Present estimates show that 6.5 million US individuals are living with Alzheimer's disease, and calculations propose the number can triple in just a few decades. The huge, anticipated increase is associated with an aging population, lifestyle risk factors, and chronic disease. Cases among younger individuals may also be increasing. With these considerations and the knowledge that, historically, studies have not had full information regarding incidence in all countries, the actual number of global instances may even be much higher than the present estimate of 50 million. New treatments to help slow the life-threatening disease's effects are in critical demand.
Earlier detectable symptoms of Alzheimer's disease include mild cognitive impairment. Thoughts, memories, and language skills are affected, and the patient's quality of life degrades. The condition becomes dangerous when progression occurs and physical functionality is impacted. Immobility with resulting infections and issues with swallowing and aspiration are the usual circumstances that lead to death.
There is no cure for Alzheimer's disease. Most of the common treatments work to regulate neurotransmitters, which aids in some cases of memory loss and behavioral issues. For mild-to-moderate disease,
donepezil,
rivastigmine, and
galantamine are used to combat symptoms. Individuals with moderate-to-severe disease are commonly prescribed
donepezil,
memantine, the
rivastigmine patch, or a
donepezil/memantine combination. While these drugs are helpful for many patients, the development of and access to effective and safe therapy that goes beyond symptomatic treatment and instead delays or slows the degradation and death of brain cells is a desirable goal.
The recent approval of
Leqembi (lecanemab) marks a significant milestone in reaching that goal. Fast-tracked for approval in January of this year and then granted full approval by the FDA in July 2023, lecanemab is now the first immunotherapy with this clearance. Prior to this, the disease-modifying therapy
Aduhelm (aducanumab) was granted accelerated approval by the FDA in June 2021. However, without full approval and debated effectiveness, coverage for and use of the drug has remained limited.
Lecanemab targets the amyloid-beta protein as it begins to form fibers that accumulate as plaques in the brain. Accumulation of the abnormal structures results in adverse effects on brain function. By mimicking the response of human antibodies to clear the protein from brain tissues, monoclonal antibodies like lecanemab work to modify the pathophysiology of Alzheimer's disease. It is not a cure for the disease, but it is able to slow down the memory and thinking decline in patients during the early stages.
The government has established labeling, prescribing, and coverage parameters for lecanemab due to concerns connected to rare but serious adverse effects, specifically amyloid-related imaging abnormalities (ARIA). The drug's prescribing information includes a boxed warning to alert providers, patients, and caregivers about the potential risks associated with ARIA. The prescribing information also stipulates that before beginning treatment with lecanemab, patients must complete diagnostic testing to confirm the presence of amyloid-beta proteins. Additional genetic testing is also recommended for identifying what version of the ApoE gene a patient carries. Research has indicated that individuals who carry ApoE e4 have a higher risk of serious side effects with lecanemab. For Medicare patients to receive coverage, those prescribed lecanemab must be enrolled in a qualifying registry, such as the
CMS-facilitated registry now open for clinicians to access.
To make a significant difference for patients with Alzheimer's disease, access to approved therapies needs to increase. Accomplishing this while protecting patient safety is necessary. As the clinical practice for treating Alzheimer's disease continues to evolve, stay informed about critical drug information, including targeted therapies for Alzheimer's disease, by exploring
PDR by ConnectiveRx. You can also stay current by using the official PDR app,
mobilePDR, available for free from your preferred app store.
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