STUDIES OF AGITATION / AGGRESSION IN ALZHEIMER’S DISEASE – SCIENTIFIC AND OPERATIONAL CHALLENGES
K. Siegfried, V. Legrand
J Prev Alz Dis 2015;2(3):157-159
The paper addresses important questions and challenges of protocol features and conditions of efficacy and safety studies of agitation / aggression in patients with Alzheimer’s Disease (AD). Specifically, questions of patient selection criteria, study settings (outpatient, nursing home studies) and study design features are discussed. The comments and advices provided were based on inquiries conducted with an international group of 24 clinical experts in AD (from Asia, Europe, Latin America and the US). There was a good agreement on study duration and the basic study design features, whereas different views were expressed on the types of allowable concomitant medication and (partially also) on study settings. Decisions on most of these protocol features will have major operational consequences (e.g. on recruitment rates, recruitment strategies) which need to be considered in a reasonable trade-off with methodological requirements to make the study feasible and at the same time ensure the highest scientific standards possible.
K. Siegfried ; V. Legrand ; (2015): Studies of Agitation / Aggression in Alzheimer’s Disease – Scientific and Operational Challenges. The Journal of Prevention of Alzheimer’s Disease (JPAD). http://dx.doi.org/10.14283/jpad.2015.51