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Study Design in Dementia Drug Trials

Published online by Cambridge University Press:  02 December 2014

Chris MacKnight
Chris MacKnight*
Affiliation:
The Division of Geriatric Medicine, Dalhousie University, Halifax, NS, Canada
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Abstract

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A great deal of progress has been made in the management of Alzheimer's disease and other dementias over the past 25 years. Much remains to be achieved, however. This article discusses some of the issues surrounding study design. In the absence of an accepted biological marker of progression, it is unlikely that a novel study design, such as randomized start or withdrawal, in itself could provide convincing evidence of disease modification. Biological markers will also be crucial in the development of therapies aimed at specific processes, and of immunotherapies.

Résumé

RÉSUMÉ

Le traitement de la maladie d’Alzheimer et des autres démences s’est beaucoup amélioré depuis 25 ans. Cependant, il reste beaucoup à faire. Cet article discute des problèmes relatifs au plan d’étude. Comme il n’existe pas de marqueur biologique accepté pour évaluer la progression de la maladie il est peu probable qu’un plan d’étude novateur tel un début randomisé ou un retrait de la médication anti-démence pourra fournir des données convaincantes que l’évolution de la maladie a été modifiée. Des marqueurs biologiques seront également cruciaux pour le développement de traitements ciblant des processus spécifiques et pour le développement d’immunothérapies.

Type
Original Articles
Information
Canadian Journal of Neurological Sciences , Volume 34 , Issue S1 , March 2007 , pp. S19 - S22
Copyright
Copyright © The Canadian Journal of Neurological 2007

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