6 Things You Should Know About Leqembi (Lecanemab)

By
Bre'anna Wilson
July 14, 2023
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Leqembi (Lecanemab) is the new FDA-approved medication for Alzheimer's disease. It is reported to help slow the progression of Alzheimer's disease by target beta-amyloid in the brain, one of the hallmark pathologies of the disease.


Leqembi is a very controversial drug, but here are 6 things you should know to help make an informed decision about this drug.


1. It was conducted during the COVID-19 pandemic.

Leqembi conducted their phase 3 trial from March 2019 through March 2021. Therefore, the study faced challenges including missing data, missed doses, delayed assessments, and 6-7% of their participants from both treatment and placebo groups caught COVID during the trial.


2. The primary efficacy endpoint was date from the Clinical Dementia Rating (CDR) Scale.

CDR is an outcome measure obtained through patient and caregiver interviews (which is helpful, but not always accurate or reliable) and individual scores may vary if different people administer the test due to its reliance on clinical judgment.


3. The goal of Leqembi is to alter the underlying disease course of Alzheimer's disease.

Its goal is based on the theory that beta-amyloid removal slows down the progression of the disease. Improving or stabilizing symptoms of dementia is not the focus of Leqembi. In fact, over 50% of participants were on another medication to manage symptoms of Alzheimer's disease.


4. It is only indicated for the treatment of Alzheimer's disease.

It is for those with mild cognitive impairment (MCI) or mild stages of dementia related to Alzheimer's disease. There is no safety data related to the effectiveness of initiating treatment earlier or later or for different types of dementia.


5. Adverse events related to Leqembi were common during the study.

About 45% of participants in the Leqembi treatment group experienced adverse events, compared to 22% in the placebo group. Two of the most common side effects were small hemorrhages in the brain (14%) and swelling on the brain (~13%).


6. Leqembi is administered through intravenous infusion.

A dosage of 10mg/kg is diluted in 250 mL of 0.9% normal saline. It is administered over 60 minutes, once every two weeks. An MRI is required prior to the 5th, 7th, and 14th infusions.

Please note: Bambu Care has no association with Leqembi and the information provided is for educational and informational purposes only. Talk to you or your partner’s doctor for specific advice and recommendations regarding Leqembi.

References:

DOI: 10.1056/NEJMoa2212948

https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761269s001lbl.pdf

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