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| home > epc > summer 2002 > the assessment of human cognitive function in clinical trials |
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European Pharmaceutical Contractor
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The need for proper and comprehensive assessment of human cognitive function in the development of novel medicines is becoming widely recognised. One of the reasons for this is the fact that there are automated cognitive testing systems which have now been in use for 15 years or more, and which have large normative and drug databases. Such systems have greatly facilitated testing, improved quality and sensitivity, and enabled the identification of effects which previously went unnoticed with traditional techniques. Automated tests are now routinely applied in early drug development, and can identify both unwanted cognitive impairment (or its absence) as well as cognition enhancement.
Furthermore, many illnesses, both physical and mental, are associated with cognitive impairment, and many novel therapies for such treatments have the benefit of reversing some of these impairments, in part due to being free from cognition impairing effects themselves. Automated testing has helped to demonstrate that there are major deficits to attention in the dementias, which accompany memory loss, and that these deficits also respond to anticholinesterase therapy.
A new form of dementia, Dementia with Lewy bodies, has attentional impairment as a core feature, and this has recently been shown to respond dramatically to an anticholinesterase. Herbal compounds such as ginkgo and ginseng have also recently been shown, using such tests, to improve performance in students and normal middle aged volunteers. New developments, including administration of cognitive tests automatically either over the telephone or via the Internet, will greatly facilitate the application of cognitive function testing to large-scale clinical trials.
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