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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

Abstract

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.

Keywords

Target Parameter Organic Brain Syndrome Affective Instability Global Deterioration Scale Nootropic Drug 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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References

  1. AGP. Arbeitsgemeinschaft für Gerontopsychiatrie. Ciompim L, Kanowski S (eds) (1982) Das AGP-System: Manual zur Dokumentation psychiatrischer Befunde bei Alterskranken. 2nd edn.Google Scholar
  2. American Psychiatric Association (1980) Diagnostic and statistical manual of mental disorders, 3rd edn. DSM-III. American Psychiatrie Association, Washington DCGoogle Scholar
  3. CIPS Collegium Internationale Psychiatriae Scalarum (ed) (1981) Internationale Skalen für Psychiatrie. Beltz, WeinheimGoogle Scholar
  4. Coper H, Kanowski S (1976) Geriatrika: Theoretische Grundlagen, Erwartung, Prüfung, Kritik. Hippokrates 47: 303–319Google Scholar
  5. Coper H, Kanowski S (1983) Nootropika: Grundlagen und Therapie. In: Langer G, Heimann H (eds) Psychopharmaka. Grundlagen und Therapie. Springer, Vienna New York, pp 409–430Google Scholar
  6. Committee for Geriatrie Diseases and Asthenias at BGA (1986) Impaired brain functions in old age. AMI-Heft 1, pp 1–264Google Scholar
  7. Erzigkeit H (1977) Der Syndrom-Kurztest zur Erfassung von Aufmerksamkeits- und Gedächtnisstörungen. VLESS, VaterstettenGoogle Scholar
  8. Gamzu ER (1987) Drug development of cognition activators — clinical aspects (Abstract no 356 and Referat). The third congress of the International Psychogeriatric Association (sponsored by the IPA in cooperation with Northwestern University Medical School), Chicago, 111. Aug 28–31Google Scholar
  9. Hachinski VC et al. (1975) Cerebral blood flow in dementia. Arch Neurol 32: 632–637PubMedCrossRefGoogle Scholar
  10. Herrmann WM, Kern U (1987) Multizentrische klinische Prüfungen — Möglichkeiten und Probleme. In: Coper H et al. (eds) Hirnorganische Psychosyndrome im Alter. III. Springer, Berlin Heidelberg New York, pp 80–108CrossRefGoogle Scholar
  11. Hoffmeister F, Benz U, Heise A, Krause HP, Neuser V (1982) Behavioral effects of nimodipine in animals. Arzneimittelforschung/Drug Res 32: 347–360Google Scholar
  12. Kahn RL, Pollack M, Goldfarb AI (1961) Factors related to individual differences in mental status of institutionalized aged. In: Hock PH, Zubin J (eds) Psychopathology of aging. Grune and Stratton, New York, pp 104–113Google Scholar
  13. Kanowski S (1975) Methodenkritische Überlegungen zur Prüfung von Geriatrika. Z. Gerontol 5: 316–322Google Scholar
  14. Kanowski S (1986) Möglichkeiten und Grenzen der Therapie mit Nootropika. Hospitalis 56:400–409Google Scholar
  15. Kanowski S (1987) Möglichkeiten eines modular aufgebauten Systems klinischer Prüfungen von Nootropika. In: Coper H et al. (eds) Hirnorganische Psychosyndrome im Alter. III. Springer, Berlin Heidelberg New York, pp 73–79CrossRefGoogle Scholar
  16. Kanowski S, Coper H (1982) Das hirnorganische Psychosyndrom als Ziel pharmakologischer Beeinflussung. In: Bente D, Coper H, Kanowski S (eds) Hirnorganische Psychosyndrome im Alter. II. Springer, Berlin Heidelberg New York, pp 3–19CrossRefGoogle Scholar
  17. Kanowski S, Hedde JP (1986) Arzneimittel für die Indikation hirnorganisch bedingter Leistungsstörungen (Nootropika). In: Dölle W, Müller-Oerlinghausen, Schwabe U (eds) Grundlagen der Arzneimitteltherapie. Bibliographisches Institut, Mannheim, pp 154–171Google Scholar
  18. McKhann G, Drachman D, Folstein M, Katzmann R, Price D, Stadlan EM (1984) Clinical diagnosis of Alzheimer’s disease: report of the NINCDS-ADRDA work group under the auspices of Department of Health and Human Services Task Force on Alzheimer’s disease. Neurology 34: 939–944.PubMedGoogle Scholar
  19. Oswald WD, Fleischmann UM (1986) Nürnberger-Alters-Inventar NAI. Published by author, ErlangenGoogle Scholar
  20. Reisberg B et al. (1982) The Global Deterioration Scale (GDS): an instrument for the assessment in Primary Degenerative Dementia (PDD). Am J Psychiatry 139: 1136–1139PubMedGoogle Scholar
  21. Sonnemann E (1984) Allgemeine Lösungen multipler Testprobleme EDV in Medizin u. Biologie. Internationale Biometrische Gesellschaft (ed) Vol 13, pp 120–128Google Scholar
  22. Winblad B (1987) Alzheimer’s disease — a Nordic perspective (Referat). The Third Congress of the International Psychogeriatric Association (sponsored by the IPA in cooperation with Northwestern University Medical School), Chicago, 111. Aug 28–31Google Scholar

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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