double-blind, Phase 2b Proof-of-concept Clinical Trial in Early Alzheimer’s Disease with Lecanemab, an Anti-aβ Protofibril Antibody”. Alzheimer's Research & Therapy. Springer Science and Business Media LLC. doi:10.1186/s13195-021-00813-8.
Alzheimer's Research & TherapyJournal
A Randomized, Double-blind, Phase 2b Proof-of-concept Clinical Trial in Early Alzheimer’s Disease with Lecanemab, an Anti-aβ Protofibril Antibody
Swanson, Chad J., Yong Zhang, Shobha Dhadda, Jinping Wang, June Kaplow, Robert Y. K. Lai, Lars Lannfelt, et al.. 2021. “A Randomized, Double-blind, Phase 2b Proof-of-concept Clinical Trial in Early Alzheimer’s Disease with Lecanemab, an Anti-aβ Protofibril Antibody”. Alzheimer's Research & Therapy. Springer Science and Business Media LLC. doi:10.1186/s13195-021-00813-8.
clinicaltrials.govStudy
A Study to Evaluate Safety, Tolerability, and Efficacy of Lecanemab in Subjects With Early Alzheimer's Disease
2012. "A Study to Evaluate Safety, Tolerability, and Efficacy of Lecanemab in Subjects With Early Alzheimer's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01767311.
~53 spots leftby Feb 2025
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