Target Audience:

Who should attend:

• Clinical faculty from the University of Pittsburgh School of Pharmacy
• Clinical staff pharmacists employed by the University of Pittsburgh Medical Center and deployed throughout the hospital campus in unit based roles and centrally in the department of pharmacy's main pharmacy
• Student pharmacy interns currently working within the department of pharmacy
• Certified Pharmacy Technicians

Abstract
Alzheimer’s disease (AD) is a slow progressive neurocognitive disease characterized by declines in cognition, physical functioning, and memory as well as personality and behavioral changes. In 2021, it was estimated that 6.2 million Americans aged 65 and older are living with Alzheimer’s dementia. AD is the sixth leading cause of death in the United Sates (US) and in 2016 was the sixth most burdensome disease or injury. One neuropathological characteristic of AD is an accumulation of beta-amyloid (plaques) and protein tau (tangles) which contribute to damage and death of neurons. AD accounts for 60-80% of cases of dementia. Current pharmacologic therapy available for AD contribute to the neurocognitive symptoms of AD, however, no disease-modifying therapies that treat the underlying pathology of the disease are available. Previous disease-modifying therapies such as bapineuzumab and solanezumab were unsuccessful in demonstrating benefit. There is an unmet need for effective treatment of Alzheimer’s disease. On June 7th, 2021, the US Food and Drug (FDA) approved Biogen and Eisai’s Alzheimer’s disease therapy, Aduhelm™ (aducanumab-avwa). Aducanumab is an amyloid beta-directed antibody indicated for the treatment of Alzheimer’s disease. This medication was approved under the accelerated approval pathway based on reduction in amyloid beta plaques observed in the clinical trials. The FDA approval of aducanumab has generated controversy surrounding the studies, clinical efficacy, adverse events, and cost. Several large hospital systems decided against adding aducanumab to their formularies because of lack of evidence of clinical benefit and safety concerns of aducanumab. This presentation will review the literature for aducanumab and discuss potential place in therapy for clinical practice.

Educational Objectives:

Upon successful completion of this continuing pharmacy education program, the participant should be able to:

• Discuss the current treatment options of Alzheimer’s disease  
• Explain the literature/controversy regarding aducanumab
• Identify aducanumab’s place in therapy 
  

Pharmacy Continuing Education Credits In support of improving patient care, the University of Pittsburgh is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. The assigned universal program number(s) is JA4008223-0000-23-113-H01-P.  This knowledge-based activity provides 1  contact hours of continuing pharmacy education credit. Disclaimer Statement:  The information presented at this activity represents the views and opinions of the individual presenters, and does not constitute the opinion or endorsement of, or promotion by, the UPMC Center for Continuing Education in the Health Sciences, UPMC / University of Pittsburgh Medical Center or Affiliates and University of Pittsburgh School of Medicine.  Reasonable efforts have been taken intending for educational subject matter to be presented in a balanced, unbiased fashion and in compliance with regulatory requirements. However, each program attendee must always use his/her own personal and professional judgment when considering further application of this information, particularly as it may relate to patient diagnostic or treatment decisions including, without limitation, FDA-approved uses and any off-label uses.

Suggested Additional Reading & Joint Accreditation Statement - Note: This Accreditation Statement Supersedes All Other Statements:

Suggested Additional Reading:

1. FDA grants accelerated approval for ADUHELM™ as the first and only Alzheimer’s disease treatment to address a defining pathology of the disease. Biogen. Published June 7, 2021. Accessed October 25, 2021. https://investors.biogen.com/news-releases/news-release-details/fda-grants-accelerated-approval-aduhelmtm-first-and-only?cid=aff-aduhelm-hp_cta_biogen-app_news_release.
2. Aducanumab (marketed as Aduhelm) information. Food and Drug Administration. Updated July 8, 2021. Accessed October 25, 2021. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/aducanumab-marketed-aduhelm-information.
3. Aduhelm [package insert]. Cambridge, Ma: Biogen Inc. 2021
4. Peripheral and Central Nervous System (PCNS) Drugs Advisory Committee Meeting November 6, 2020. Food and Drug Administration. Accessed December 6, 2021. https://www.fda.gov/media/143502/download.
5. Tampi RR, Forester BP, Agronin M. Aducanumab: evidence from clinical trial data and controversies. Drugs Context. 2021;10:2021-7-3. Published 2021 Oct 4. doi:10.7573/dic.2021-7-3
6. Alzheimer’s Association, 2021 Alzheimer’s Disease Facts and Figures. Alzheimer’s Dement 2021; 17(3). https://www.alz.org/media/Documents/alzheimers-facts-and-figures.pdf
7. Kumar A, Singh A, Ekavali. A review on Alzheimer's disease pathophysiology and its management: an update. Pharmacol Rep. 2015;67(2):195-203. doi:10.1016/j.pharep.2014.09.004.
8. Neurocognitive disorders. In: Diagnostic and Statistical Manual of Mental Disorders: DSM-5, 5e. American Psychiatric Association; 2013.
9. Young KD. Medicare Intends to Limit Payment for Controversial Alzheimer’s Drug. Medscape. Published January 11, 2022. Accessed January 12, 2022. https://www.medscape.com/viewarticle/966428?uac=118655FY&faf=1&sso=true&impID=3941092&src=wnl_newsalrt_220111_MSCPEDIT_CMS

Joint Accreditation Statement - this statement supersedes any other statement on this page
In support of improving patient care, the University of Pittsburgh is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.
Pharmacy (CPE) - This knowledge-based activity provides 1.0 contact hours of continuing pharmacy education credit.
Other health care professionals will receive a certificate of attendance confirming the number of contact hours commensurate with the extent of participation in this activity.