title: Memantine effects measured with the Relevant Outcome Scale for Alzheimer's disease in an open-label, single-arm, multicenter clinical study.
abstract: OBJECTIVE
  The Relevant Outcome Scale for Alzheimer's disease (ROSA) is a novel, valid, and reliable instrument for multidimensional assessment of Alzheimer's disease (AD) symptoms across all severity stages. The ROSA and four standard instruments -- the Alzheimer's disease Assessment Scale-cognitive (ADAS-cog), Severe Impairment Battery (SIB), Disability Assessment for Dementia (DAD), and the Neuropsychiatric Inventory (NPI) -- were used in an open-label, multicenter, single-arm clinical study to assess treatment-induced changes in cognitive, functional, and behavioral symptoms in patients with AD at different severity stages.
  
  
  METHODS
  A total of 451 patients were treated with memantine (initiated at 5 mg/day and up-titrated with 5 mg weekly to a final dose of 20 mg/day) for 12 weeks. The study endpoints comprised changes from baseline in the scores of the ROSA, ADAS-cog, SIB, DAD, and NPI as well as global changes on the Clinical Global Impression of Change (CGI-C). Analyses were performed for the overall population and by AD severity stage (early, middle, late).
  
  
  RESULTS
  The ROSA scores increased significantly after a 12-week treatment in all study groups except for early stage. Mean changes in the ADAS-cog score indicated a trend towards worsening in early and middle stages. Non-significant changes were shown by the SIB, NPI, and DAD assessments at week 12. The CGI-C demonstrated 'minimal improvement' or 'no change' for most of the patients. Overall, memantine treatment was safe and well tolerated.
  
  
  CONCLUSIONS
  The results demonstrated the ROSA feasibility in daily practice for assessment of memantine effects over time in patients with moderate and late AD.
authors.affiliation: DZNE, German Center for Neurodegenerative Diseases, Dresden, and University Hospital Carl Gustav Carus, University of Technology, Dresden, Germany. Vjera.Holthoff@uniklinikum-dresden.de
authors.forename: Vjera
authors.initials: V
authors.lastname: Holthoff
authors.forename: Steven
authors.initials: S
authors.lastname: Ferris
authors.forename: Serge
authors.initials: S
authors.lastname: Gauthier
authors.forename: Ralf
authors.initials: R
authors.lastname: Ihl
authors.forename: Philippe
authors.initials: P
authors.lastname: Robert
authors.forename: Bengt
authors.initials: B
authors.lastname: Winblad
authors.forename: Kati
authors.initials: K
authors.lastname: Sternberg
authors.forename: Frank
authors.initials: F
authors.lastname: Tennigkeit
mesh_terms: D000203:Activities of Daily Living; D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000188:drug therapy*; D001317:Austria; D004185:Disability Evaluation; D005260:Female; D005858:Germany; D006801:Humans; D008297:Male; D008559:Memantine / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D018697:Nootropic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D017063:Outcome Assessment, Health Care / Q000379:methods; D011569:Psychiatric Status Rating Scales; D011788:Quality of Life
chemical_list: D018697:Nootropic Agents; D008559:Memantine