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Outline for the evaluation of nootropic drugs

  • Chapter
Alzheimer’s Disease. Epidemiology, Neuropathology, Neurochemistry, and Clinics

Part of the book series: Key Topics in Brain Research ((KEYTOPICS))

Abstract

In the course of the discussion concerning proof of the clinical relevance of nootropic effects, which was started in 1975 by Kanowski, the following items have been generally adopted as a basis for agreement on the performance of clinical studies for evaluating the efficacy of nootropics:

  1. a)

    Selection of the trial parameters and thus of the target criteria is to take place as directed by theory. Among other factors, as a prerequirement for this, only those areas of function can be taken into account as target criteria for which a change correlated with modifications in cerebral performance and/or syndromal modifications have been demonstrated in these fields.

  2. b)

    Confirmatory analysis of data presupposes an a priori definition of the target criteria and the methods of statistical inference.

  3. c)

    Evaluating the effect of the test substance is to be carried out on different planes which are independent of each other (e.g. physician, patient, nursing staff or objective test procedures, subjective assessment by third parties and everyday behaviour).

  4. d)

    Complex target criteria (such as e.g. objective test procedures) are to be examined as regards the importance of therapy-induced changes for the everyday behaviour of the patient and his subjective state, that is: they are to be validated.

  5. e)

    The measurement methods to be applied must meet the generally valid theoretical test requirements as to objectivity, reliability, validity and dimensionality, and be standardized or be in accordance with norms in the context of the age group to which a sample set of patients belongs.

  6. f)

    Where findings are to be evaluated parametrically, the effects ought to involve approximately half of a standard deviation in order to be clinically relevant.

  7. g)

    Non-parametric evaluation of the findings (e.g. in the form of the number of patients plus relevant effects) is less subject to influence through extreme values and, at the same time, makes easier recognition of the effects possible for the sample (of patients) examined.

  8. h)

    Taking into account that in multicentre studies the drug effect may be conceiled or accentuated by differences in therapeutic settings, long duration of the study, social structures, meteorological influences, dietary habits etc. etc. a comparable specific effect being documented in all or at least a majority of the study centres involved would doubtlessly be accepted as an indicator for therapeutical efficacy of the drug.

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Authors and Affiliations

  1. Hirnliga Heidelberg, Federal Republic of Germany

    Prof. Dr. S. Kanowski, G. Ladurner, K. Maurer, W. D. Oswald & U. Stein

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  1. Prof. Dr. S. Kanowski
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  2. G. Ladurner
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  3. K. Maurer
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  4. W. D. Oswald
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  5. U. Stein
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Editors and Affiliations

  1. Department of Psychiatry, University of Würzburg, Würzburg, Federal Republic of Germany

    Konrad Maurer , Peter Riederer  & Helmut Beckmann ,  & 

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Kanowski, S., Ladurner, G., Maurer, K., Oswald, W.D., Stein, U. (1990). Outline for the evaluation of nootropic drugs. In: Maurer, K., Riederer, P., Beckmann, H. (eds) Alzheimer’s Disease. Epidemiology, Neuropathology, Neurochemistry, and Clinics. Key Topics in Brain Research. Springer, Vienna. https://doi.org/10.1007/978-3-7091-3396-5_61

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  • DOI: https://doi.org/10.1007/978-3-7091-3396-5_61

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