Listen to Ron's Interview with Elizabeth Smith-Boivin
What’s the Latest Research in the Global Fight against Alzheimer’s?
June is Alzheimer’s and Brain Awareness Month, and today’s episode features Elizabeth (Beth) Smith-Boivin, the Executive Director of the Alzheimer’s Association Northeastern New York Chapter. Each year at this time, the Alzheimer’s Association helps promote a global dialogue about Alzheimer’s, which affects more than 6 million people across the U.S., two-thirds of them women. Today’s episode coincides with The Longest Day—the summer solstice —a special day when thousands of participants from across the world create unique programs to raise funds and awareness for the care, support and research efforts of the Alzheimer’s Association. In her conversation with Host Ron Roel, Beth Smith-Boivin focuses on the latest research aimed at combating this devastating disease. Covering the research landscape as a whole, she will highlight the latest major development—the recent approval by the U.S. Food and Drug Administration of a new drug, Aducanumab, produced by Biogen, as a treatment for Alzheimer’s. This is the first FDA-approved therapy that, while not a cure, may potentially delay cognitive decline from the disease, compared to current medications that only address symptoms. Beth will also describe significant research studies, including a major European research project known as the FINGER study and similar ongoing research in the U.S. known as the Pointer Study. These studies examine how improved diet, increased exercise, and enhanced cognitive training and social activity may have a significant impact on reducing the risk of dementia. In addition, Beth will explain how members of the public can advance Alzheimer’s research by participating in clinical trials through a service called Trial Match, which connects individuals with Alzheimer’s, caregivers and healthy volunteers to current research studies.
Featured Guest: Elizabeth Smith-Boivin
Elizabeth “Beth” Smith-Boivin is Executive Director of the Alzheimer’s Association, Northeastern New York Chapter. Beth’s role as executive director is the continuation of a 35-year career in care of and service to the geriatric community and people with Alzheimer’s Disease and other forms of dementia, including over 30 years of service to the Alzheimer’s Association. Prior to her appointment as executive director of the Northeastern Chapter in 2012, Beth served for 10 years as director of the Alzheimer’s Center of Albany Med. She also served as president of the board of the Northeastern New York chapter and as a member of the Alzheimer’s Association’s National Board of Directors. Beth also was an instructor for the New York State Police and is an appointee to the New York State Governor’s Coordinating Council for Services Related to Alzheimer’s Disease and Other Dementias. She has a Bachelor of Science in social work from Siena College and a Master of Science in health services administration from Sage Graduate School.
Here is the FDA’s announcement of the agency’s accelerated approval of Aducanumab:
FDA NEWS RELEASE
FDA Grants Accelerated Approval for Alzheimer’s Drug
For Immediate Release:
June 07, 2021
Today, the U.S. Food and Drug Administration approved Aduhelm (aducanumab) for the treatment of Alzheimer’s, a debilitating disease affecting 6.2 million Americans. Aduhelm was approved using the accelerated approval pathway, which can be used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments. Accelerated approval can be based on the drug’s effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients, with a required post-approval trial to verify that the drug provides the expected clinical benefit.
“Alzheimer’s disease is a devastating illness that can have a profound impact on the lives of people diagnosed with the disease as well as their loved ones,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Currently available therapies only treat symptoms of the disease; this treatment option is the first therapy to target and affect the underlying disease process of Alzheimer’s. As we have learned from the fight against cancer, the accelerated approval pathway can bring therapies to patients faster while spurring more research and innovation.”
Alzheimer’s is an irreversible, progressive brain disorder that slowly destroys memory and thinking skills, and eventually, the ability to carry out simple tasks. While the specific causes of Alzheimer’s disease are not fully known, it is characterized by changes in the brain—including amyloid plaques and neurofibrillary, or tau, tangles—that result in loss of neurons and their connections. These changes affect a person’s ability to remember and think.
Aduhelm represents a first-of-its-kind treatment approved for Alzheimer’s disease. It is the first new treatment approved for Alzheimer’s since 2003 and is the first therapy that targets the fundamental pathophysiology of the disease.
Researchers evaluated Aduhelm’s efficacy in three separate studies representing a total of 3,482 patients. The studies consisted of double-blind, randomized, placebo-controlled dose-ranging studies in patients with Alzheimer’s disease. Patients receiving the treatment had significant dose-and time-dependent reduction of amyloid beta plaque, while patients in the control arm of the studies had no reduction of amyloid beta plaque.
These results support the accelerated approval of Aduhelm, which is based on the surrogate endpoint of reduction of amyloid beta plaque in the brain—a hallmark of Alzheimer’s disease. Amyloid beta plaque was quantified using positron emission tomography (PET) imaging to estimate the brain levels of amyloid beta plaque in a composite of brain regions expected to be widely affected by Alzheimer’s disease pathology compared to a brain region expected to be spared of such pathology.
The prescribing information for Aduhelm includes a warning for amyloid-related imaging abnormalities (ARIA), which most commonly presents as temporary swelling in areas of the brain that usually resolves over time and does not cause symptoms, though some people may have symptoms such as headache, confusion, dizziness, vision changes, or nausea. Another warning for Aduhelm is for a risk of hypersensitivity reactions, including angioedema and urticaria. The most common side effects of Aduhelm were ARIA, headache, fall, diarrhea, and confusion/delirium/altered mental status/disorientation.
Under the accelerated approval provisions, which provide patients suffering from the disease earlier access to the treatment, the FDA is requiring the company, Biogen, to conduct a new randomized, controlled clinical trial to verify the drug’s clinical benefit. If the trial fails to verify clinical benefit, the FDA may initiate proceedings to withdraw approval of the drug.
Aduhelm was granted Fast Track designation, which seeks to expedite the development and review of drugs that are intended to treat serious conditions where initial evidence showed the potential to address an unmet medical need.
Aduhelm is made by Biogen of Cambridge, Massachusetts.
For more information about the Alzheimer Association’s research, support programs and services, visit www.alz.org.
The Alzheimer’s Association is a nationwide organization offers community education programs (now online) for the general public; caregiver training and information about dementia; early-stage social engagement programs; caregiver support groups and a 24/7 Help Line (800-272-3900). The association also offers several online tools, including the Alzheimer’s Navigator (www.alzheimersnavigator.org), which helps caregivers create a personalized action plan; and ALZConnected (www.alzconnected.org), the association’s online message boards with more than 50,000 members who share their ideas and experiences. In addition, the organization is the world’s largest nonprofit funder of Alzheimer’s research. Its TrialMatch program (www.trialmatch.org) is a free matching service that connects individuals living with Alzheimer’s, caregivers, and volunteers to local clinical trials seeking participants.