[...] If clear advantages of computerized procedures are demonstrated, such procedures might supersede existing methods. This situation has led drug developers to seek more sensitive cognitive outcome measures. Regulators, particularly the Efficacy Working Party of the European Medicines Dinaciclib nmr Approval Agency, have also opened the possibility of using other, non-ADAS-COG measures. Clinical trials of drugs developed for the amelioration of dementia and especially

AD tend to require large numbers of study participants and are typically Inhibitors,research,lifescience,medical of quite long duration. Regulators both in Europe and the USA have specified the collection of extensive safety data in support of an application for a marketing license. For example, Leber has specified that a minimum level of safety information is to be based on data for N=1000 study participants collected over a 6-month period.32 Furthermore, a subset of at. least. N=300 participants must, be further studied for 1 year or Inhibitors,research,lifescience,medical more. However, with respect, to showing evidence of efficacy, a combination of modest degrees of drug efficacy and the use of relatively insensitive instruments has meant that typically hundreds of study participants are required for trials lasting at least 6 months and often Inhibitors,research,lifescience,medical considerably longer. Added to this situation

is the practical and ethical Inhibitors,research,lifescience,medical difficulty of recruiting patients for the placebo arm of these trials. These demanding requirements have made large, multicenter, international trials a necessity. The routine inclusion of the notoriously unreliable clinicians’ impression scales is seen as tacit acceptance of the failure of current, cognitive outcome measures to capture the clinically significant improvements seen in patients. It therefore seems

clear that pretenders to the ADAS-COG’s crown will benefit from being demonstrably robust, proxy measures of everyday cognitive improvement. Intuitively, it. seems reasonable to suppose that enhancements Inhibitors,research,lifescience,medical in cognition seen in laboratorybased assessments will be reflected as improvements in day-to-day activities reliant, upon reasonable degrees of cognitive competence. One method for validating laboratory-based methods would be to correlate them against concurrently run ADL and 17-DMAG (Alvespimycin) HCl quality of life questionnaires. The result of such a validation project, may well yield cognitive outcome measures that are powerful and accurate proxy measures of clinically significant drug enhancements. This validation has the potential to make clinicians’ rating scales redundant as a means of capturing the positive effects of pharmaceutical interventions. Dementia with Lewy bodies DLB accounts for 15% to 25% of all dementia.33 As described earlier, DLB is a newly diagnosed form of dementia for which consensus criteria have emerged in recent years.