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the Assessment of Human Cognitive Function in Clinical Trials

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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By Professor Keith Wesnes, Chief Executive, and Chris Edgar, Scientific Manager of Cognitive Drug Research Ltd

Professor Keith Wesnes graduated from Reading University, UK in 1973 with a first class BSc in Experimental Psychology. He undertook an MRC-funded PhD using nicotine and scopolamine to identify the role of the cholinergic system in human attention. Between 1976 and 1986 he worked as a Research Fellow at Reading University and from 1983 to 1986 at Guy's Hospital, London. Keith has published over 100 peer reviewed research articles and chapters, and holds several university appointments including a Visiting Professorship at the Human Cognitive Neuroscience Unit at the University of Northumbria. He speaks frequently at national and international meetings. Keith founded Cognitive Drug Research in 1986, which provides automated cognitive function testing facilities for clinical trials.

Chris Edgar graduated from Sussex University, UK, in 1997 with a BA in Psychology. He went on to complete the MSc course in Research Methods in Psychology at Reading University. Chris joined Cognitive Drug Research as a Research Associate in 1999 and currently holds the position of Scientific Manager at the company. He has recently commenced PhD research investigating cognitive function and the serotonergic system at the University of Northumbria at Newcastle's Human Cognitive Neuroscience Unit

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Professor Keith Wesnes
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Chris Edgar
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