Apply to Trial

Compensation: Varies

Number of Visits: Unknown

Duration: 216 weeks

1400 Participants Needed

Lecanemab for Alzheimer's Disease

Recruiting at 47 trial locations

Overseen ByACTC Recruitment Unit

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Eisai Inc.

Must not be taking: Anti-amyloid immunotherapy, Immunoglobulins

Disqualifiers: Pregnancy, Stroke, Seizures, Psychiatric diagnosis, others

Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval

Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that taking certain prohibited medications may exclude you from participating. It's best to discuss your current medications with the trial team to see if they are allowed.

What data supports the effectiveness of the drug Lecanemab for Alzheimer's disease?

Research shows that Lecanemab helps clear amyloid-β (a protein linked to Alzheimer's) from the brain and slows down memory and thinking problems in people with early Alzheimer's disease.¹ ² ³ ⁴ ⁵

Is Lecanemab safe for humans?

Lecanemab has been studied for safety in people with Alzheimer's disease, and while it has shown some effectiveness in reducing brain amyloid-β, the safety data is primarily available for this condition. It is important to discuss with a healthcare provider to understand the potential risks and benefits for your specific situation.¹ ² ³ ⁴ ⁵

What makes the drug lecanemab unique for treating Alzheimer's disease?

Lecanemab is unique because it is a humanized antibody that targets and clears amyloid-β, a protein linked to Alzheimer's, and is specifically approved for early stages of the disease. It has shown to reduce brain amyloid-β and slow cognitive decline in patients with mild cognitive impairment or mild dementia.¹ ² ³ ⁴ ⁵

What is the purpose of this trial?

This trial is testing lecanemab, a drug aimed at improving memory and thinking skills in people with early signs of Alzheimer's disease. The drug works by reducing amyloid plaques in the brain, which are believed to contribute to Alzheimer's. Researchers want to see if lecanemab is effective over several years.

Eligibility Criteria

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.

Inclusion Criteria

A45 Trial: Elevated brain amyloid pathology by amyloid PET: defined as approximately greater than (>) 40 Centiloids on screening scan A3 Trial: Intermediate levels of brain amyloid pathology by amyloid PET: defined as approximately 20 to 40 Centiloids on screening scan

I have someone who knows about my daily activities and can share this information with the study team.

Mini Mental State Examination score greater than or equal to (>=) 27 (with educational adjustments) at screening.

See 12 more

Exclusion Criteria

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.

Known or suspected history of drug or alcohol abuse or dependence within 2 years before screening or a positive urine drug test at screening. Participants who test positive for benzodiazepines, opioids, or tetrahydrocannabinol (THC) in urine drug testing need not be excluded unless in the clinical opinion of the investigator this is due to potential drug abuse

See 13 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive lecanemab or placebo as IV infusion every two to four weeks for 216 weeks

216 weeks

Every two to four weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Extension

Participants may continue to receive lecanemab in an extension phase for up to 312 weeks

96 weeks

Treatment Details

Interventions

Lecanemab
Placebo

Trial Overview 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.

Participant Groups

6Treatment groups

Experimental Treatment

Placebo Group

Group I: A45 Trial: Lecanemab 5 mg/kg + 10 mg/kg (Core Study)Experimental 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 in core study.

Group II: A45 Trial: Lecanemab 10 mg/kg (Extension Phase)Experimental Treatment1 Intervention

Participants progressing to early Alzheimer's disease (EAD) during the core study (progressors) will receive lecanemab 10 mg/kg, administered as IV infusion, every two weeks after transition to the extension phase through to at least Week 216 from randomization in the core study. Participants completing the core study (completers) will enter extension phase and will receive lecanemab 10 mg/kg, administered as IV infusion, every two weeks for up to Week 312. Eligible participants receiving placebo in core study will continue to extension phase.

Group III: A3 Trial: Lecanemab 5 mg/kg + 10 mg/kg (Core Study)Experimental 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 in core study.

Group IV: A3 Trial: Lecanemab 10 mg/kg (Extension Phase)Experimental Treatment1 Intervention

Participants progressing to EAD during the core study (progressors) will receive lecanemab 10 mg/kg, administered as IV infusion, every two weeks after transition to the extension phase through to at least Week 216 from randomization in the core study. Participants completing the core study (completers) will enter extension phase and will receive lecanemab 10 mg/kg, administered as IV infusion, every two weeks for up to Week 312. Eligible participants receiving placebo in core study will continue to extension phase.

Group V: A45 Trial: Placebo (Core Study)Placebo 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.

Group VI: A3 Trial: Placebo (Core Study)Placebo Group1 Intervention

Participants will receive placebo (0.9% sodium chloride solution), administered as IV infusion, every four weeks from Week 0 to 216.

Lecanemab is already approved in United States, Japan for the following indications:

Approved in United States as Leqembi for:

Early symptomatic Alzheimer's disease

Approved in Japan as Leqembi for:

Early symptomatic Alzheimer's disease

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eisai Inc.

Lead Sponsor

Trials

524

Recruited

161,000+

Founded

Eisai Inc. was established in 1995 as the U.S. subsidiary of Eisai Co., Ltd.

Headquarters

Woodcliff Lake, NJ, USA

Known For

Neurology and Oncology

Findings from Research

In an 18-month double-blind randomized placebo-controlled trial, lecanemab was effective in clearing amyloid-β in two-thirds of participants with mild cognitive impairment and mild dementia due to Alzheimer's disease.

Lecanemab also significantly reduced the rate of cognitive and functional decline in these individuals, suggesting its potential as a therapeutic intervention for early Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lecanemab reduces brain amyloid-β and delays cognitive worsening.Knopman, DS.[2023]

Lecanemab, a humanized monoclonal antibody, significantly reduces brain amyloid levels and leads to moderate improvements in cognitive function in Alzheimer's patients, as shown in the Clarity AD phase III trial with 18 months of treatment.

While lecanemab demonstrates efficacy in slowing cognitive decline, it is associated with adverse events such as infusion-related reactions (26.4%) and amyloid-related imaging abnormalities (12.6%), raising concerns about its administration and monitoring requirements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lecanemab: A Humanized Monoclonal Antibody for the Treatment of Early Alzheimer Disease.Park, J., Simpson, C., Patel, K.[2023]

Lecanemab has shown promise in treating early Alzheimer's disease, demonstrating a significant reduction in clinical decline among participants in the study.

The study involved a large cohort, providing robust evidence for lecanemab's efficacy, although specific details on the number of subjects and duration were not provided in the overview.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence for lecanemab in early Alzheimer's disease.[2023]