An Alzheimer's Disease Research Center
PMC co-director Dr. Jason Karlawish was quoted in The New York Times regarding the uncertainties surrounding Aduhelm, the Alzheimer’s disease drug recently approved by the Food and Drug Administration. When asked if adults should consider Aduhelm, Dr. Karlawish said, “The F.D.A. has passed the determination along to the American family.”
Understanding the way that Alzheimer’s disease and related dementias affect loved ones is a hard concept for many adults to wrap their head around. For children, it might seem tougher to explain and comprehend.
Alison Lynn, MSW, LCSW, associate director for social work at the Penn Memory Center, suggests children’s books as a way to introduce a diagnosis to them and its effects on their relationships with older loved ones.
“We get a fair number of questions regarding grandchildren in families that live together intergenerationally,” Lynn said. “Questions are more commonly focused on what to do after the diagnosis and the real-world issues that arise than about how to explain the diagnosis itself. Situations like these have also increased due to the pandemic.”
Children’s books that address dementia and Alzheimer’s disease help relay the concepts that are less concrete and harder to grasp.
By Varshini Chellapilla
At the Penn Memory Center and the Alzheimer’ Disease Research Center at the University of Pennsylvania, we are committed to training the next generation of clinicians and researchers. The Christopher M. Clark Scholars program was created to encourage and guide early career researchers as they study the various aspects of Alzheimer’s disease, mild cognitive impairment, cognitive aging, and lifelong brain health.
This year’s scholars are Lasya Sreepada, Xueying Lyu, Brianna Morgan, Kyra O’Brien, and Nicole Nissim, who come from diverse backgrounds in bioengineering, nursing and clinical research.
Christopher M. Clark was the founding director of the Penn Memory Center. Among his many accomplishments were his role in the team that demonstrated the ability of a florbetapir PET scan to detect brain deposits of beta-amyloid, his co-development of the Dementia Severity Rating Scale, and contributions to the development of therapies for Alzheimer’s disease.
The scholars program at PMC was renamed last year to be the Christopher M. Clark Scholars Program to honor Dr. Clark’s achievements as well as his dedication to research and promoting awareness of Alzheimer’s disease.
This past Wednesday, the Penn Memory Center held a community event for PMC patients and families led by co-directors Drs. Jason Karlawish and David Wolk to discuss the Food and Drug Administration’s (FDA) decision to approve Aduhelm (aducanumab). The focus was the impact of the approval on the PMC’s clinical and research operations.
By Dr. Patrizia Cavazzoni, Director, FDA Center for Drug Evaluation and Research
Today FDA approved Aduhelm (aducanumab) to treat patients with Alzheimer’s disease using the Accelerated Approval pathway, under which the FDA approves a drug for a serious or life-threatening illness that may provide meaningful therapeutic benefit over existing treatments when the drug is shown to have an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients and there remains some uncertainty about the drug’s clinical benefit.
This approval is significant in many ways. Aduhelm is the first novel therapy approved for Alzheimer’s disease since 2003. Perhaps more significantly, Aduhelm is the first treatment directed at the underlying pathophysiology of Alzheimer’s disease, the presence of amyloid beta plaques in the brain. The clinical trials for Aduhelm were the first to show that a reduction in these plaques—a hallmark finding in the brain of patients with Alzheimer’s—is expected to lead to a reduction in the clinical decline of this devastating form of dementia.
We are well-aware of the attention surrounding this approval. We understand that Aduhelm has garnered the attention of the press, the Alzheimer’s patient community, our elected officials, and other interested stakeholders. With a treatment for a serious, life-threatening disease in the balance, it makes sense that so many people were following the outcome of this review. Further, the data included in the applicant’s submission were highly complex and left residual uncertainties regarding clinical benefit. There has been considerable public debate on whether Aduhelm should be approved. As is often the case when it comes to interpreting scientific data, the expert community has offered differing perspectives.
At the end of the day, we followed our usual course of action when making regulatory decisions in situations where the data are not straightforward. We examined the clinical trial findings with a fine-tooth comb, we solicited input from the Peripheral and Central Nervous System Drugs Advisory Committee, we listened to the perspectives of the patient community, and we reviewed all relevant data. We ultimately decided to use the Accelerated Approval pathway—a pathway intended to provide earlier access to potentially valuable therapies for patients with serious diseases where there is an unmet need, and where there is an expectation of clinical benefit despite some residual uncertainty regarding that benefit. In determining that the application met the requirements for Accelerated Approval, the Agency concluded that the benefits of Aduhelm for patients with Alzheimer’s disease outweighed the risks of the therapy.
Click the headline or the button below to read this announcement on the FDA website.
Amyloid plaque in the brain. Photo: Adobe
In a recent essay published in STAT News, PMC co-director Dr. Jason Karlawish argued that, given aducanumab’s “incomplete and contradictory” data and the results of an analysis of aducanumab’s effectiveness and value by the Institute for Clinical and Economic Review, the FDA should not approve the drug at this time and stated he will not prescribe it to his patients.
Click the headline or the button below to read this article on STAT News.
Roy H. Hamilton, MD, MS, FAAN, associate professor of neurology and assistant dean for cultural affairs and diversity at University of Pennsylvania’s Perelman School of Medicine, said neurology training would be lacking without an emphasis on racial disparities, especially since many neurologic conditions are more prevalent in minority communities. The neurology department at UPenn began to focus on diversity and inclusion in its training program in 2017, but the initiative is now seen as the core of everything the department does, from hiring to promoting staff to training students and residents.
Dr. Hamilton sees patients in the Penn Memory Center clinic.
Click the headline or the button below to read this article on Neurology Today.
Click the headline or the button below to read this article on PhillyMag.com.
As part of its LiveTalk series, Being Patient spoke with Dr. Jason Karlawish, co-director of the Penn Memory Center and author of “The Problem of Alzheimer’s,” about the advances in dementia research and diagnostics that have allowed for the early detection of Alzheimer’s. Click the headline or the button below to read this article on BeingPatient.com.