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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

Must not have

Contraindications to MRI scanning, including cardiac pacemaker/ defibrillator, ferromagnetic metal implants, e,g., in skull and cardiac devices other than those approved as safe for use in MR scanners

Evidence of other clinically significant lesions that could indicate a dementia diagnosis other than AD on brain MRI at Screening, or other significant pathological findings on brain MRI at Screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the time the participant signs the informed consent form until 3 months after the last dose of study drug or through the last visit, whichever is longer; up to 78 months

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot have an MRI due to a pacemaker or certain metal implants.

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My brain MRI does not show signs of dementia other than Alzheimer's.

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I do not have mental health issues that could affect my participation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the time the participant signs the informed consent form until 3 months after the last dose of study drug or through the last visit, whichever is longer; up to 78 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the time the participant signs the informed consent form until 3 months after the last dose of study drug or through the last visit, whichever is longer; up to 78 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the time the participant signs the informed consent form until 3 months after the last dose of study drug or through the last visit, whichever is longer; up to 78 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Core Study and Extension Phase: Safety will be assessed by monitoring and recording all adverse events (AEs) and serious adverse events (SAEs)

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