Clinical Trials and Tribulations in the COVID-19 Era

Weinberg, Marc S.; Patrick, Regan; Schwab, Nadine A.; Owoyemi, Praise; May, Rose; McManus, Alison J.; Gerber, Jessica; Harper, David G.; Arnold, Steven E.; Forester, Brent P.

doi:10.1016/j.jagp.2020.05.016

Cited by 19 publications

(17 citation statements)

References 15 publications

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“…Additionally, increased hopelessness was reported in subjects with AD after interruption of experimental trials on potential disease-modifying drugs. This behavior was induced by the sudden withdrawal of the social support from clinical care staff and their participation in the trial ( 17 ). The onset or worsening of elation/euphoric mood was poorly reported, and when it was, the occurrence of it was low ( 15 ).…”

Section: Resultsmentioning

confidence: 99%

Neuropsychiatric Symptoms in Elderly With Dementia During COVID-19 Pandemic: Definition, Treatment, and Future Directions

et al. 2020

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Background Neuropsychiatric symptoms (NPS) of dementia, such as anxiety, depression, agitation, and apathy, are complex, stressful, and costly aspects of care, and are associated to poor health outcomes and caregiver burden. A steep worsening of such symptoms has been reported during Coronavirus Disease 2019 (COVID-19) pandemic. However, their causes, their impact on everyday life, and treatment strategies have not been systematically assessed. Therefore, the aim of this review is to provide a detailed description of behavioral and psychopathological alterations in subjects with dementia during COVID-19 pandemic and the associated management challenges. Methods A PubMed search was performed focusing on studies reporting alterations in behavior and mood and treatment strategies for elderly patients with dementia, in accordance with PRISMA guidelines. The following search strategy was utilized: (COVID* OR coronavirus OR “corona vir*” OR SARS-CoV-2) AND (dementia OR demented OR dement* OR alzheimer* OR “pick’s disease” OR “lewy body” OR “mild cognitive” OR mild cognitive impairment OR MCI). Results Apathy, anxiety and agitation are the most frequently NPS during the COVID-19 pandemic and are mainly triggered by protracted isolation. Most treatment strategies rely on pharmacotherapy; technology is increasingly utilized with mixed results. Conclusions NPS of dementia during COVID-19 appear to arise from social restrictions occurring as a consequence of the pandemic. Implementation of caregiver support and the presence of skilled nursing home staff are required to restore social interaction and adjust technological support to the patients’ needs.

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Section: Resultsmentioning

confidence: 99%

Neuropsychiatric Symptoms in Elderly With Dementia During COVID-19 Pandemic: Definition, Treatment, and Future Directions

et al. 2020

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“…6 The Federation of Italian Cooperative Oncology group issued a brief commentary and practice indications for drug studies. 7 Other publications have included clinical trials for Alzheimer's research, 8 and a review for guidance in head and neck research. 9 At the time of writing, no published studies measuring the comprehensive impact of COVID-19 on research are available, and while this study focuses specifically on neurovascular research and trials, disruptions captured may well be generalizable to United States clinical trials in other medical specialties.…”

Section: Discussionmentioning

confidence: 99%

Neuroendovascular clinical trials disruptions due to COVID-19. Potential future challenges and opportunities

Ansaar

Leslie‐Mazwi

Fargen

et al. 2020

J NeuroIntervent Surg

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To assess the impact of COVID-19 on neurovascular research and deal with the challenges imposed by the pandemic.MethodsA survey-based study focused on randomized controlled trials (RCTs) and single-arm studies for acute ischemic stroke and cerebral aneurysms was developed by a group of senior neurointerventionalists and sent to sites identified through the clinical trials website (https://clinicaltrials.gov/), study sponsors, and physician investigators.ResultsThe survey was sent to 101 institutions, with 65 responding (64%). Stroke RCTs were being conducted at 40 (62%) sites, aneurysm RCTs at 22 (34%) sites, stroke single-arm studies at 37 (57%) sites, and aneurysm single-arm studies at 43 (66%) sites. Following COVID-19, enrollment was suspended at 51 (78%) sites—completely at 21 (32%) and partially at 30 (46%) sites. Missed trial-related clinics and imaging follow-ups and protocol deviations were reported by 27 (42%), 24 (37%), and 27 (42%) sites, respectively. Negative reimbursements were reported at 17 (26%) sites. The majority of sites, 49 (75%), had put new trials on hold. Of the coordinators, 41 (63%) worked from home and 20 (31%) reported a personal financial impact. Remote consent was possible for some studies at 34 (52%) sites and for all studies at 5 (8%) sites. At sites with suspended trials (n=51), endovascular treatment without enrollment occurred at 31 (61%) sites for stroke and 23 (45%) sites for aneurysms. A total of 277 patients with acute ischemic stroke and 184 with cerebral aneurysms were treated without consideration for trial enrollment.ConclusionWidespread disruption of neuroendovascular trials occurred because of COVID-19. As sites resume clinical research, steps to mitigate similar challenges in the future should be considered.

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“…The COVID-19 pandemic has compelled most ongoing clinical trials in the AD field to be put on hold for a few months, affecting participants' recruitment, administration of medication infusions and follow-up visits (Weinberg et al, 2020). This has caused a significant disruption in the management of clinical trials, with the need of protocol amendments to deal with missing data, deviations, loss of participants and allowing the use of telemedicine.…”

Section: Covid-19 Effects On Dementia Research and Clinical Trialsmentioning

confidence: 99%

Cognitive and Neuropsychiatric Manifestations of COVID-19 and Effects on Elderly Individuals With Dementia

Alonso‐Lana

Marquié

Ruiz

et al. 2020

Front. Aging Neurosci.

147

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The coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has rapidly spread worldwide and has had unprecedented effects in healthcare systems, economies and society. COVID-19 clinical presentation primarily affects the respiratory system causing bilateral pneumonia, but it is increasingly being recognized as a systemic disease, with neurologic manifestations reported in patients with mild symptoms but, most frequently, in those in a severe condition. Elderly individuals are at high risk of developing severe forms of COVID-19 due to factors associated with aging and a higher prevalence of medical comorbidities and, therefore, they are more vulnerable to possible lasting neuropsychiatric and cognitive impairments. Several reports have described insomnia, depressed mood, anxiety, post-traumatic stress disorder and cognitive impairment in a proportion of patients after discharge from the hospital. The potential mechanisms underlying these symptoms are not fully understood but are probably multifactorial, involving direct neurotrophic effect of SARS-CoV-2, consequences of long intensive care unit stays, the use of mechanical ventilation and sedative drugs, brain hypoxia, systemic inflammation, secondary effects of medications used to treat COVID-19 and dysfunction of peripheral organs. Chronic diseases such as dementia are a particular concern not only because they are associated with higher rates of hospitalization and mortality but also because COVID-19 further exacerbates the vulnerability of those with cognitive impairment. In patients with dementia, COVID-19 frequently has an atypical presentation with mental status changes complicating the early identification of cases. COVID-19 has had a dramatical impact in long-term care facilities, where rates of infection and mortality have been very high. Community measures implemented to slow the spread of the virus have forced to social distancing and cancelation of cognitive stimulation programs, which may have contributed to generate loneliness, behavioral symptoms and worsening of cognition in patients with dementia. COVID-19 has impacted the functioning of Memory Clinics, research programs and clinical trials in the Alzheimer's field, triggering the

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Clinical Trials and Tribulations in the COVID-19 Era

Cited by 19 publications

References 15 publications

Neuropsychiatric Symptoms in Elderly With Dementia During COVID-19 Pandemic: Definition, Treatment, and Future Directions

Neuropsychiatric Symptoms in Elderly With Dementia During COVID-19 Pandemic: Definition, Treatment, and Future Directions

Neuroendovascular clinical trials disruptions due to COVID-19. Potential future challenges and opportunities

Cognitive and Neuropsychiatric Manifestations of COVID-19 and Effects on Elderly Individuals With Dementia

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