Measurement of Vigilance and CNS performance

Usefulness of the methods

Many drugs interfere with the ability of driving vehicles or handling dangerous machinery by influencing vigilance and CNS performance. Such effects have become an important safety issue in the drug approval process. This concerns drugs which intentionally act on the CNS (e.g. antiepileptics, antidepressants or anxiolytics) and others which may influence vigilance and CNS performance as an undesired effect ( e. g. NSAIDs or antihistamines ). Given that newer representatives of such drug groups are less prone to decrease vigilance and CNS-performance or may even be able to improve these functions (as shown by us for some examples of serotonin reuptake inhibitors), proving this may be of scientific, therapeutic and commercial importance. This is also a relevant aspect for hypnotics and sleep inducers which should be free of a hang over effect on vigilance and performance after an adequate time of sleep.

Principle of the methods

As vigilance and CNS performance are complex functions of the CNS we have compiled for their measurement a set of suitable multidimensional methods. These aim at measuring intellectual functions, cognitive functions, memory, eye-hand co-ordination, psychomotor functions in general and specific and non-specific vigilance. The methods are listed and described in the following of this page.

Advantages of the methods

False positive or negative results which could hamper further clinical development or broad clinical use of a new compound, are optimally excluded by the following features of our test battery:

• Reproducibility of the methods allowing for cross over designs. Every volunteer serves as his own control.
• Low inherent variation of the methods and reliability of their on-line evaluation.
• Due to the variety of methods employed each method is controlled by the other methods.
• Low inter-individual variation due to homo- geneity of our selected volunteer groups.
  

Reference data

Data are available for benzodiazepine and non-benzodiazepine anxiolytics, benzo-hypnotics, antidepressants, encephalotropics, antihistamines, analgesics, muscle relaxants, alcohol, stimulants, antitussives as well as for cardiovascular agents and anti-asthmatics.

Options

• Exclusion/ proof of hang-over effects on vigilance and CNS performance of drugs in the early stages of development
• Comparison of drugs with regard to their influence on specific and non-specific vigilance as well as CNS-performance
• Exclusion/ proof of a hang-over effect on vigilance and CNS performance of hypnotics and sleep inducers
• Concomitant pharmacokinetics