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FDA Recognition of Clinical Spectrum in the Dementias

Regulatory Issues in the Development of Drug Treatments for Various Psychiatric and Behavioral Disturbances Associated with Dementia Thomas Laughren, M.D. Team Leader, Psychiatric Drug Products Group Division of Neuropharmacological Drug Products FDA.

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FDA Recognition of Clinical Spectrum in the Dementias

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  1. Regulatory Issues in the Development of Drug Treatments for Various Psychiatric and Behavioral Disturbances Associated with DementiaThomas Laughren, M.D.Team Leader, Psychiatric Drug Products GroupDivision of Neuropharmacological Drug ProductsFDA

  2. FDA Recognition of Clinical Spectrum in the Dementias • Increasing prevalence of dementias • Clinical Spectrum • -Cognitive impairment • -Psychiatric/behavioral disturbances • -Both aspects represent burden • -Drug Development • -Emphasis on cognitive impairment • -Psychiatric/behavioral disturbances important target

  3. BPSD as Useful Concept • Focuses attention on this important aspect of dementia • Identifies dementia as population with (possibly) unique psychiatric disturbances -These remain to be defined

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