LEQEMBI (Lecanemab)

Anti-amyloid monoclonal antibody for early Alzheimer's disease

Rx – Prescription Only Monoclonal Antibody
Active Ingredient
Lecanemab
Available Forms
Solution for IV infusion
Strength
100 mg/ml
Manufacturer
Eisai
Medically reviewed | Last reviewed: | Evidence level: 1A
LEQEMBI (lecanemab) is the first disease-modifying therapy approved for early Alzheimer's disease that has demonstrated a significant reduction in amyloid beta plaques and slowing of cognitive decline. It is administered as an intravenous infusion every two weeks and requires regular MRI monitoring for amyloid-related imaging abnormalities (ARIA). LEQEMBI is intended for patients with mild cognitive impairment or mild dementia due to Alzheimer's disease who carry zero or one copy of the ApoE4 gene.
📅 Published:
📅 Last reviewed:
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Written and reviewed by iMedic Medical Editorial Team | Specialists in neurology and pharmacology

Quick Facts About LEQEMBI

Active Ingredient
Lecanemab
Humanized IgG1 antibody
Drug Class
Anti-Amyloid
Monoclonal antibody
Administration
IV Infusion
Every 2 weeks
Dosage
10 mg/kg
Body weight-based
Available Forms
100 mg/ml
2 ml & 5 ml vials
Prescription Status
Rx Only
Specialist prescription

Key Takeaways About LEQEMBI

  • First disease-modifying Alzheimer's therapy: LEQEMBI targets and removes amyloid beta plaques, slowing cognitive decline by approximately 27% compared to placebo in the Clarity AD trial
  • Not a cure: LEQEMBI slows progression but does not reverse Alzheimer's disease or stop it completely
  • Regular MRI monitoring required: Brain scans are mandatory before specific doses to detect amyloid-related imaging abnormalities (ARIA)
  • Genetic testing is essential: ApoE4 status must be determined before starting treatment, as patients homozygous for ApoE4 face higher risks
  • Cannot be combined with blood thinners: Anticoagulants are contraindicated due to increased risk of serious brain bleeding

What Is LEQEMBI and What Is It Used For?

LEQEMBI (lecanemab) is a monoclonal antibody used to treat early Alzheimer's disease. It works by binding to and removing amyloid beta plaques from the brain, which are thought to damage brain cells and drive cognitive decline. LEQEMBI is the first therapy proven to both reduce amyloid plaques and slow clinical progression in Alzheimer's patients.

Alzheimer's disease is the most common form of dementia, affecting an estimated 55 million people worldwide according to the World Health Organization. The disease is characterized by a progressive loss of memory, thinking ability, and behavioral control that eventually interferes with daily activities. One of the hallmark features of Alzheimer's is the accumulation of abnormal protein clumps in the brain, known as amyloid beta plaques, which are believed to trigger a cascade of events that lead to neuronal damage and death.

LEQEMBI contains the active substance lecanemab, a humanized immunoglobulin G1 (IgG1) monoclonal antibody. Monoclonal antibodies are laboratory-made proteins designed to mimic the immune system's natural antibodies. Lecanemab specifically targets soluble amyloid beta protofibrils — early, toxic forms of amyloid aggregates that are thought to be particularly harmful to brain cells. By binding to these protofibrils with high affinity, lecanemab marks them for removal by the body's immune system, thereby reducing the overall amyloid burden in the brain.

The clinical rationale behind LEQEMBI is the amyloid hypothesis of Alzheimer's disease, which proposes that the accumulation of amyloid beta protein is a central driver of the disease process. In the landmark Clarity AD phase 3 clinical trial published in the New England Journal of Medicine in 2023, lecanemab demonstrated a statistically significant 27% reduction in cognitive and functional decline over 18 months compared to placebo. The study enrolled 1,795 patients with early Alzheimer's disease and confirmed amyloid pathology.

Who Can Take LEQEMBI?

LEQEMBI is approved for adults with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease. Before starting treatment, patients must have confirmed amyloid beta pathology, typically demonstrated through a PET scan or cerebrospinal fluid analysis. Additionally, patients must undergo genetic testing for the apolipoprotein E4 (ApoE4) gene. LEQEMBI is indicated for patients who carry zero or one copy of ApoE4 (non-carriers and heterozygous carriers). Patients who are homozygous for ApoE4 (carrying two copies) face significantly higher risks of ARIA and are generally excluded from treatment in the European indication.

The treating neurologist will perform a comprehensive evaluation, including brain MRI, cognitive testing, and genetic analysis, to determine whether a patient is a suitable candidate for LEQEMBI. It is important to note that LEQEMBI is not indicated for moderate or advanced Alzheimer's disease, as the clinical evidence applies specifically to the early stages of the condition.

How Does LEQEMBI Work?

In Alzheimer's disease, amyloid beta proteins misfold and aggregate into various forms, from small soluble oligomers and protofibrils to large insoluble plaques. These amyloid deposits interfere with communication between brain cells (neurons), trigger inflammatory responses, and ultimately lead to cell death. Symptoms develop gradually and worsen over time, progressing from mild forgetfulness to complete dependence on caregivers.

Lecanemab works by binding selectively to soluble amyloid beta protofibrils, which are considered the most neurotoxic form of amyloid aggregates. Once bound, the lecanemab-amyloid complex is recognized and cleared by the brain's immune cells (microglia) through a process called phagocytosis. This leads to measurable reductions in amyloid plaque load, as confirmed by amyloid PET imaging in clinical trials. For patients with MCI, this mechanism may delay the onset of dementia. For those with mild dementia, it may slow the progression to more severe symptoms.

Important to know:

LEQEMBI does not cure Alzheimer's disease. It slows progression but does not restore lost cognitive function. The benefits are modest in absolute terms, and treatment requires significant commitment including biweekly infusions and regular MRI monitoring. Decisions about starting LEQEMBI should involve careful discussion between the patient, their caregivers, and the treating neurologist.

What Should You Know Before Taking LEQEMBI?

Before starting LEQEMBI, patients must undergo brain MRI, ApoE4 genetic testing, and a thorough medical evaluation. LEQEMBI is contraindicated in patients with uncontrolled bleeding disorders, significant prior brain bleeding on MRI, allergy to lecanemab, or concurrent use of anticoagulants.

LEQEMBI is a powerful biological therapy that requires careful patient selection and ongoing monitoring. Understanding the contraindications, warnings, and precautions is essential for both patients and caregivers before treatment begins. The prescribing physician will conduct a series of evaluations to ensure the patient can safely receive LEQEMBI.

Contraindications

You should not receive LEQEMBI if:

  • You are allergic to lecanemab or any other ingredient in the formulation (including polysorbate 80, histidine, arginine hydrochloride)
  • You have an uncontrolled bleeding disorder
  • Your brain MRI shows significant areas of prior bleeding, fluid accumulation, or signs of major previous hemorrhage
  • You are currently taking anticoagulant medications (blood thinners such as warfarin, apixaban, rivaroxaban, edoxaban, or dabigatran)

Warnings and Precautions

Amyloid-Related Imaging Abnormalities (ARIA)

ARIA is the most significant safety concern with LEQEMBI. There are two main types:

  • ARIA-E (edema): Temporary fluid accumulation in one or more areas of the brain, visible on MRI
  • ARIA-H (hemorrhage): Small spots of bleeding in the brain or on the brain surface, also detected on MRI

Most patients who develop ARIA have no symptoms. Symptomatic ARIA occurs in approximately 2% of patients, and symptoms can include headache, confusion, dizziness, blurred vision, nausea, difficulty walking, or, rarely, seizures. In a small number of cases (less than 1%), symptoms can be severe.

Seek immediate medical attention

Contact your healthcare provider immediately if you experience sudden severe headache, confusion, vision changes, difficulty walking, or seizures during treatment with LEQEMBI. These may be signs of ARIA or intracerebral hemorrhage.

Your physician will schedule MRI scans before your 3rd, 5th, 7th, and 14th infusions as part of routine safety monitoring. Additional scans may be ordered at any time if clinically indicated. Depending on MRI findings, your physician may temporarily pause or permanently discontinue LEQEMBI treatment.

ApoE4 Genetic Risk Factors for ARIA

The apolipoprotein E4 (ApoE4) gene is a known risk factor for both Alzheimer's disease and ARIA. Patients who carry two copies of ApoE4 (homozygous carriers) have a significantly higher risk of developing ARIA, including symptomatic and severe forms. For this reason, ApoE4 genetic testing is required before starting LEQEMBI, and the European indication restricts treatment to patients with zero or one copy of the gene.

Anticoagulants and Thrombolytics

The risk of serious brain hemorrhage (intracerebral hemorrhage) is substantially increased when LEQEMBI is combined with anticoagulant medications or thrombolytic agents. LEQEMBI is contraindicated with anticoagulants. If you need a thrombolytic agent for a medical emergency (such as an acute stroke), inform the treating physicians that you are receiving LEQEMBI. Antiplatelet agents such as aspirin and other medications that prevent platelets from clumping can generally be used alongside LEQEMBI.

Infusion-Related Reactions

Infusion-related reactions are very common with LEQEMBI. Symptoms can include fever, flu-like symptoms (chills, body aches, shaking, joint pain), nausea, vomiting, changes in blood pressure, changes in heart rate, chest tightness, or breathing difficulties. If you experience an infusion-related reaction, your physician may prescribe pre-medications before future infusions, such as antihistamines, acetaminophen (paracetamol), anti-inflammatory drugs, or corticosteroids. Patients are observed for 2.5 hours after the first infusion to monitor for reactions.

Pregnancy and Breastfeeding

It is not known whether LEQEMBI can harm an unborn baby. Women of childbearing potential should use effective contraception during treatment and for at least 2 months after the last dose. A pregnancy test is performed before starting treatment. If you become pregnant while receiving LEQEMBI, inform your physician immediately. Treatment is not recommended during pregnancy.

It is unknown whether lecanemab passes into breast milk. If you are breastfeeding, discuss with your physician whether to continue breastfeeding or treatment, considering the benefits of each.

Special Populations

The safety and effectiveness of LEQEMBI have not been established in patients with autosomal dominant Alzheimer's disease, adults with Down syndrome, patients with a history of recent stroke or transient ischemic attack (TIA) within the past 12 months, patients with seizure history within the past 12 months, or immunocompromised individuals. LEQEMBI should not be used in children or adolescents under 18 years of age.

Driving and Operating Machinery

Some patients may experience dizziness or confusion while taking LEQEMBI. If you develop these symptoms, consult your physician before driving or operating machinery.

How Does LEQEMBI Interact with Other Drugs?

The most critical drug interaction with LEQEMBI involves anticoagulants (blood thinners), which are contraindicated due to the significantly increased risk of intracerebral hemorrhage. Thrombolytic agents should also be avoided. Antiplatelet medications such as aspirin may be used with caution under medical supervision.

Because LEQEMBI is a monoclonal antibody administered intravenously, it does not undergo metabolism through the liver's cytochrome P450 enzyme system, which means traditional drug-drug pharmacokinetic interactions are less of a concern compared to oral medications. However, the pharmacodynamic interaction with medications that affect blood clotting is clinically significant and potentially life-threatening.

Always inform your treating physician about all medications you are taking, have recently taken, or plan to take. This includes prescription medicines, over-the-counter drugs, herbal supplements, and vitamins.

Major Interactions

Major Drug Interactions with LEQEMBI
Drug / Class Risk Level Clinical Significance
Warfarin (Coumadin) Contraindicated Significantly increased risk of intracerebral hemorrhage. Must not be used together.
Apixaban (Eliquis) Contraindicated Direct oral anticoagulant. Increased risk of major brain bleeding when combined with LEQEMBI.
Rivaroxaban (Xarelto) Contraindicated Direct oral anticoagulant. Contraindicated due to hemorrhage risk.
Dabigatran (Pradaxa) Contraindicated Direct thrombin inhibitor. Must not be used concurrently with LEQEMBI.
Edoxaban (Lixiana) Contraindicated Direct oral anticoagulant. Contraindicated with LEQEMBI.
Thrombolytics (e.g. alteplase, tenecteplase) Contraindicated Clot-dissolving agents drastically increase bleeding risk in LEQEMBI-treated patients.
Heparin (unfractionated & LMWH) Contraindicated Anticoagulant class. Must not be used together with LEQEMBI.

Medications That May Be Used with Caution

Medications Requiring Caution with LEQEMBI
Drug / Class Risk Level Notes
Aspirin (low-dose) Use with caution Antiplatelet agent. May be used under medical supervision. Patients on aspirin were included in the Clarity AD trial.
Clopidogrel (Plavix) Use with caution Antiplatelet agent. Discuss risks and benefits with your neurologist.
Cholinesterase inhibitors (donepezil, rivastigmine, galantamine) Generally safe Standard Alzheimer's medications. No pharmacokinetic interaction expected. Can be used concurrently.
Memantine Generally safe NMDA receptor antagonist for Alzheimer's. No interaction expected with LEQEMBI.
Tell your doctor about LEQEMBI before any procedure:

If you need surgery, dental work, or any medical procedure, always inform the healthcare team that you are receiving LEQEMBI. This is especially important if the procedure involves a risk of bleeding or if anticoagulant or thrombolytic therapy may be needed.

What Is the Correct Dosage of LEQEMBI?

The recommended dose of LEQEMBI is 10 mg per kilogram of body weight, administered as an intravenous infusion every two weeks. Each infusion takes approximately one hour. The dose is calculated based on the patient's weight, and treatment is administered under medical supervision with regular MRI monitoring.

LEQEMBI is always administered by a healthcare professional in a clinical setting equipped to manage potential infusion-related reactions. The drug is supplied as a concentrate that must be diluted before infusion. Treatment begins with careful dose calculation based on the patient's body weight and is accompanied by a structured MRI monitoring schedule.

Adults

Standard Dosing

Dose: 10 mg/kg body weight

Route: Intravenous (IV) infusion

Frequency: Every 2 weeks (biweekly)

Infusion duration: Approximately 1 hour

Example: A 70 kg patient would receive 700 mg (7 ml of concentrate) diluted in 250 ml sodium chloride 0.9% solution.

More than one vial of LEQEMBI concentrate may be needed to provide the full dose. The healthcare team calculates the required volume based on the formula: total dose (mg) = patient weight (kg) × 10 mg/kg. The concentrate (100 mg/ml) is drawn from the vials and added to a 250 ml bag of 0.9% sodium chloride solution for infusion.

MRI Monitoring Schedule

Regular brain MRI scans are a mandatory component of LEQEMBI treatment to monitor for ARIA. The standard monitoring schedule includes scans before:

  • 3rd infusion (approximately week 4)
  • 5th infusion (approximately week 8)
  • 7th infusion (approximately week 12)
  • 14th infusion (approximately week 26)

Additional MRI scans may be ordered at any time if symptoms suggestive of ARIA develop or based on clinical judgment.

Children and Adolescents

LEQEMBI should not be used in children or adolescents under 18 years of age. Alzheimer's disease does not affect this age group, and no pediatric clinical data are available.

Elderly Patients

No dose adjustment is required for elderly patients. The Clarity AD trial included patients aged 50 to 90 years. However, elderly patients may be more susceptible to infusion-related reactions and ARIA, and careful monitoring is especially important in this population.

Missed Dose

If you miss a scheduled infusion of LEQEMBI, contact your healthcare provider to arrange the infusion as soon as possible. Do not wait until the next scheduled appointment. The treatment schedule should be resumed with the next dose administered two weeks after the rescheduled infusion.

Overdose

There is limited information on overdose with LEQEMBI. As an intravenous medication administered by healthcare professionals, the risk of accidental overdose is low. Treatment would be supportive and symptomatic, with close monitoring for ARIA and infusion-related reactions.

Discontinuation

Your physician may recommend pausing or stopping LEQEMBI based on MRI findings (such as significant ARIA), the development of serious side effects, or clinical considerations. The decision to restart treatment after a pause depends on the resolution of any safety concerns, as determined by follow-up MRI and clinical evaluation.

What Are the Side Effects of LEQEMBI?

The most clinically significant side effects of LEQEMBI are amyloid-related imaging abnormalities (ARIA), infusion-related reactions, and, rarely, intracerebral hemorrhage. Most side effects are manageable with appropriate monitoring and treatment, but patients must undergo regular MRI scans and report any new neurological symptoms immediately.

Like all medications, LEQEMBI can cause side effects, although not everyone will experience them. The side effect profile of LEQEMBI is well-characterized from the Clarity AD phase 3 clinical trial and post-marketing surveillance. Understanding the potential risks allows patients and caregivers to recognize warning signs early and seek appropriate medical attention.

Side Effect Frequency Overview

Very Common (affects more than 1 in 10 patients)

Reported in >10% of patients in clinical trials
  • Infusion-related reactions – fever, chills, body aches, nausea, vomiting, changes in blood pressure or heart rate, flushing, breathing difficulties

Common (affects 1 to 10 in 100 patients)

Reported in 1–10% of patients
  • Headache
  • ARIA-H – microhemorrhages or superficial siderosis (small brain bleeds detected on MRI)
  • ARIA-E – cerebral edema (fluid accumulation in the brain detected on MRI)
  • Delayed allergic reactions – rash, headache, runny nose, hair loss (appearing days after infusion)
  • Atrial fibrillation – irregular heart rhythm with symptoms such as palpitations, chest discomfort, dizziness, or fatigue
  • Nausea

Uncommon (affects 1 to 10 in 1,000 patients)

Reported in 0.1–1% of patients
  • Symptomatic ARIA – headache, confusion, dizziness, blurred vision, nausea, difficulty walking, seizures
  • Severe allergic reaction (anaphylaxis) – swelling under the skin, airway constriction, severe hypotension

Rare (affects fewer than 1 in 1,000 patients)

Reported in <0.1% of patients
  • Large intracerebral hemorrhage – major brain bleeding that can cause severe headache, confusion, seizures, or stroke-like symptoms
  • Severe symptomatic ARIA with lasting neurological consequences

ARIA in Detail

ARIA is the most closely monitored side effect of LEQEMBI and all anti-amyloid therapies. In the Clarity AD trial, ARIA-E occurred in approximately 12.6% of lecanemab-treated patients compared to 1.7% on placebo, while ARIA-H (microhemorrhages and superficial siderosis) occurred in approximately 17% of lecanemab-treated patients versus 9% on placebo. The majority of ARIA events were radiographic only (detected on MRI without any symptoms) and resolved over weeks to months.

Risk factors for ARIA include ApoE4 carrier status (particularly homozygous carriers), higher baseline amyloid levels, and the presence of pre-existing cerebral amyloid angiopathy (CAA). Patients who develop symptomatic ARIA typically present within the first 3 to 6 months of treatment, coinciding with the most active period of amyloid removal.

Infusion-Related Reactions in Detail

Infusion-related reactions were the most commonly reported adverse event in clinical trials, occurring in approximately 26% of patients receiving LEQEMBI compared to 7% on placebo. Most reactions were mild to moderate in severity and occurred during or shortly after the infusion. Reactions were most common with the first few infusions and tended to decrease in frequency over time. Symptoms include fever, chills, body aches and joint pain, nausea, vomiting, changes in blood pressure, changes in heart rate, chest discomfort, and breathing difficulties.

Pre-medication with antihistamines, paracetamol (acetaminophen), NSAIDs, or corticosteroids can reduce the incidence and severity of these reactions. Patients are monitored for at least 2.5 hours after the first infusion.

Report these symptoms immediately:

Contact your physician or seek emergency care if you experience: sudden severe headache, confusion or disorientation, vision changes, difficulty walking or loss of coordination, seizures, facial drooping, or difficulty speaking. These could indicate serious ARIA, intracerebral hemorrhage, or stroke.

How Should You Store LEQEMBI?

LEQEMBI should be stored in a refrigerator at 2–8°C, protected from light, and must not be frozen or shaken. As a hospital-administered medication, storage is managed by healthcare facilities. Once diluted for infusion, it should be used immediately or within 24 hours at room temperature.

LEQEMBI is a biological medicine that requires careful storage to maintain its effectiveness and safety. Although patients do not typically store LEQEMBI at home (as it is administered in healthcare facilities), understanding proper storage conditions is important for ensuring product quality.

  • Temperature: Store in a refrigerator at 2°C to 8°C (36°F to 46°F)
  • Light protection: Keep in the original carton to protect from light
  • Do not freeze: Freezing can damage the protein structure and render the medication ineffective
  • Do not shake: Shaking can cause protein aggregation and foaming
  • After dilution: Immediate use is recommended. If not used immediately, the diluted solution is stable for up to 24 hours at 25°C (77°F). From a microbiological standpoint, the product should be used immediately unless the dilution method excludes the risk of microbial contamination.
  • Expiry date: Do not use after the expiry date printed on the carton and vial label ("EXP"). The expiry date refers to the last day of the stated month.

Keep all medicines out of the sight and reach of children. Do not dispose of unused medication in household waste. Ask your pharmacist how to dispose of medicines you no longer use.

What Does LEQEMBI Contain?

LEQEMBI contains lecanemab 100 mg/ml as the active ingredient. The formulation includes histidine, histidine hydrochloride monohydrate, arginine hydrochloride, polysorbate 80, and water for injections. It is available in 2 ml and 5 ml single-use vials.

Active Ingredient

Each 1 ml of LEQEMBI concentrate contains 100 mg of lecanemab. Lecanemab is a humanized IgG1 monoclonal antibody produced by recombinant DNA technology in Chinese hamster ovary (CHO) cells.

Inactive Ingredients (Excipients)

  • Water for injections – solvent
  • Histidine – buffer to maintain pH stability
  • Histidine hydrochloride monohydrate – buffer component
  • Arginine hydrochloride – stabilizer to prevent protein aggregation
  • Polysorbate 80 – surfactant to prevent protein adsorption (0.5 mg per 1 ml; may cause allergic reactions in sensitive individuals)

Presentation

LEQEMBI is a clear to slightly opalescent, colorless to pale yellow concentrate for solution for infusion. Each carton contains one single-use vial:

  • 2 ml vial: Contains 200 mg of lecanemab
  • 5 ml vial: Contains 500 mg of lecanemab

The concentrate must be diluted in 250 ml of 0.9% sodium chloride solution before intravenous infusion. Compatible infusion bags include those made from polypropylene, polyvinyl chloride, co-extruded polyolefin/polyamide, or ethylene/propylene copolymer. An in-line 0.2 micrometer low-protein-binding sterile filter is recommended during infusion.

Note about sodium content:

The concentrate itself contains no sodium. However, because it must be diluted with sodium chloride solution for infusion, this should be considered for patients on a sodium-restricted diet.

Frequently Asked Questions About LEQEMBI

LEQEMBI is used to treat early Alzheimer's disease, including mild cognitive impairment (MCI) and mild dementia due to Alzheimer's. It is a monoclonal antibody that targets and removes amyloid beta plaques from the brain. The Clarity AD trial showed that LEQEMBI slowed cognitive decline by approximately 27% over 18 months compared to placebo. It is not a cure but may delay the progression from MCI to dementia or slow the worsening of mild dementia symptoms.

The most common side effects are infusion-related reactions (affecting approximately 26% of patients), which include fever, chills, nausea, body aches, and changes in blood pressure. ARIA (amyloid-related imaging abnormalities) is also common, with ARIA-E (brain edema) occurring in about 12.6% and ARIA-H (microbleeds) in about 17% of patients. Most ARIA cases are asymptomatic and detected only on MRI. Symptomatic ARIA, which can cause headache, confusion, or dizziness, occurs in approximately 2% of patients.

LEQEMBI is administered as an intravenous (IV) infusion every two weeks. The dose is 10 mg per kilogram of body weight, and each infusion takes approximately one hour. The medication must be given in a healthcare setting by trained professionals. Regular MRI scans are required throughout treatment to monitor for ARIA, particularly before the 3rd, 5th, 7th, and 14th doses.

ARIA stands for Amyloid-Related Imaging Abnormalities. ARIA-E involves temporary fluid accumulation in the brain, and ARIA-H involves small areas of bleeding. These are detected on MRI scans. Most cases cause no symptoms, but about 2% of patients develop symptoms such as headache, confusion, dizziness, or vision changes. MRI monitoring before specific doses allows physicians to detect ARIA early and decide whether to continue, pause, or stop treatment.

No, LEQEMBI is contraindicated with anticoagulants (blood thinners) such as warfarin, apixaban, rivaroxaban, and dabigatran. The combination significantly increases the risk of serious intracerebral hemorrhage (brain bleeding). Thrombolytic medications should also be avoided. However, antiplatelet agents like low-dose aspirin may be used with caution under medical supervision, as patients on antiplatelet therapy were included in the Clarity AD clinical trial.

LEQEMBI should not be used by patients who are allergic to lecanemab, those with uncontrolled bleeding disorders, patients whose brain MRI shows significant prior bleeding or fluid accumulation, or patients currently on anticoagulant therapy. Additionally, in Europe, LEQEMBI is not indicated for patients who are homozygous for ApoE4 (carry two copies of the gene) due to the significantly higher risk of ARIA. Your neurologist will perform comprehensive evaluations including brain MRI and genetic testing before starting treatment.

References

  1. van Dyck CH, Swanson CJ, Aisen P, et al. Lecanemab in Early Alzheimer's Disease. New England Journal of Medicine. 2023;388(1):9-21. doi:10.1056/NEJMoa2212948
  2. U.S. Food and Drug Administration. LEQEMBI (lecanemab-irmb) Prescribing Information. 2023. FDA Label
  3. European Medicines Agency. LEQEMBI Summary of Product Characteristics (SmPC). 2025.
  4. Alzheimer's Association. Appropriate Use Recommendations for Lecanemab. Alzheimer's & Dementia. 2023.
  5. Sims JR, Zimmer JA, Evans CD, et al. Donanemab in Early Symptomatic Alzheimer Disease: The TRAILBLAZER-ALZ 2 Randomized Clinical Trial. JAMA. 2023;330(6):512-527.
  6. World Health Organization. Dementia Fact Sheet. 2023. WHO Dementia
  7. Cummings J, Aisen P, Apostolova LG, et al. Aducanumab: Appropriate Use Recommendations. Journal of Prevention of Alzheimer's Disease. 2021;8(4):398-410.
  8. Greenberg SM, Bhatt DL, Brown RD Jr, et al. Intracerebral Hemorrhage in Patients Treated with Anti-Amyloid Antibodies. Stroke. 2024.

About Our Medical Editorial Team

This article was written and reviewed by the iMedic Medical Editorial Team, consisting of licensed physicians specializing in neurology, pharmacology, and geriatric medicine. Our team follows international guidelines from the FDA, EMA, WHO, and the Alzheimer's Association.

Medical Writing

Specialist physicians with expertise in neurology and neurodegenerative diseases

Medical Review

Independent review board following GRADE evidence framework and international drug safety standards

Evidence Level

Level 1A – Based on systematic reviews and randomized controlled trials (Clarity AD Phase 3)

Independence

No pharmaceutical funding. All content is editorially independent with no conflicts of interest.

Last fact-checked: | Next scheduled review: July 2026