title: Galantamine treatment of problematic behavior in Alzheimer disease: post-hoc analysis of pooled data from three large trials.
abstract: OBJECTIVE
  The authors explored the effect of galantamine on behavioral symptoms in Alzheimer disease (AD).
  
  
  METHODS
  Data were pooled from 2,033 subjects with mild-to-moderate AD who had participated in one of three randomized, double-blind, placebo-controlled trials of 3-, 5-, and 6-month durations. Subjects included in this post hoc analysis had received treatment with either placebo (N=686) or galantamine (N=1347) in total daily doses of 16 mg, 24 mg, or 32 mg. Behavioral symptoms were measured on the 10-item Neuropsychiatric Inventory (NPI). Four symptom clusters were defined a priori: 1) delusions, hallucinations; 2) agitation, depression, anxiety, apathy, irritability; 3) disinhibition, elation, aberrant motor behavior; 4) hallucinations, anxiety, apathy, aberrant motor behavior.
  
  
  RESULTS
  At endpoint, mean changes from baseline in NPI scores were significantly different between galantamine-treated subjects and placebo-treated subjects, favoring galantamine for several measures: total NPI, individual domains of agitation/aggression, anxiety, disinhibition, and aberrant motor behavior, and Clusters 1, 3, and 4. The magnitude of the effect sizes was small.
  
  
  CONCLUSIONS
  In this pooled sample of more than 2,000 subjects with mild-to-moderate AD, those who received galantamine therapy experienced modestly better, but statistically significant, outcomes in their behavioral symptoms than placebo-treated subjects. The cluster of hallucinations, anxiety, apathy and aberrant motor behaviors may represent a specific group of cholinergic-responsive behavioral symptoms.
authors.affiliation: Dept. of Psychiatry, Sunnybrook and Women's College Health Sciences Centre, Toronto, Ontario, CANADA, M4N 3M5. Nathan.Herrmann@sw.ca
authors.forename: Nathan
authors.initials: N
authors.lastname: Herrmann
authors.forename: Kiran
authors.initials: K
authors.lastname: Rabheru
authors.forename: Jenny
authors.initials: J
authors.lastname: Wang
authors.forename: Carin
authors.initials: C
authors.lastname: Binder
mesh_terms: D000368:Aged; D000544:Alzheimer Disease / Q000523:psychology*; D002800:Cholinesterase Inhibitors / Q000627:therapeutic use*; D003702:Delusions / Q000188:drug therapy* / Q000209:etiology*; D004311:Double-Blind Method; D005260:Female; D005702:Galantamine / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D001523:Mental Disorders / Q000188:drug therapy* / Q000209:etiology*; D011595:Psychomotor Agitation / Q000188:drug therapy* / Q000209:etiology*; D016896:Treatment Outcome
chemical_list: D002800:Cholinesterase Inhibitors; D005702:Galantamine