By Alison Lynn, PMC associate director of social work

There was a time when it felt shameful to tell someone you go to therapy. Luckily, over the past few decades, it’s become increasingly normal to be open about ones need for professional support. Particularly post-pandemic, it is impossible to scroll through Instagram without seeing some kind of infographic or inspirational story related to mental health. But, despite this wealth of new information, many still don’t know what actually happens at therapy in enough detail to decide whether it might be helpful for them. What happens in the treatment room (or, on Zoom) can feel mysterious and intimidating.

In this two-part series, I’ll explain how to get started and what to expect from a first session, as well as how therapy can specifically help individuals with Alzheimer’s disease and their family caregivers.

On January 11, the Centers for Medicare and Medicaid Services (CMS) announced its much-anticipated coverage proposal for monoclonal antibody treatments that target amyloid for the treatment of Alzheimer’s disease. According to the proposed policy, this class of drugs, which includes aducanumab, also known by the brand name Aduhelm, would be covered for people with Medicare only if they are enrolled in qualifying clinical trials.

Penn Memory Center (PMC) Co-Director Jason Karlawish, MD, joined the Dementia Matters podcast to discuss the recent proposal, share his reaction to the decision, and tell you how this coverage policy could impact the development of other Alzheimer’s disease treatments in the future.

Discrimination, mistrust of medical professionals, and other barriers have caused Black and African Americans to be underrepresented among Alzheimer’s disease and related dementias (ADRD) researchers and research participants.

Increasing the representation of Black and African Americans in ADRD research is essential to developing treatments and providing quality care.

Learn more about three featured researchers at PMC who are breaking boundaries and working to advance equity in ADRD research.

Estevana Isaac

Estevana Isaac, MD
Role at PMC: Clinical fellow
Research interest: Disparities in health outcomes for patients with diverse cultural backgrounds

“As a clinical doctor, in addition to providing medical and social support to meet daily needs, I will continue to educate the public, patients, and caregivers to ensure safer environments. As a health services researcher, I intend to focus on solutions to better coordinate care and decrease costs for vulnerable patient populations as such. As a Black woman, I expect that my presence in these arenas continues to decrease biases and open more doors for diverse persons and perspectives, ultimately changing the face of healthcare.”

This past summer, Penn’s Alzheimer’s Disease Research Center (ADRC) held its inaugural session of the Aging Research Summer Internship.

Interns experienced hands-on research in laboratories across the ADRC and day-to-day activities and projects in various areas of the Penn Memory Center, such as communications, social work, clinical care, and neuropsychological testing.

“[The Aging Summer Research Internship] has been so enriching. It will help me towards my goal of becoming a psychiatrist,” said student intern Lorette Thomas.

Interns were paired with a mentor — a faculty member who provided support and guidance throughout the program — and assisted the mentor with their research.

By Daniel Gibbs, MD, retired neurologist and author, and Jason Karlawish, MD, co-director of the Penn Memory Center, geriatrician, and author

Both of us are physicians dedicated to the care of persons living with Alzheimer’s disease. We’ve heard thousands of moving stories from persons struggling with a fading capacity to exercise their free will and their friends and family members devoting time, effort, and resources to care for them. We feel their desperation.  

For one of us, this feeling isn’t simply professional. It’s intensely personal. Nine years ago, Dan retired from practicing neurology because of mild cognitive impairment (MCI) caused by Alzheimer’s disease.   

We wish we could have celebrated in June, when the Food and Drug Administration (FDA) approved Biogen’s drug aducanumab, marketed as Aduhelm, for the treatment of Alzheimer’s disease. We wish we were now condemning the Centers for Medicare and Medicaid Services (CMS) for its recent proposal to limit coverage of the drug to patients enrolled in a clinical trial of Aduhelm, known as “coverage with evidence development.” Instead, we weren’t celebrating in June, and now we thank Medicare for its courageous and reasonable proposal.  

For the Spring of 2022, the Penn Memory Center is offering a wide range of programs for patients, caregivers, and families. All programs are free, virtual, and require registration. Tap on the title of the program to register and for more information.

• Grief Yoga, first Thursday of every month at 11 a.m. starting Jan. 5
• Cognitive Comedy, Tuesdays at 1:30 p.m. starting Jan. 24
• Creative Expressions Through Music, Tuesdays at 11:30 a.m. starting Jan. 30
• Virtual Caregiver Forums, last Tuesday of every month at 11 a.m. starting Jan. 24
• Shake It Up!, Wednesdays at 12:30 p.m. starting Jan. 26
• Mindfulness and Meditation, Thursdays at 1 p.m. starting Jan. 19
• Applications are now being accepted for our three Caregiving Classes.

These programs are free to patients/families seen at the Penn Memory Center and made possible from the philanthropic Caring Difference fund. Please consider making a donation so that we are able to continue offering support programs such as this.

If you are not affiliated with the Penn Memory Center, you are welcome to join this class/program if you make a donation of any amount to the Caring Difference fund.

Tap here to donate. 

On January 11, the Centers for Medicare and Medicaid Services (CMS) released a plan for Medicare coverage of Aduhelm (aducanumab). Aduhelm was FDA-approved in June 2021 for the treatment of Alzheimer’s disease (AD). The CMS plan is a program called Coverage with Evidence Development (CED). This evidence will be developed using a randomized controlled trial.

The CMS proposal is open to public comment for 30 days. The public can submit comments on the proposal on the CMS website.

Please join us for a virtual community discussion about this proposal at 4 p.m. Wednesday, January 19. Penn Memory Center (PMC) Co-Director Jason Karlawish, MD, and UPenn Medicare expert Allison K. Hoffman, JD, will review the proposal and its potential impact on PMC, our research participants, and our patients.

Please submit questions anytime before the event via this form.

Register for Community Discussion

If you have limited internet access, please email Terrence Casey at terrence.casey@pennmedicine.upenn.edu for more information on attending the event via telephone. This event will be recorded and uploaded to the PMC YouTube channel. 

In a recent article, Emily Largent, PhD, JD, RN, member of the Penn Program on Precision Medicine for the Brain (P3MB), argues that Alzheimer’s disease testing and results disclosure should be brought into the 21st Century Cures Act (Cures Act). Here are some key takeaways from Dr. Largent’s article:

• Tests that show either the risk of developing Alzheimer’s disease (AD) or the presence of AD pathology are becoming more frequent and are predicted to become a regular aspect of health care in the near future.
• The Cures Act requires patients to be able to receive these test results immediately and electronically, without certainty that a clinician will be there to explain the result or that the patient received educational materials about the nuances and uncertainties of AD testing.
• Patients and families can understand AD gene and biomarker test results with the appropriate education.
  • Reports of test results should use plain and easy to comprehend language, not an abundance of medical jargon.
  • Educational materials should be evidence-based and be made widely available.
  • There should be increased access to expert postdisclosure education and counseling.

Dr. Largent’s full article is in JAMA Neurology. There is a paywall.

At the Mayo Clinic’s Conference on Brain Health & Dementia, PMC Co-director Jason Karlawish, MD, was a featured speaker. Dr. Karlawish told three stories of significant figures that demonstrate the influence of politics and culture on Alzheimer’s disease research and care.

It has been almost two years since the COVID-19 pandemic impacted us all, and almost six months since we last shared with you the importance of vaccination. We have seen many changes to procedures and daily life — adapting as we learn new information. Like us, viruses also learn ways to adapt. There is an emergence of a new COVID-19 variant called Delta. Viruses change and adapt overtime, acting in new ways. The longer a virus circulates, the more it can change. This is called a variant. As the Delta variant has emerged, we would like to encourage you to get your COVID-19 vaccinations.

Below are some facts about the Delta variant from the Centers for Disease Control:

• The Delta variant is more contagious
• Some data suggest the Delta variant might cause more severe illness than previous variants in unvaccinated people
• Unvaccinated people remain the greatest concern
• Fully vaccinated people with Delta variant breakthrough infections can spread the virus to others. However, vaccinated people appear to spread the virus for a shorter time
• Vaccines in the US are highly effective, including against the Delta variant

Medical student at PCOM, member of Alpha Phi Alpha, and Penn Memory Center community partner Frederick Okoye shared his thought on the COVID-19 vaccination. “It’s just peace of mind. It’s just looking out for your fellow man or woman in your communities. Looking out for our elderly, looking out for our immunocompromised. It’s doing your civil duty.” Okoye said. “If you’re lucky enough to get the vaccine, I strongly encourage anybody to do so.”

Training programs to advance care, research, and equity

The Penn Memory Center offers valuable hands-on experience and mentorship through training programs in the areas of social work, research, neuropsychology, communications, and clinical care and is dedicated to creating training opportunities for people from underrepresented racial and ethnic groups. These efforts play a vital role in advancing Alzheimer’s disease and related dementias (ADRDs) care and research and closing health disparity gaps. Funding of our training programs relies on generous donations.

Quality Care Matters

The Penn Memory Center’s expert team of health professionals is dedicated to providing the highest standard of clinical care to patients. This quality care is difficult to find elsewhere in Philadelphia, and the number of PMC patients is increasing. We need your support to continue serving our growing patient community.

PMC programming: inclusive, engaging, and free-to-all

From our classic, evidence-based programs such as Caregiver Educational class and Memory Cafe to newer, trailblazing programs like Mindfulness & Meditation Class, Cognitive Comedy, and Healthy Aging Series, PMC is always growing and evolving to best serve its families and build community. These important programs rely on philanthropic support to keep them running and free-to-all.

Research is made possible by you

Research moves us closer to a treatment and to a better future for patients and their loved ones. At PMC, we conduct a variety of research — from clinical trials testing novel drugs to studies about patient and caregiver experiences. Our dedicated participants and funding make this research possible.

Community outreach promotes health equity

In collaboration with our community partners, PMC provides health education, services, research, and job opportunities to the West Philadelphia community in effort to create more equitable health outcomes. This work relies on the funding of our generous supporters.

Oct. 3 marks the start of the Penn Memory Center’s annual fundraiser, A Celebration of Hope! This is an asynchronous virtual event that features an online auction. The auction will open for bidding on Oct. 5 at 12 p.m. and close on Oct. 8 at 12 p.m. Click here to register for our auction.

A Celebration of Hope welcome video

Cognitive Comedy • Tuesdays 1:30 – 3:00 p.m.

Cognitive Comedy is a free improv comedy workshop for people with cognitive impairment and their loved ones. Participants can get out of their own heads and experience “group mind” while learning about improv comedy. This program starts on September 21. Register for Cognitive Comedy.

Dr. Jason Karlawish and Dr. Emily Largent offer their takes on using driving performance and credit scores to predict the onset of dementia. Should entities like auto insurance companies have access to test results of these predictors? Dr. Largent weighs in.

By Cait Kearney

Melissa Johnston Esparza is moving on from the Penn Memory Center (PMC) after three years as a clinical research coordinator.  

“PMC is a wonderful organization, and having been a part of helping advance its mission has been a rewarding experience I will cherish forever,” Johnston Esparza said.  

Johnston Esparza joined PMC as a clinical research coordinator for the REVEAL-SCAN Study (Risk Evaluation and Education of Alzheimer’s Disease: The Study of Communicating Amyloid Neuroimaging), a project investigating the impact of learning one’s personal risk of having Alzheimer’s disease on thinking and health behaviors. 

“Melissa is a stellar coordinator. She stepped into a study that was in distress and quickly turned it around and into a great scientific success,” said Jason Karlawish, MD, co-director of PMC and co-principal investigator of the REVEAL-SCAN Study. 

In JAMA Network Medical News, Dr. Jason Karlawish expressed his concern that Aduhelm’s approval will have a negative impact on the enrollment of future clinical trials.

By Cait Kearney

Matthew Ferrara, MS Ed., is leaving the Penn Memory Center (PMC) after three years as a clinical research coordinator.  

“Matt has been an absolute delight to work with in his time here at the PMC,” said PMC Co-Director David Wolk, MD, “Matt will be missed by our faculty, staff, and research participants.” 

Ferrara joined PMC in 2018 as a coordinator for PMC’s largest study — the Aging Brain Cohort (ABC) Study. Data collected through the ABC Study is used by scientists across the nation and the world to research Alzheimer’s disease and life-long brain health. 

“He displayed a remarkable dedication to the success of the ABC study to the benefit of our research participants and the numerous studies that depend on these data,” Dr. Wolk said.  

In a recent Vox article, assistant director of social work Alison Lynn, MSW, PMC researcher Emily Largent, PhD, JD, RN, and PMC co-director Jason Karlwish, MD, offered insight into the uncertainties people with an Alzheimer’s disease diagnosis and their caregivers may face and discussed the added stress they may feel from the controversy around Aduhelm. (Image: Christina Animashaun/Vox)

The Food and Drug Administration (FDA) has revised its recommendation of who should receive Aduhelm, the controversial Alzheimer’s disease drug approved by the FDA last month.

The original label stated the treatment was for anyone with Alzheimer’s disease, encompassing six million Americans. Under the new label, the FDA recommends Aduhelm to “patients with mild cognitive impairment or mild dementia stage of disease,” reflecting the population tested in clinical trials and cutting the number of eligible Americans to about two million.

“The revision of this label is yet another piece of evidence that should cause the American public to be concerned about how FDA is practicing its regulatory science,” PMC co-director Dr. Jason Karlawish told the New York Times.

Dr. Jason Karlawish, co-director of PMC, was quoted by The Washington Post regarding the negative potential consequences of the Food and Drug Administration’s approval of Aduhelm.

“Companies are companies, I can’t fault them for doing what companies do, but we have now unleashed drugs that we are not sure what the benefits are, and that could have enormous consequences,” said Dr. Jason Karlawish.

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.