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IDENTIFYING BETTER OUTCOME MEASURES TO IMPROVE TREATMENT OF AGITATION IN DEMENTIA: A REPORT FROM THE EU/US/CTAD TASK FORCE

Agitation and other neuropsychiatric symptoms (NPS) are the most disruptive aspects of dementia for both patients and caregivers. They are associated with worse quality of life, greater dementia severity, earlier institutionalization, and accelerated mortality . Despite being a major driver of high cost care , agitation and other NPS are poorly understood and inadequately studied. In a population-based study, agitation in dementia occurred in up to 40% of community-dwelling dementia patients and 80% of patients living in nursing homes. Cross-sectional studies show somewhat lower prevalence estimates. For persons with mild cognitive impairment (MCI) the prevalence of agitation is nearly as high, according to some studies. There are no approved pharmacological treatments for agitation in dementia in the USA and in Europe and Canada only short-term use of risperidone is approved for severe persistent physical aggression. Several medications with conventional and novel mechanisms of action are in development.
For the second time in the past 3 years, the EU-US CTAD Task Force addressed challenges related to designing clinical trials for agitation in dementia, which is one of the most disruptive aspects of the condition for both patients and caregivers (Sano M et al (J Prev Alz Dis 2018;5(2):98-102). Six recommendations emerged from the Task Force meeting: 1 – Operationalizing agitation criteria established by the IPA; 2 – Combining clinician- and caregiver-derived outcomes as primary outcome measures; 3 – Using global ratings to define clinically  meaningful effects and power studies; 4 – Improving the accuracy of caregiver reports by better training and education of caregivers; 5 – Employing emerging technologies to collect near real-time behavioral data; and 6 – Utilizing innovative trial designs and increasing the use of biomarkers to maximize the productivity of clinical trials for neuropsychiatric symptoms.

M. Sano ; M. Soto ; M. Carrillo ; J. Cummings ; S. Hendrix ; J. Mintzer ; A. Porsteinsson ; P. Rosenberg ; L. Schneider ; J. Touchon ; P. Aisen ; B. Vellas ; C. Lyketsos ; and the EU/US/CTAD Task Force members: Identifying Better Outcome Measures to Improve Treatment of Agitation in Dementia: A Report from the EU/US/CTAD Task Force. J Prev Alz Dis 2018;5(2):98-102. http://dx.doi.org/10.14283/jpad.2018.15