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Memantine effects measured with the Relevant Outcome Scale for Alzheimer's disease in an open-label, single-arm, multicenter clinical study

Authors

  • Vjera Holthoff,

    1. DZNE, German Center for Neurodegenerative Diseases, Dresden, and University Hospital Carl Gustav Carus, University of Technology, Dresden, Germany
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  • Steven Ferris,

    1. Alzheimer's Disease Center, New York University Langone Medical Center, New York, USA
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  • Serge Gauthier,

    1. McGill Centre for Studies in Aging, Verdun, Quebec, Canada
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  • Ralf Ihl,

    1. Clinic of Geriatric Psychiatry and Psychotherapy, Alexian Krefeld GmbH, Krefeld, Germany
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  • Philippe Robert,

    1. Memory Center, EA CoBTek, Université de Nice Sophia Antipolis, Nice, France
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  • Bengt Winblad,

    1. Alzheimer Disease Research Center, Karolinska Institutet, Stockholm, Sweden
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  • Kati Sternberg,

    1. Merz Pharmaceuticals GmbH, Frankfurt, Germany
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  • Frank Tennigkeit,

    1. AC Immune SA, Lausanne, Switzerland
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  • The ROSA Study Group

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    • Members of the Rosa Study Group

      Germany: Heike Agne, Walter Albrecht, Gerd Benesch, Arnfin Bergmann, Katharina Bürger/Rujescu, Barbara Florange, Helmut Frohnhofen, Renate Frühauf, Gerhard Fuß, Jürgen Gebauer, Hans Gutzmann, Klaus Hager, Gabriele Heidenreich, Hans-Georg Heinemann, Heinrich Henin, Heinz Herbst, Vjera Holthoff, Andreas Hufnagel, Judith Jeske, Hans-H. Klünemann, Frank Kühn, Michaela Krause, Harald-Christian Landefeld, Ann-Kathrin Meyer, Tomas Müller-Thomsen, Christian Neudert, Albert Niederhofer, Klaus-Ulrich Oehler, Harm-Cornelis Overbeek, Andrej Pauls, Jörg Peltz, Gerd Reifschneider, Matthias W. Riepe, Gerhard Roth, Ulrich Schäfer, Eva Schielke, Erich Scholz, Frank Schwärzler, Karl-Otto Sigel, Rhena Sloksnat, Klaus Stecker, Bernd Straub, Paul P. Urban, Christine von Arnim, Markus Weih, Rainer Wolf, Elke Wollenhaupt, Hans-Peter Wunderlich, Anton Zellner; Austria: Christian Bancher, Bernhard Iglseder, Gunther Ladurner, Christian Lampl, Michael Rainer, Gerhard Ransmayer.


V. Holthoff, E-mail: Vjera.Holthoff@uniklinikum-dresden.de

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.

Conclusion

The results demonstrated the ROSA feasibility in daily practice for assessment of memantine effects over time in patients with moderate and late AD. Copyright © 2012 John Wiley & Sons, Ltd.

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