On Thursday, July 6, the Food and Drug Administration (FDA) gave full approval to Leqembi, whose generic name is lecanemab, the first drug that shows hope in changing the course of Alzheimer’s disease.
Alzheimer’s disease affects more than 6 million Americans. Scientists have been searching for an effective treatment for decades and still don’t know what causes the disease, for which there is no cure.
There are lingering questions about the drug’s safety, cost, effectiveness, and accessibility and we met with Dr. Kristina Zdanys and Dr. Yazeed Maghaydah, co-directors of the James EC Walker Memory Assessment Program at the UConn Center on Aging to learn more.
Who benefits from this new drug and how does it work?
Maghaydah: The approval of Leqembi, the first treatment for one type of dementia known as Alzheimer’s disease was based on a major study that showed some moderate effect after 18 months of the treatment used to assess the patient’s function so that is a big step and a new era in Alzheimer’s disease. The approval is targeting a very early stage of Alzheimer’s disease dementia specifically described as mild Alzheimer’s and those with mild cognitive impairment that is approved to be caused by Alzheimer’s disease pathology.
Zdanys: Leqembi is a breakthrough monoclonal antibody that targets amyloid, which means that it’s removing amyloid, the protein that we see build up in the brains of patients with Alzheimer’s. However, even with the removal of the amyloid it doesn’t reverse memory loss.
I think it’s important to emphasize that patients receiving the drug may not notice a benefit. Leqembi doesn’t stop or reverse memory decline, and it doesn’t cure Alzheimer’s. The clinical trial showed a slight slowing of the progression, but because there wouldn’t be a version of the patient not on the medication the families are still going to observe ongoing decline, it will just be slower than if they hadn’t taken it.
How is the drug administered and what tests are required by the FDA?
Maghaydah: Lequmbi is administered as an infusion in a specialized infusion center every two weeks. An initial MRI would need to take place prior to the first infusion and repeated MRIs would be needed to monitor the serious side effects of the medication.
Before initiating this anti-amyloid treatment, the prescribing information requires that a physician confirms the presence of beta-amyloid plaques. The FDA does not specify a diagnostic tool to determine elevated beta-amyloid, but tools such as a Brain amyloid PET scan or Cerebrospinal Fluid analysis, that require a lumbar puncture (spinal tap)) are the current practice, blood tests for Beta-Amyloid are validated and becoming more available.
Zdanys: Here at the James EC Walker Memory Assessment Program at UConn Health, we have the specialists and capability of performing those advanced tests and providing a proper diagnosis to determine the right treatment option.
How does one determine if this new drug is appropriate for them?
Maghaydah: Not every patient with an Alzheimer’s diagnosis based only on a clinical evaluation qualify for this kind of medicine. There should be more sophisticated or advanced testing to confirm the presence of biomarkers of Alzheimer’s disease. Patients need to get tested to rule out contraindications for the medicine and conditions that may increase the risk of side effects, specifically risk of Intracranial bleeding. Patients should be seen in a specialized clinic that focuses on memory issues and dementia evaluation and care.
Zdanys: Those patients who qualify for Leqembi are a small selective group. Individuals should talk with their doctors to develop a treatment plan that is right for them, including weighing the benefits and risks of all approved therapies.
What are the side effects?
Magahaydah: All drugs have side effects. As with other anti-amyloid treatments in this class of drugs, lecanemab most commonly reported side effects were infusion-related reactions, headache, falls, and amyloid-related imaging abnormalities (ARIA). ARIA is a serious side effect that requires regular MRI studies during treatment for monitoring and detection. it is two kinds; intracranial bleeding or edema based on any new symptoms further evaluation and imaging (MRI) could be done. If the bleeding or edema is significant the treatment needs to be discontinued.
How long do patients stay on this medication and when will it be available?
Zdanys: We don’t know how long patients will need to be on this medication. The study was initially for 18 months, and we will need to see longer-term data to help us figure that out.
It may take time to get people started on the drug as there are many processes and procedures that will need to be implemented. UConn Health is currently working with all relevant departments to determine the execution of providing Leqembi.
What other options are available for those with Alzheimer’s and related dementias?
Not everybody is going to be a candidate for this medication, however, at UConn Health we have a variety of support and treatment strategies for people with Alzheimer’s disease and support for their caregivers as well so there are other options for them. Supportive care and educating the caregiver remains the art of managing dementia and the Memory Assessment Program at the UConn Center of Aging is here to help.
More information on Alzheimer’s disease, dementia, and other memory issues as well as the services and expertise of the Center on Aging at UConn Health can be found at Center on Aging or by calling 1-84-GET-UCONN.