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Monoclonal Antibodies

Lecanemab for Early Alzheimer's Disease (Clarity AD Trial)

Phase 3
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
Male or female participants aged >=50 and <=90 years at the time of informed consent
Positive biomarker for brain amyloid pathology
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose of study drug up to approximately 51 months (including 3 months follow up) for the extension phase
Awards & highlights

Clarity AD Trial Summary

This trial will study lecanemab, a potential new Alzheimer's disease treatment, to see if it is better than placebo at improving symptoms and slowing disease progression. The long-term safety and effects of lecanemab will also be studied.

Who is the study for?
This trial is for men and women aged 50-90 with early Alzheimer's, who have memory decline over the last year, a BMI of >17 and <35, and are on stable medication or treatment-naive. They need a partner to support them throughout the study. Exclusions include other psychiatric or unstable conditions, recent participation in certain AD studies, MRI contraindications, uncontrolled bleeding disorders, or significant neurological issues beyond Alzheimer's.Check my eligibility
What is being tested?
The trial tests Lecanemab against a placebo in people with early Alzheimer's Disease (EAD). It measures changes from baseline in dementia severity at 18 months using CDR-SB scores. The long-term safety of Lecanemab will also be assessed during an Extension Phase to see if initial benefits hold over time.See study design
What are the potential side effects?
While specific side effects for Lecanemab aren't listed here, common ones for similar treatments may include infusion reactions like redness or pain at injection site, headaches, nausea, fatigue and potential allergic responses.

Clarity AD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 50 and 90 years old.
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My tests show positive for brain amyloid.
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My mental state score is between 22 and 30.
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I have been diagnosed with Mild Cognitive Impairment likely due to Alzheimer's.
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I have been diagnosed with probable Alzheimer's disease.

Clarity AD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose of study drug up to approximately 51 months (including 3 months follow up) for the extension phase
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of study drug up to approximately 51 months (including 3 months follow up) for the extension phase for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complementarity Determining Regions
Extension Phase: Change from Core Study Baseline in CDR-SB
Therapeutic procedure
Secondary outcome measures
Core Phase: Change From Baseline in Alzheimer's Disease Composite Score (ADCOMS) at 18 Months
Positron-Emission Tomography
Core Study: Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS MCI-ADL) at 18 Months
+1 more

Clarity AD Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Extension Phase: Lecanemab 720 mg Subcutaneous Injection WeeklyExperimental Treatment1 Intervention
This will include approximately 40 de novo participants (those that did not participate in the core study) with early Alzheimer disease (AD).
Group II: Extension Phase: Lecanemab 10 mg/kg biweeklyExperimental Treatment1 Intervention
Group III: Core Study: Lecanemab 10 mg/kg biweeklyExperimental Treatment1 Intervention
Group IV: Core Study: PlaceboPlacebo Group1 Intervention
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?

Eisai Inc.Lead Sponsor
515 Previous Clinical Trials
157,065 Total Patients Enrolled
BiogenIndustry Sponsor
639 Previous Clinical Trials
465,416 Total Patients Enrolled

Media Library

Lecanemab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03887455 — Phase 3
Alzheimer's Disease Research Study Groups: Extension Phase: Lecanemab 10 mg/kg biweekly, Extension Phase: Lecanemab 720 mg Subcutaneous Injection Weekly, Core Study: Lecanemab 10 mg/kg biweekly, Core Study: Placebo
Alzheimer's Disease Clinical Trial 2023: Lecanemab Highlights & Side Effects. Trial Name: NCT03887455 — Phase 3
Lecanemab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03887455 — Phase 3

Frequently Asked Questions

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

Is this clinical trial only accepting patients that are over 25 years old?

"This particular study is only enrolling patients between the ages of 50 and 90. However, there are 23 other clinical trials that younger individuals can participate in and 556 different trials for seniors."

Answered by AI

Can you tell me what other research studies have been done that include Lecanemab?

"There are 3 clinical studies that have been initiated for Lecanemab. Out of these, 2 are in Phase 3. The global trial is being conducted in 540 medical facilities, with the majority of centres located in Santander, Florida."

Answered by AI

Are there any life-threatening risks associated with Lecanemab?

"Lecanemab's safety is estimated to be a 3. This is due to the fact that Lecanemab is in Phase 3 trials, meaning that there are both some data supporting efficacy and multiple rounds of data supporting safety."

Answered by AI

Does this research have any predecessors?

"Eisai Inc. ran the first clinical trial for Lecanemab in 2012 and since then, 3 more trials have been completed across 262 cities and 15 countries. A total of 18291 studies have been completed to date."

Answered by AI

To what type of patient does this study pertain?

"This study is seeking 1906 participants that are currently suffering from Alzheimer's disease. The patients must be between the ages of 50 and 90. In addition, the following criteria must be met: Have a global Clinical Dementia Rating (CDR) score of 0.5 and CDR Memory Box score of 0.5 or greater at Screening and Baseline, Meet the National Institute of Aging - Alzheimer's Association (NIA-AA) core clinical criteria for MCI due to Alzheimer's disease - intermediate likelihood, Report a history of subjective memory decline with gradual onset and slow progression over the last 1 year before Screening;"

Answered by AI

Are individuals currently being accepted into this research project?

"The clinicaltrials.gov website suggests that this study is not looking for any more patients at the moment. Although, it's worth noting that there are 565 other studies which are recruiting individuals."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

Recent research and studies
clinicaltrials.govStudy
A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease
2019. "A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03887455.
~755 spots leftby Sep 2027
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