Leqembi® (Lecanemab-irmb)

FDA-Approved IV Therapy for Early Alzheimer's Disease

What is Leqembi?

LEQEMBI (lecanemab-irmb) is an FDA-approved intravenous monoclonal antibody for early Alzheimer disease—mild cognitive impairment (MCI) due to AD or mild AD dementia. It targets amyloid-beta protofibrils to reduce brain amyloid and modestly slow cognitive and functional decline. Leqembi is not a cure; it is designed to slow disease progression in appropriately selected patients.

Treatment requires careful patient selection, MRI monitoring for ARIA, and infusion-center infrastructure. For patients in Beachwood, Cleveland, and Northeast Ohio, coordination with local neurologists and confirmation of amyloid positivity and insurance/prior authorization is essential before referral.

Boxed Warning: ARIA (Amyloid-Related Imaging Abnormalities)

LEQEMBI can cause ARIA-E (edema) and ARIA-H (microhemorrhage/hemosiderin). These can be asymptomatic or cause headache, confusion, visual changes, dizziness, or focal neurologic deficits; rarely, serious or fatal hemorrhage has occurred. MRI monitoring before and during treatment is required. Do not initiate in patients with pre-existing hemorrhage risk that outweighs benefit. Discuss risks with your neurologist.

Key Clinical Evidence (CLARITY AD)

The pivotal CLARITY AD Phase 3 trial established Leqembi's efficacy and supported traditional FDA approval (July 2023).

27% slowing of cognitive and functional decline vs. placebo at 18 months (CDR-SB)

CLARITY AD Trial Summary

  • Participants: 1,795 patients with early AD (MCI or mild dementia), amyloid-positive by PET or CSF
  • Primary endpoint: Change in Clinical Dementia Rating–Sum of Boxes (CDR-SB) at 18 months
  • Result: Statistically significant slowing of decline; benefit was evident by 6 months and sustained
  • Secondary: Benefits on cognition (ADAS-Cog14) and daily function (ADCS-MCI-ADL); amyloid PET showed substantial plaque reduction

The clinical effect is modest—frame expectations as slowing progression rather than reversing disease.

How Leqembi Works

Leqembi is a humanized IgG1 monoclonal antibody that binds soluble and insoluble amyloid-beta, including protofibrils—toxic aggregates thought to drive neuronal damage. By clearing these, Leqembi reduces amyloid plaque burden and is associated with slower cognitive and functional decline in early AD.

Dosing and Administration

IV Dosing (Current Label)

  • Initiation (first 18 months): 10 mg/kg IV every 2 weeks, over approximately 1 hour
  • Maintenance (after 18 months): 10 mg/kg IV every 4 weeks or transition to subcutaneous LEQEMBI IQLIK (360 mg weekly) when approved and appropriate
  • Dose is weight-based; dilute in 0.9% sodium chloride; use 0.2-micron in-line filter
  • Premedication may be used for infusion-related reactions (e.g., antihistamines, NSAIDs, corticosteroids)

Safety, ARIA, and Monitoring

MRI Monitoring Required

Obtain baseline brain MRI before starting. Repeat at specified intervals (e.g., before infusions 3, 5, 7, and 14 per label and AUR guidance) to detect ARIA. Monitor for new neurologic symptoms; if ARIA is suspected, hold dosing and obtain urgent MRI. Management may include dose interruption and, in severe or symptomatic cases, permanent discontinuation.

APOE ε4 carrier status increases ARIA risk; testing is recommended to inform shared decision-making.

Common adverse reactions include infusion-related reactions (e.g., fever, chills, rash, blood pressure changes), headache, and ARIA. Infusion-related reactions occurred in about 26% of patients in CLARITY AD; most were mild to moderate.

Who May Be a Candidate?

Appropriate Candidates

  • Adults with early Alzheimer's (MCI due to AD or mild dementia due to AD)
  • Confirmed amyloid pathology (positive amyloid PET or CSF biomarkers)
  • Ability to comply with regular infusions, MRI monitoring, and safety follow-up

Leqembi may NOT be appropriate for:

  • Moderate or severe dementia (efficacy/safety not established)
  • Extensive microhemorrhages, prior lobar hemorrhage, or other MRI findings that increase hemorrhage risk
  • Patients unable to undergo required MRI monitoring

Decisions should be made with a neurologist or memory specialist, patient, and caregivers.

Quick Reference

AttributeLeqembi (lecanemab-irmb)
IndicationEarly AD (MCI or mild dementia due to AD)
MechanismAnti–amyloid β protofibril monoclonal antibody
DosingIV 10 mg/kg every 2 weeks (initiation); monthly IV or weekly SC maintenance after 18 months
Major riskARIA (E and H); MRI monitoring required

Leqembi at CarePoint Infusion Center

At CarePoint Infusion Center, Leqembi infusions are administered in a comfortable, outpatient setting under the supervision of experienced infusion nurses. We coordinate with referring neurologists and memory specialists to ensure:

  • Pre-infusion: Amyloid confirmation, baseline MRI, consent, and eligibility review
  • During infusion: ~1-hour IV infusion with continuous monitoring; observation post-infusion
  • Safety: Recognition of infusion-related reactions and ARIA symptoms; communication with prescriber for MRI scheduling and dose holds when needed
  • Access: Assistance with prior authorization, insurance verification, and manufacturer support programs (e.g., LEQEMBI Companion Program) where applicable

We serve patients from Beachwood, Cleveland, and throughout Northeast Ohio. Patients and families should contact a local neurologist or memory specialist for eligibility evaluation and confirm insurance coverage before scheduling infusion.

Serving Northeast Ohio Communities

CarePoint Infusion Center provides Leqembi and other infusion therapies to patients across Beachwood, Cleveland, Cuyahoga County, and Northeast Ohio.

We conveniently serve patients from:

And throughout Cuyahoga County and Northeast Ohio. Contact us to discuss infusion scheduling and coordination with your neurologist.


Next Steps

If you or a loved one is considering Leqembi for early Alzheimer's disease:

  • Speak with a neurologist or memory specialist for diagnosis, amyloid confirmation, and eligibility
  • Confirm insurance coverage and prior authorization requirements (Medicare covers Leqembi for eligible patients when physicians participate in a qualifying registry)
  • Contact CarePoint for infusion scheduling once referred by your provider

Contact CarePoint Infusion Center:

  • Phone: 216-755-4044
  • Address: 23215 Commerce Park Suite 318, Beachwood, OH 44122

Visit our Contact page to send a message or request a call.


Additional Resources


Disclaimer

This information is for educational purposes only and does not constitute medical advice. Treatment decisions must be made by qualified healthcare professionals in consultation with the patient. Eligibility for Leqembi, MRI monitoring, and dosing are determined by the prescribing physician. Always consult your neurologist or memory specialist for diagnosis and treatment.