Decentralised clinical trials for medications to reduce the risk of dementia: consensus report and guidance

Leanne Howard, Carla Abdelnour, Erin L Abner, Ricardo Allegri, Hiroko H Dodge, Serge Gauthier, Camilla M Hoyos, Gregory A Jicha, Patrick Gavin Kehoe, Catherine J Mummery, Adesola Ogunniyi, Nikolaos Scarmeas, Xiaoying Chen, Jodi R Titiner, Christopher J Weber, Ruth Peters*, The Clinical Trial, Methodology Professional Interest Area Remote Trial Working Group

*Corresponding author for this work

Research output: Contribution to conferenceConference Posterpeer-review

Abstract

Background
Recent growth in the functionality and use of technology has prompted an increased interest in the potential for remote or decentralised clinical trials in dementia. There are many potential benefits associated with decentralised medication trials, but the field is currently lacking specific recommendations for their delivery in the dementia field.

Method
A modified Delphi method engaged a panel with substantial expertise in dementia trial design and delivery and backgrounds that included neurology, psychiatry, pharmacology and psychology, to develop recommendations for the conduct of decentralised medication trials in dementia prevention. A working group of researchers and clinicians with expertise in dementia trials further refined the recommendations.

Result
Overall, the recommendations support the delivery of decentralised remote trials in dementia prevention provided adequate safety checks and balances are included. A total of 40 recommendations will be presented, spanning aspects of decentralised clinical trials dementia prevention trials in phases 2b-4, including safety, dispensing, outcome assessment, and data collection.

Conclusion
With these recommendations we provide an accessible, pragmatic guide for the design and conduct of remote medication trials for the prevention of dementia.
Original languageEnglish
Pagese085781
Number of pages1
DOIs
Publication statusPublished - 9 Jan 2025
EventAAIC 2024: Alzheimer’s Association International Conference 2024 - Philadelphia, United States
Duration: 28 Jul 20241 Aug 2024
https://aaic.alz.org/highlights2024.asp

Conference

ConferenceAAIC 2024: Alzheimer’s Association International Conference 2024
Country/TerritoryUnited States
CityPhiladelphia
Period28/07/241/08/24
Internet address

Bibliographical note

© 2024 The Alzheimer's Association. Alzheimer's & Dementia published by Wiley Periodicals LLC on behalf of Alzheimer's Association.

Keywords

  • Humans
  • Dementia/prevention & control
  • Drug Development
  • Clinical Trials as Topic
  • Delphi Technique
  • Research Design

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