Discussion 7

Extract

A considerable portion of this discussion was devoted to whether symptoms such as depression, agitation, and psychosis are different in patients with dementia compared with those without dementia, and whether such symptoms warrant approval as new drug indications. Dr. Schneider noted that the U.S. Food and Drug Administration (FDA) recognizes depressive syndrome, psychosis, and mania within dementia, and will consider applications to add such indications to existing drug labeling. Dr. Whitehouse agreed that the FDA has been responsive to how the scientific community conceptualizes symptoms in dementia. The FDA has endorsed the notion of behavioral and psychological symptoms of dementia (BPSD) as an umbrella term, and also recognizes more specific target behavioral symptoms. Dr. McKeith believes that the target symptom approach would be accepted in Europe, although he was concerned about an excessive need for defining each symptom, which would unnecessarily prolong the review and approval process.