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Alzheimer's & Dementia logoLink to Alzheimer's & Dementia
. 2025 Jan 9;20(Suppl 6):e085781. doi: 10.1002/alz.085781

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

Leanne Howard 1, Carla Abdelnour 2, Erin L Abner 3, Ricardo Allegri 4, Hiroko H Dodge 5, Serge Gauthier 6, Camilla M Hoyos 7, Gregory A Jicha 8, Patrick Gavin Kehoe 9, Catherine J Mummery 10, Adesola Ogunniyi 11, Nikolaos Scarmeas 12,13, Xiaoying Chen 1, Jodi R Titiner 14, Christopher J Weber 15, Ruth Peters 1,16,, The Clinical Trial 1, Methodology Professional Interest Area Remote Trial Working Group 1
PMCID: PMC11713897

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.


Articles from Alzheimer's & Dementia are provided here courtesy of Wiley

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