Therapeutic Efficacy of Nootropic Drugs — A Discussion of Clinical Phase III Studies with Nimodipine as a Model

  • S. Kanowski
  • P. Fischhof
  • R. Hiersemenzel
  • J. Röhmel
  • U. Kern


With regard to proving the clinical efficacy of nootropic substances there has been intense methodological discussion since 1975 (Kanowski 1975, 1986; Coper and Kanowski 1976, 1983; Kanowski and Hedde 1986; Comittee for Geriatric Diseases and Asthenias at BGA 1986). Both the selection of target parameters (outcome measures) and definition of diagnoses for inclusion are the subject of current debate, particularly given some of the differences in approach between research in the United States and that in Europe. In the United States, for instance, there has recently been a move to stop the use of traditional performance tests and symptom rating scales as therapeutic outcome measures and to adopt improvements within global clinical diagnostic rating scales instead, for example, a refinement to the Global Deterioration Scale (GDS; Reisberg 1982) as a target criterion (Gamzu 1987). It has been argued that an improvement from, say, GDS stage 4 (moderate impairment of cognitive function) to stage 3 (slight cognitive impairment) would certainly represent a change in elderly patients that is relevant to their daily lives.


Target Parameter Organic Brain Syndrome Affective Instability Global Deterioration Scale Nootropic Drug 
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Copyright information

© Springer-Verlag Berlin Heidelberg 1989

Authors and Affiliations

  • S. Kanowski
  • P. Fischhof
  • R. Hiersemenzel
  • J. Röhmel
  • U. Kern

There are no affiliations available

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