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Soto M, Abushakra S, Cummings J, et al. Progress in Treatment Development for Neuropsychiatric Symptoms in Alzheimer's Disease: Focus on Agitation and Aggression. A Report from the EU/US/CTAD Task Force. J Prev Alzheimers Dis. 2015;2(3):184-188doi: 10.14283/jpad.2015.77.
Soto, M., Abushakra, S., Cummings, J., Siffert, J., Robert, P., Vellas, B., Lyketsos, C. G. (2015). Progress in Treatment Development for Neuropsychiatric Symptoms in Alzheimer's Disease: Focus on Agitation and Aggression. A Report from the EU/US/CTAD Task Force. The journal of prevention of Alzheimer's disease, 2(3), 184-188. https://doi.org/10.14283/jpad.2015.77
Soto, M, et al. "Progress in Treatment Development for Neuropsychiatric Symptoms in Alzheimer's Disease: Focus on Agitation and Aggression. A Report from the EU/US/CTAD Task Force." The journal of prevention of Alzheimer's disease vol. 2,3 (2015): 184-188. doi: https://doi.org/10.14283/jpad.2015.77
Soto M, Abushakra S, Cummings J, Siffert J, Robert P, Vellas B, Lyketsos CG. Progress in Treatment Development for Neuropsychiatric Symptoms in Alzheimer's Disease: Focus on Agitation and Aggression. A Report from the EU/US/CTAD Task Force. J Prev Alzheimers Dis. 2015 Sep;2(3):184-188. doi: 10.14283/jpad.2015.77. PMID: 26413494; PMCID: PMC4580980.
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J Prev Alzheimers Dis. 2015 Sep;2(3):184-188. doi: 10.14283/jpad.2015.77.

Progress in Treatment Development for Neuropsychiatric Symptoms in Alzheimer's Disease: Focus on Agitation and Aggression. A Report from the EU/US/CTAD Task Force.

The journal of prevention of Alzheimer's disease

M Soto, S Abushakra, J Cummings, J Siffert, P Robert, B Vellas, C G Lyketsos,

Affiliations

  1. Gerontopole, INSERM U1027, Alzheimer's Disease Research and Clinical Center, Toulouse University Hospital, Toulouse, France.
  2. Transition Therapeutics, San Matteo, California, USA.
  3. Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas, USA.
  4. Avanir Pharmaceuticals, Inc. Aliso Viejo, USA.
  5. EA CoBTeK/ICMRR University of Nice Sophia Antipolis - CHU, France.
  6. Department of Psychiatry, The Johns Hopkins Bayview Medical Center, Baltimore, MD, USA.

PMID: 26413494 PMCID: PMC4580980 DOI: 10.14283/jpad.2015.77

Abstract

The management of neuropsychiatric symptoms (NPS) such as agitation and aggression is a major priority in caring for people with Alzheimer's disease (AD). Agitation and aggression (A/A) are among the most disruptive symptoms, and given their impact, they are increasingly an important target for development of effective treatments. Considerable progress has been made in the last years with a growing number of randomized controlled trials (RCTs) of drugs for NPS. The limited benefits reported in some RCTs may be accounted for by the absence of a biological link of the tested molecule to NPS and also by key methodological issues. In recent RCTs of A/A, a great heterogeneity design was found. Designing trials for dementia populations with NPS presents many challenges, including identification of appropriate participants for such trials, engagement and compliance of patients and caregivers in the trials and the choice of optimal outcome measures to demonstrate treatment effectiveness. The EU/US -CTAD Task Force, an international collaboration of investigators from academia, industry, non-profit foundations, and regulatory agencies met in Philadelphia on November 19, 2014 to address some of these challenges. Despite potential heterogeneity in clinical manifestations and neurobiology, agitation and aggression seems to be accepted as an entity for drug development. The field appears to be reaching a consensus in using both agitation and aggression (or other NPS)-specific quantitative measures plus a global rating of change for agitation outcomes based on clinician judgment as the main outcomes.

Keywords: Alzheimer’s; Behavior; aggression; agitation; clinical trial; measurement; therapeutics

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