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

Abstract

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.

Dementia wellbeing and COVID‐19: Review and expert consensus on current research and knowledge gaps

“…Four centres 80 , 82 , 85 , 83 published their experiences of the impact of the pandemic on clinical research activities. There was a reduction in patient recruitment and in‐person visits, but participation rates in ongoing studies remained high.…”

Effects of COVID-19 on preclinical and clinical research in neurology: Examples from research on neurodegeneration and Alzheimer’s disease

“…Prolonged site closures could also affect participant retention, but, encouragingly, this was not an issue at the Knight ADRC CTU, where we had no attrition of clinical trial participants because of COVID. Other trial sites reported similarly low rates of attrition, such as the Fundacio ACE in Barcelona, where only one partic-ipant out of 108 randomized patients left a clinical trial study during the COVID-19 pandemic (Abdelnour et al, 2020). Anecdotally, we found that participants with symptomatic AD and their caregivers believed they received benefit from participating in blinded randomized trials.…”

“…We ultimately stopped all in-person visits and had clinical trial staff work from home beginning April 7, 2020, as COVID-19 numbers increased and university guidelines evolved. As at other sites, trial coordinators remained in contact with participants through phone calls, conducting safety assessments and promoting participant engagement (Abdelnour et al, 2020). Clinical trial staff had added administrative burdens during this time, for example, spending time locating and then setting up alternative imaging facilities, working to orient and supervise home health nurses (HHNs), and preparing for remote rather than in-person monitoring.…”

“…For most studies, there was less flexibility around outcome measures, with most cognitive and clinical measures remaining in person. Because many study interventions are monthly, the number of missed doses may be relatively low at sites that were able to resume study visits within a few months (Abdelnour et al, 2020). The impact will be more substantial when study drug administration is more common (e.g., biweekly) or when sites suspend visits for many months or even years.…”

The role of sex and gender in the selection of Alzheimer patients for clinical trial pre-screening

“…Another interesting point for further study is the potential effects on the gender gap of the application of digital technologies in dementia trials. The COVID-19 pandemic has led to the adaption to a model of care based on digital technologies that will continue into the recovery [ 44 , 45 ]. The use of telemedicine or the application of digitized (at-home) cognitive tests are current technological developments that can benefit the participation of women in trials, as they will avoid recurrent visits to the clinic and thus facilitate family conciliation.…”