title: Effects of memantine on behavioural symptoms in Alzheimer's disease patients: an analysis of the Neuropsychiatric Inventory (NPI) data of two randomised, controlled studies.
abstract: BACKGROUND
  Behavioural symptoms are common in moderate to severe Alzheimer's disease (AD). We have analysed the databases of two randomised studies with regard to the effects of memantine treatment on behavioural symptoms, measured using the 12-item version of the Neuropsychiatric Inventory (NPI).
  
  
  METHODS
  The monotherapy study (memantine only) reported by Reisberg et al. (2003) involved 252 patients with baseline MMSE total score of between 3 and 14, whereas the combination study (memantine and donepezil) reported by Tariot et al. (2004) comprised 404 patients with MMSE scores of between 5 and 14. In both studies, patients received 10 mg memantine b.i.d. or matching placebo, and lived in the community.
  
  
  METHODS
  For both studies NPI total and individual domains scores were analysed in the ITT population. For the monotherapy study a dichotomised analysis was performed separately for patients who had behavioural symptoms at baseline and for those without pre-existing symptoms. Furthermore, a factor analysis was used to identify any behavioural clusters within the patient population.
  
  
  RESULTS
  In both studies, the change in NPI total scores at endpoint was consistently in favour of memantine treatment, reaching statistical significance in the combination study (p = 0.002). Memantine treatment showed a significant beneficial effect in comparison to placebo treatment in the NPI agitation/aggression domain in both studies (p = 0.008; p = 0.001). The dichotomised analysis of the monotherapy study showed that there was significantly less agitation/aggression emerging in the memantine-treated group compared to placebo (p = 0.003). Factor analysis showed that hyperactivity accounted for 27% of the data variance.
  
  
  CONCLUSIONS
  Memantine has a beneficial effect on the behavioural symptoms of patients with moderate to severe AD, with the most pronounced effect on agitation/aggression.
authors.affiliation: MCSA Alzheimer's Disease Research Unit, McGill Centre for Studies in Aging, Quebec, Canada. serge.gauthier@mcgill.ca
authors.forename: S
authors.initials: S
authors.lastname: Gauthier
authors.forename: Y
authors.initials: Y
authors.lastname: Wirth
authors.forename: H J
authors.initials: HJ
authors.lastname: Möbius
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000188:drug therapy* / Q000523:psychology; D001526:Behavioral Symptoms / Q000188:drug therapy*; D004311:Double-Blind Method; D018691:Excitatory Amino Acid Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D005163:Factor Analysis, Statistical; D005260:Female; D006801:Humans; D008297:Male; D008559:Memantine / Q000009:adverse effects / Q000627:therapeutic use*; D009483:Neuropsychological Tests; D016032:Randomized Controlled Trials as Topic
chemical_list: D018691:Excitatory Amino Acid Antagonists; D008559:Memantine