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Full-Text Articles in Medicine and Health Sciences

The Alzheimer’S Disease Drug Development Landscape, Pieter Van Bokhoven, Arno De Wilde, Lisa Vermunt, Prisca S. Leferink, Sasja Heetveld, Jeffrey Cummings, Philip Scheltens, Everard G.B. Vijverberg Dec 2021

The Alzheimer’S Disease Drug Development Landscape, Pieter Van Bokhoven, Arno De Wilde, Lisa Vermunt, Prisca S. Leferink, Sasja Heetveld, Jeffrey Cummings, Philip Scheltens, Everard G.B. Vijverberg

Brain Health Faculty Publications

Background: Alzheimer’s disease (AD) is a devastating neurodegenerative disease leading to dementia. The field has made significant progress over the last 15 years. AD diagnosis has shifted from syndromal, based on signs and symptoms, to a biomarker construct based on the pathological hallmarks of the disease: amyloid β deposition, pathologic tau, and neurodegeneration. Numerous genetic risk factors for sporadic AD have been identified, providing further insight into the molecular underpinnings of the disease. For the last two decades, however, drug development for AD has been proven to be particularly challenging. Here, we provide a unique overview of the drug development …


The Costs Of Developing Treatments For Alzheimer’S Disease: A Retrospective Exploration, Jeffrey L. Cummings, Dana P. Goldman, Nicholas R. Simmons-Stern, Eric Ponton Sep 2021

The Costs Of Developing Treatments For Alzheimer’S Disease: A Retrospective Exploration, Jeffrey L. Cummings, Dana P. Goldman, Nicholas R. Simmons-Stern, Eric Ponton

School of Medicine Faculty Publications

Introduction: With the exception of the recent accelerated approval of aducanumab, in over 26 years of research and development (R&D) investment in Alzheimer's disease (AD), only five novel drugs—all for symptomatic treatment only—have reached FDA approval. Here, we estimate the costs of AD drug development during this period in the private sector. Methods: To estimate private R&D funding, we collected information on AD clinical trials (n = 1099; phases 1–4) conducted between January 1, 1995 and June 21, 2021 from various databases. Costs were derived using previously published methodologies and adjusted for inflation. Results: Since 1995, cumulative private expenditures on …


Diabetes Mellitus Affects Working Memory, Dylone C. Braganza, Emmanuel Flores, Lauren A. Crew, Ryan A. Wirt, Andrew A. Ortiz, Adam M. Mcneela, Jefferson W. Kinney, James M. Hyman Aug 2021

Diabetes Mellitus Affects Working Memory, Dylone C. Braganza, Emmanuel Flores, Lauren A. Crew, Ryan A. Wirt, Andrew A. Ortiz, Adam M. Mcneela, Jefferson W. Kinney, James M. Hyman

Spectra Undergraduate Research Journal

Alzheimer’s disease (AD) degrades the brain’s ability to remember, think, and carry out tasks. The exact cause is not known, but several risk factors have been identified, including diabetes mellitus (DM). DM causes elevated blood sugar levels due to reduced insulin production in the pancreas. The linkage between elevated glucose levels and the behavioral impairments are not fully understood, which was the focus of this study. Rats were trained to alternate directions in a maze to receive a reward on consecutive trials. After training, five rats were injected with streptozotocin (STZ), which induces hyperglycemia by injuring pancreatic beta cells. Three …


Aducanumab: Appropriate Use Recommendations, Jeffrey Cummings, P. Aisen, L. G. Apostolova, A. Atri, S. Salloway, M. Weiner Jul 2021

Aducanumab: Appropriate Use Recommendations, Jeffrey Cummings, P. Aisen, L. G. Apostolova, A. Atri, S. Salloway, M. Weiner

School of Medicine Faculty Publications

Aducanumab has been approved by the US Food and Drug Administration for treatment of Alzheimer’s disease (AD). Clinicians require guidance on the appropriate use of this new therapy. An Expert Panel was assembled to construct Appropriate Use Recommendations based on the participant populations, conduct of the pivotal trials of aducanumab, updated Prescribing Information, and expert consensus. Aducanumab is an amyloid-targeting monoclonal antibody delivered by monthly intravenous infusions. The pivotal trials included patients with early AD (mild cognitive impairment due to AD and mild AD dementia) who had confirmed brain amyloid using amyloid positron tomography. The Expert Panel recommends that use …