Clinical Trials and Tribulations in the COVID-19 Era

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Highlights

  • In the midst of the COVID-19 pandemic, how have researchers, clinicians, and participants of geriatric clinical trials been affected, and what are the implications for postpandemic research of neurocognitive disorders?

  • Rapidly shifting institutional, sponsor, state and federal guidelines have resulted in halted enrollments, missed visits, interrupted medication delivery and delayed infusions and have challenged the limits of tolerance for continuing key studies on potentially disease-modifying treatments for Alzheimer’s. Clinicians, research coordinators, and participants have responded to the chaotic environment by testing new models of care and assessment, pushing for creative adaptations in research methodology and data collection.

  • Researching treatments for a devastating disease during a global emergency carries unforeseen challenges, limitations, risks, and psychosocial consequences, but may lead to new strategies that improve efficiency, and are more crisis-resistant in the future.

ABSTRACT

Advances in treating and preventing Alzheimer disease and other neurocognitive disorders of aging arise from rigorous preclinical and clinical research, with randomized controlled treatment trials as the last and definitive test. The COVID-19 pandemic has greatly disrupted ongoing interventional studies and researchers are scrambling to find ways to safely continue this critical work amidst rapidly shifting guidelines from sponsors, institutions, and state and federal guidelines. Here the authors describe novel approaches and work-flow adaptations to study visits, drug delivery and interim and endpoint safety and outcomes assessments to avoid sacrificing years of preparation and substantial financial investments, to work in the best interest of participants and their caregivers, and to continue on the path toward discovering disease-modifying treatments for the millions of individuals impacted by major neurocognitive disorders.

Key Words

As of May 2020, there are 275 ongoing interventional trials for Alzheimer disease (AD) in the United States which are recruiting, active and no longer recruiting, or not yet recruiting subjects for enrollment. There have been no new drugs approved for this disease since 2003, and to date there is still no approved disease-modifying drug aiding the over five million people diagnosed with AD and their caregivers in the United States.

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The Alzheimer’s Association
2020 Alzheimer’s disease facts and figures.