Toulouse Alzheimer’s Clinical Research Center Recovery After the Covid-19 Crisis: Telemedicine an Innovative Solution for Clinical Research During the Coronavirus Pandemic

Takeda, Catherine; Guyonnet, Sophie; Ousset, Pierre Jean; Soto, María; Vellas, Bruno

doi:10.14283/jpad.2020.32

Cited by 11 publications

(11 citation statements)

References 8 publications

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“…Remote assessments may provide a useful means of testing large numbers of study participants for longitudinal, observational studies as well as for screening for inclusion and follow-up in large-scale prevention/intervention trials, 8 with high acceptance rate in seniors (90% in our study; 88.6% in Takeda et al 8 ). A pilot study on remote assessment revealed that once older adults had coped with a first remote assessment in digital format the dropout was minimal.…”

Section: Implications For Wider Research and Future Considerationsmentioning

confidence: 74%

Transition from physical to virtual visit format for a longitudinal brain aging study, in response to the Covid‐19 pandemic. Operationalizing adaptive methods and challenges

Udeh-Momoh

Jager-Loots

Price

et al. 2020

A&D Transl Res & Clin Interv

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The COVID‐19 pandemic necessitated adaptations to standard operations and management of clinical studies, after lockdown measures put in place by several governments to reduce the spread of SARS‐COV‐2. In this paper, we describe our telehealth strategy developed for transitioning our dementia prevention clinical observational prospective study from face‐to‐face visits to virtual visits, to ensure the ongoing collection of longitudinal data. We share the lessons learned in terms of challenges experienced and solutions implemented to achieve successful administration of study assessments. Our methods will be useful for informing longitudinal observational or interventional studies that require a feasible model for remote data collection, in cognitively unimpaired adults.

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Section: Implications For Wider Research and Future Considerationsmentioning

confidence: 74%

Transition from physical to virtual visit format for a longitudinal brain aging study, in response to the Covid‐19 pandemic. Operationalizing adaptive methods and challenges

Udeh-Momoh

Jager-Loots

Price

et al. 2020

A&D Transl Res & Clin Interv

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“…We cannot afford to discontinue these trials, nor to threaten the validity of the evidence they provide in these situations [ 18 ]. Our group, like others, has been able to come up with ad-hoc plans to cope with the situation and maintain clinical research [ 19 ], but not without great burden. Although the overall results of these ad-hoc plans have been positive, we should not have to rely on this type of site-based initiatives.…”

Section: Discussionmentioning

confidence: 99%

Managing Clinical Trials for Alzheimer’s Disease During the COVID-19 Crisis: Experience at Fundació ACE in Barcelona, Spain

Abdelnour

Antonio

Pérez‐Cordón

et al. 2020

JAD

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Background: The COVID-19 pandemic has brought great disruption to health systems worldwide. This affected ongoing clinical research, particularly among those most vulnerable to the pandemic, like dementia patients. Fundació ACE is a research center and memory clinic based in Barcelona, Spain, one of the hardest-hit countries. Objective: To describe the ad-hoc strategic plan developed to cope with this crisis and to share its outcomes. Methods: We describe participants’ clinical and demographic features. Additionally, we explain our strategic plan aimed at minimizing the impact on clinical trial research activities, which included SARS-CoV-2 RT-PCR and IgG serological tests to all participants and personnel. The outcomes of the plan are described in terms of observed safety events and drop-outs during the study period. Results: A total of 130 patients were participating in 16 active clinical trials in Fundació ACE when the lockdown was established. During the confinement, we performed 1018 calls to the participants, which led to identify adverse events in 26 and COVID-19 symptoms in 6. A total of 83 patients (64%) could restart on-site visits as early as May 11, 2020. All SARS-CoV-2 RT-PCR diagnostic tests performed before on-site visits were negative and only three IgG serological tests were positive. Throughout the study period, we only observed one drop-out, due to an adverse event unrelated to COVID-19. Discussion: The plan implemented by Fundació ACE was able to preserve safety and integrity of ongoing clinical trials. We must use the lessons learned from the pandemic and design crisis-proof protocols for clinical trials.

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“…Virtual visits could also be used for trial components that do not require technically invasive procedures. The INSPIRE study team at Toulouse University Hospital tested this strategy following the first COVID lockdown in France and found a high rate of acceptance among participants ( 33 ).…”

Section: Moving Forwardmentioning

confidence: 99%

Using Digital Tools to Advance Alzheimer’s Drug Trials During a Pandemic: The EU/US CTAD Task Force

et al. 2021

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The 2020 COVID-19 pandemic has disrupted Alzheimer’s disease (AD) clinical studies worldwide. Digital technologies may help minimize disruptions by enabling remote assessment of subtle cognitive and functional changes over the course of the disease. The EU/US Clinical Trials in Alzheimer’s Disease (CTAD) Task Force met virtually in November 2020 to explore the opportunities and challenges associated with the use of digital technologies in AD clinical research. While recognizing the potential of digital tools to accelerate clinical trials, improve the engagement of diverse populations, capture clinically meaningful data, and lower costs, questions remain regarding the stability, validity, generalizability, and reproducibility of digital data. Substantial concerns also exist regarding regulatory acceptance and privacy. Nonetheless, the Task Force supported further exploration of digital technologies through collaboration and data sharing, noting the need for standardization of digital readouts. They also concluded that while it may be premature to employ remote assessments for trials of novel experimental medications, remote studies of non-invasive, multi-domain approaches may be feasible at this time.

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Toulouse Alzheimer’s Clinical Research Center Recovery After the Covid-19 Crisis: Telemedicine an Innovative Solution for Clinical Research During the Coronavirus Pandemic

Cited by 11 publications

References 8 publications

Transition from physical to virtual visit format for a longitudinal brain aging study, in response to the Covid‐19 pandemic. Operationalizing adaptive methods and challenges

Transition from physical to virtual visit format for a longitudinal brain aging study, in response to the Covid‐19 pandemic. Operationalizing adaptive methods and challenges

Managing Clinical Trials for Alzheimer’s Disease During the COVID-19 Crisis: Experience at Fundació ACE in Barcelona, Spain

Using Digital Tools to Advance Alzheimer’s Drug Trials During a Pandemic: The EU/US CTAD Task Force

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