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Update on the Alzheimer Disease clinical trial of lecanemab

Dementia specialists at Mass General Brigham (MGB) are aware of the recent news release from the Clarity Alzheimer Disease clinical trial of lecanemab, a medication that works by removing abnormal amyloid from the brain. Summarized outcomes of the study involving participants experiencing the early stage of Alzheimer Disease included a reduction of rate of clinical decline compared to placebo over 18 months as well as diminished brain amyloid levels. Reportedly, the incidence of adverse events was 21% for those who received lecanemab and 9% for those who received a placebo. About 25% of the U.S. participants in this study were Hispanic and African American. More detailed information about the study's results will be reported at the Clinical Trials on Alzheimer's Disease conference in late November. We eagerly await publication of the data in a peer-reviewed scientific journal.

The manufacturer of lecanemab, has already applied to the US Food and Drug Administration (FDA) for approval of this medication. A preliminary decision is expected to be reached in January 2023. However, a final decision by the FDA is likely to take much longer. If lecanemab receives FDA approval, the Centers for Medicare & Medicaid Services (CMS) as well as other health insurance companies will decide on whether and under what circumstances lecanemab may be covered. The National Institute of Aging is currently funding two studies to evaluate lecanemab's effectiveness at treating different types of Alzheimer disease, with one of the trials testing whether this medication can slow or prevent the onset of symptoms.

MGB dementia specialists will be closely monitoring the status of lecanemab. If approved by the FDA, lecanemab will be subject to review by the MGB Pharmacy and Therapeutics Committee that is charged with evaluating and providing recommendations for the use of medications at our Institution. The evaluation will include a review of clinical, economic, and operational considerations. In the meantime, systems are being readied to help ensure safe treatment with lecanemab within the MGB system, should it receive approval.

How will the most up-to-date information be communicated to patients and their families?

We take patient care and the battle against Alzheimer's very seriously here at MGB. We understand that many patients are eager to receive new kinds of treatment as soon as possible. We will provide updates regarding lecanemab and its availability via this website and Patient Gateway.

If I have further questions, should I speak with my doctor?

You are always welcome to speak with your MGB doctor to discuss any questions or concerns you may have. You may connect with your doctor via Patient Gateway or calling our clinic phone number (617-732-8060).

If I am enrolled in a clinical trial, should I continue?

We would encourage you to continue participation in ongoing clinical trials at this time. If you have any questions, please discuss them with your doctor.

I am not currently a patient of the Alzheimer Center or related neurology or geriatric psychiatry clinics at MGB. How can I be evaluated at your center?

The phone number to initiate becoming a patient through our Neurology Patient Access Center at the Brigham is 617-732-8060. Your current doctor will be asked to send a referral. The coordinators in our center will help you schedule an appointment with the most appropriate doctor for your care and assist you through the process of becoming a new patient.

We understand you may have additional questions about the potential of this drug. We will continue to keep you updated as soon as information becomes available, and we thank you for your patience.

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