Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2021;8(4):513-519.
doi: 10.14283/jpad.2021.36.

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

J Kaye  1 , P Aisen, R Amariglio, R Au, C Ballard, M Carrillo, H Fillit, T Iwatsubo, G Jimenez-Maggiora, S Lovestone, F Natanegara, K Papp, M E Soto, M Weiner, B Vellas
Affiliations

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

J Kaye et al. J Prev Alzheimers Dis. 2021.

Abstract

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.

Keywords: Alzheimer’s disease; clinical outcomes; digital tools; remote assessments.

PubMed Disclaimer

Conflict of interest statement

The Task Force was partially funded by registration fees from industrial participants. These corporations placed no restrictions on this work. Dr. Kaye reports grants from Merck, Eisai, Genentech, and Abbvie; and serves on a Data Safety Monitoring Committee at Eli Lilly. Dr. Aisen reports grants from Janssen, Eli Lilly, Eisai, NIA, the Alzheimer’s Association, and FNIH; and consulting fees from Biogen, Roche, Merck, Abbvie, Lundbeck, Proclara, and Immunobrain Checkpoint. Dr. Amariglio declares there are no conflicts. Dr. Au is on the scientific advisory board of Signant Health and a consultant to Biogen. Dr. Ballard reports grants from Arcadia pharmaceutical company and Lundbeck; personal fees from Arcadia, Lundbeck, Roche, Otsuka, Novartis, Eli Lilly, Suven, Sunovion, ADDEX, and Exciva; personal fees and other from Synexus, Novo Nordisk; and consulting fees from Biogen. Dr. Carillo declares there are no conflicts. Dr. Fillit declares there are no conflicts. Dr. Iwatsubo declares there are no conflicts. Dr. Jimenez-Maggiora declares there are no conflicts. Dr. Lovestone is an employee of Janssen Medical Ltd and a co-founder of Akrivia Health Ltd . Dr. Natanegara is an employee of Eli Lilly and Company. Dr. Papp declares there are no conflicts. Dr. Soto declares payment as consultant or advisor from Avanir, Acadia. Dr. Weiner reports grants from Siemens, Biogen, and Johnson and Johnson, NIH, California Department of Health, University of Michigan, Hillblom Foundation, Alzheimer’s Association, State of California, Kevin and Connie Shanahan, GE, VUMc, American Catholic University, The Stroke Foundation, and the Veteran’s Administration; has served on advisory boards for Eli Lilly, Cerecin/Accera, Roche, Alzheon Inc., Merck Sharp and Dohme Corp, Nestle/Nestec; and has consulted with or acted as a speaker to Cerecin/Accera Inc., BioClinica, Nestle/Nestec, Genentech, FUJIFILM-Toyama Chemical, and T3D Therapeutics; and holds stock options with Alzheon Inc, Alzeca, and Anven. Dr. Vellas reports grants from Lilly, Merck, Roche, Lundbeck, Biogen, grants from Alzheimer’s Association, European Commission, personal fees from Lilly, Merck, Roche, Biogen, outside the submitted work.

Figures

Figure 1
Figure 1
Pervasive Computing and Continuous Monitoring Demonstrate Effects of COVID-19 Pandemic on Loneliness and Physical Activity
See this image and copyright information in PMC

References

    1. Morris MC, Tangney CC, Wang Y, et al. MIND diet slows cognitive decline 1. van Dorn A. COVID-19 and readjusting clinical trials. The Lancet. 2020;396(10250):523–524. 10.1016/S0140-6736(20)31787-6 Aug 22. - DOI - PMC - PubMed
    1. Fleming TR, Labriola D, Wittes J. Conducting Clinical Research During the COVID-19 Pandemic: Protecting Scientific Integrity. JAMA. 2020;324(1):33–34. 10.1001/jama.2020.9286 Jul 7. - DOI - PubMed
    1. Sathian B, Asim M, Banerjee I, Pizarro AB, Roy B, van Teijlingen ER, et al. Impact of COVID-19 on clinical trials and clinical research: A systematic review. Nepal J Epidemiol. 2020;10(3):878–887. 10.3126/nje.v10i3.31622 Sep. - DOI - PMC - PubMed
    1. Brown EE, Kumar S, Rajji TK, Pollock BG, Mulsant BH. Anticipating and Mitigating the Impact of the COVID-19 Pandemic on Alzheimer's Disease and Related Dementias. Am J Geriatr Psychiatry. 2020;28(7):712–721. 10.1016/j.jagp.2020.04.010 Jul. - DOI - PMC - PubMed
    1. Food and Drug Administration . U.S. Department of Health and Human Services; 2020. Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency Guidance for Industry, Investigators, and Institutional Review Boards.