Decentralized clinical trials for medications to reduce the risk of dementia: Consensus report and guidance

被引：2

作者：

Howard, Leanne ^{[1
,2
]}

Abdelnour, Carla ^{[3
]}

Abner, Erin L. ^{[4
]}

Allegri, Ricardo F. ^{[5
,6
]}

Dodge, Hiroko H. ^{[7
,8
]}

Gauthier, Serge ^{[9
]}

Hoyos, Camilla M. ^{[10
]}

Jicha, Gregory A. ^{[4
]}

Kehoe, Patrick G. ^{[11
]}

Mummery, Catherine J. ^{[12
]}

Ogunniyi, Adesola ^{[13
]}

Scarmeas, Nikolaos ^{[14
,15
]}

Chen, Xiaoying ^{[1
,2
]}

Titiner, Jodie R. ^{[16
]}

Weber, Christopher R. ^{[16
]}

Peters, Ruth ^{[1
,2
,17
]}

机构：

[1] George Inst Global Hlth, Brain Hlth, Sydney, NSW, Australia

[2] Univ New South Wales, Sch Populat Hlth, Sydney, NSW, Australia

[3] Stanford Univ, Sch Med, Dept Neurol & Neurol Sci, Stanford, CA USA

[4] Univ Kentucky, Dept Epidemiol & Environm Hlth, Lexington, KY USA

[5] Inst Invest Neurol Fleni, Dept Cognit Neurol Neuropsychol & Neuropsychiat, Buenos Aires, DF, Argentina

[6] Univ Costa, Dept Neurosci, Barranquilla, Colombia

[7] Massachusetts Gen Hosp, Dept Neurol, Boston, MA USA

[8] Harvard Med Sch, Boston, MA USA

[9] McGill Univ, Dept Neurol & Neurosurg, Montreal, PQ, Canada

[10] Macquarie Univ, Med Human & Hlth Sci, Sydney, NSW, Australia

[11] Univ Bristol, Translat Hlth Sci, Bristol Med Sch, Bristol, Avon, England

[12] UCL, Neurodegenerat Dis, London, England

[13] Univ Ibadan, Dept Med, Ibadan, Nigeria

[14] Natl & Kapodistrian Univ Athens, Aiginit Hosp, Med Sch, Dept Neurol 1, Athens, Greece

[15] Columbia Univ, Dept Neurol, New York, NY USA

[16] Alzheimers Assoc, Int Soc Adv Alzheimers Res & Treatment, Chicago, IL USA

[17] Imperial Coll London, Sch Publ Hlth, London, England

来源：

ALZHEIMERS & DEMENTIA | 2024年 / 20卷 / 07期

关键词：

decentralized clinical trials; Delphi process; dementia prevention; recommendations; remote clinical trials;

D O I：

10.1002/alz.13891

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

INTRODUCTIONRecent growth in the functionality and use of technology has prompted an increased interest in the potential for remote or decentralized clinical trials in dementia. There are many potential benefits associated with decentralized medication trials, but we currently lack specific recommendations for their delivery in the dementia field.METHODSA modified Delphi method engaged an expert panel to develop recommendations for the conduct of decentralized medication trials in dementia prevention. A working group of researchers and clinicians with expertise in dementia trials further refined the recommendations.RESULTSOverall, the recommendations support the delivery of decentralized trials in dementia prevention provided adequate safety checks and balances are included. A total of 40 recommendations are presented, spanning aspects of decentralized clinical trials, including safety, dispensing, outcome assessment, and data collection.DISCUSSIONThese recommendations provide an accessible, pragmatic guide for the design and conduct of remote medication trials for dementia prevention.Highlights Clinical trials of medication have begun adopting decentralized approaches. Researchers in the field lack guidance on what would be appropriate circumstances and frameworks for what would be appropriate circumstances and frameworks for the use of decentralized trial methods in dementia prevention. The present report provides consensus-based expert recommendations for decentralized clinical trials for dementia prevention.

引用

页码：4625 / 4634

页数：10

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