What side effects are associated with this type of intervention?

Common treatments for Alzheimer's Disease, particularly anti-amyloid monoclonal antibodies like Lecanemab and Bapineuzumab, have been associated with several side effects. Bapineuzumab has been linked to serious adverse events, which has led to recommendations against its use in mild to moderate Alzheimer's Disease. Lecanemab, currently under study, aims to reduce brain amyloid accumulation and improve cognitive function, but specific side effects from the study are not detailed in the provided context. Generally, treatments targeting amyloid β proteins may involve risks such as brain swelling (amyloid-related imaging abnormalities), headaches, and infusion-related reactions.

What other types of research exist?

Promising novel alternatives to Lecanemab for Alzheimer's Disease patients in 2024 include: 1) Donanemab, another anti-amyloid monoclonal antibody showing potential in clinical trials. 2) Aducanumab, which targets amyloid plaques and has received conditional approval. 3) Tau-targeting therapies like semorinemab and tilavonemab, which aim to prevent tau protein aggregation. 4) Anti-inflammatory agents such as ALZT-OP1, which target neuroinflammation. 5) Synaptic health enhancers like BPN14770, which aim to improve cognitive function by enhancing synaptic resilience.

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Monoclonal Antibodies

Lecanemab for Alzheimer's Disease

Q: What prior FDA approvals exist?

Lecanemab is an anti-amyloid monoclonal antibody being studied for the treatment of Alzheimer's Disease. Similar FDA-approved treatments include aducanumab (Aduhelm), which was approved in June 2021. Aducanumab works by targeting amyloid-beta plaques in the brain, which are believed to play a role in Alzheimer's pathology. Another drug in this class is donanemab, which is currently under review by the FDA. These treatments aim to slow the progression of Alzheimer's by reducing amyloid plaque accumulation in the brain.

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, 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

Must not have

Females who are breastfeeding or pregnant at screening or baseline

Contraindications to 3 Tesla magnetic resonance imaging (MRI) scanning, including cardiac pacemaker/defibrillator, ferromagnetic metal implants (example, in-skull and cardiac devices other than those approved as safe for use in MRI scanners), or exhibit other significant pathological findings on brain MRI at Screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 216

Awards & highlights

Pivotal Trial

Summary

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.

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.

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.

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.

Exclusion Criteria

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

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I am currently pregnant or breastfeeding.

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I cannot have an MRI due to a pacemaker, metal implants, or other MRI unsafe devices.

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My immune system disease is not well-controlled or needs strong medication.

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My bleeding disorder is not well-controlled, with low platelets or high INR.

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I am HIV positive.

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I have had serious thoughts about or attempts at suicide in the past 6 months or have been treated for suicidal behavior in the last 5 years.

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I am not taking any medications that are not allowed in the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 216

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 216

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 216 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

A45 Trial: Change From Baseline in Preclinical Alzheimer Cognitive Composite 5 (PACC5) Score at Week 216

Secondary study objectives

A45 Trial: Change From Baseline in Cognitive Function Index (CFI) at Week 216

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lecanemab

2020

Completed Phase 3

~3530

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Alzheimer's Disease, particularly those similar to Lecanemab, are anti-amyloid monoclonal antibodies. These treatments work by targeting and reducing amyloid-beta plaques in the brain, which are believed to play a key role in the progression of Alzheimer's Disease. By binding to amyloid-beta, these antibodies facilitate its clearance from the brain, potentially slowing cognitive decline. This mechanism is crucial for Alzheimer's patients as it addresses one of the core pathological features of the disease, offering hope for improved cognitive function and quality of life. Other treatments, such as cholinesterase inhibitors and NMDA receptor antagonists, work by enhancing neurotransmitter function to temporarily alleviate symptoms but do not modify the disease process itself.

Impact of Anti-amyloid-β Monoclonal Antibodies on the Pathology and Clinical Profile of Alzheimer's Disease: A Focus on Aducanumab and Lecanemab.Lessons Learnt from the Second Generation of Anti-Amyloid Monoclonal Antibodies Clinical Trials.