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Identifying Better Outcome Measures to Improve Treatment of Agitation in Dementia: A Report from the EU/US/CTAD Task Force

  • Mary 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
  • EU/US/CTAD Task Force members
CTAD Task Force Paper
  • 30 Downloads

Abstract

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. 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.

Key words

Neuropsychiatric symptoms agitation dementia Alzheimer’s disease clinical trials NPS outcome measures 

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Copyright information

© Serdi and Springer Nature Switzerland AG 2018

Authors and Affiliations

  • Mary Sano
    • 1
  • M. Soto
    • 2
  • M. Carrillo
    • 3
  • J. Cummings
    • 4
  • S. Hendrix
    • 5
  • J. Mintzer
    • 6
  • A. Porsteinsson
    • 7
  • P. Rosenberg
    • 8
  • L. Schneider
    • 9
  • J. Touchon
    • 10
    • 11
  • P. Aisen
    • 12
  • B. Vellas
    • 2
  • C. Lyketsos
    • 8
  • EU/US/CTAD Task Force members
  1. 1.Mount Sinai School of MedicineBronxUSA
  2. 2.Gerontopole, INSERM U1027, Alzheimer’s Disease Research and Clinical CenterToulouse University HospitalToulouseFrance
  3. 3.Alzheimer’s AssociationChicagoUSA
  4. 4.Cleveland Clinic Lou Ruvo Center for Brain HealthLas VegasUSA
  5. 5.Pentara CorporationSalt Lake CityUSA
  6. 6.Roper St. Francis CBRTCharlestonUSA
  7. 7.University of Rochester School of Medicine and DentistryRochesterUSA
  8. 8.Johns Hopkins University School of MedicineBaltimoreUSA
  9. 9.University of Southern CaliforniaLos AngelesUSA
  10. 10.University Hospital of MontpellierMontepellier Cedex 5France
  11. 11.INSERM 1061MontepellierFrance
  12. 12.Alzheimer’s Therapeutic Research Institute (ATRI), Keck School of MedicineUniversity of Southern CaliforniaSan DiegoUSA

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