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. 2020;77(4):1805-1813.
doi: 10.3233/JAD-200750.

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

Carla Abdelnour  1   2 , Ester Esteban de Antonio  1 , Alba Pérez-Cordón  1 , Asunción Lafuente  1 , Mar Buendía  1 , Ana Pancho  1 , Sara Jofresa  1 , Nuria Aguilera  1 , Marta Ibarria  1 , Rosario Cuevas  1 , Laia Cañada  1 , Anna Calvet  1 , Susana Diego  1 , Antonio González-Pérez  1 , Adela Orellana  1   2 , Laura Montrreal  1 , Laura de Jorge  3 , Marta Marquié  1   2 , Alba Benaque  1 , Miren Gurruchaga  1 , Lluís Tárraga  1   2 , Agustín Ruiz  1   2 , Mercè Boada  1   2 ; Research Center and Memory Clinic, Fundació ACE
Collaborators, Affiliations

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

Carla Abdelnour et al. J Alzheimers Dis. 2020.

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.

Keywords: Alzheimer’s disease; clinical trials; coronavirus; pandemics; telemedicine.

PubMed Disclaimer

Conflict of interest statement

Authors’ disclosures available online (https://www.j-alz.com/manuscript-disclosures/20-0750r2).

Figures

Fig.1
Fig.1
Weekly calls and on-site visits immediately before and during the study period.
See this image and copyright information in PMC

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