[...] Neuropsychological functions other than those evaluated with the ADAS-COG [...] are
also relevant to the treatment of patients with dementia. [...] McKeith and coworkers show that other features, such as psychological symptoms and reaction limes, can be meaningful outcome measures in dementia drug trials. These effects seen in this trial were also large in magnitude: at. week 12 a factor score, power of attention, declined by 19% on placebo compared with an improvement of 23% on rivastigmine.36 From the above, it seems clear that there is little relevance Inhibitors,research,lifescience,medical for the ADAS for DLB, except possibly as a secondary measure to compare findings to previous trials with AD. Attention is a core feature of the disease, as is behavioral and mental slowing, which means that assessing attention, speed of access to
memory, as well as overall memory performance with a computerized system is clearly optimal. Another contribution Inhibitors,research,lifescience,medical to the estimation of clinical relevance in this trial was that the system used has a large normative databa.se/niis has allowed the clinical relevance of these Inhibitors,research,lifescience,medical data to be assessed. In this trial, rivastigmine reduced the DLB deficit on the power of attention factor (the difference between the DI ,B patients and age-matched controls) by 33%. 36 In other words, the attentional impairments in the patients were pushed one third of the way back towards being normal, a large effect size and one for which the clinical relevance is clearly apparent. This should be contrasted with the ADAS, which does not have a database Inhibitors,research,lifescience,medical of scores
for normals. The only way of assessing the clinical relevance of effects on ADAS-COG is to use the number of points moved in order to estimate how long treatment may prevent, the patient from becoming institutionalized. Inhibitors,research,lifescience,medical This is obviously important, and the computerized system also has similar longitudinal data and can thus make this assessment; but. describing treatment response in terms of the degree to which the patient has been “normalized” is an extremely valuable extra piece of information that has far more intuitive appeal. This trial confirmed that computerized cognitive tests can be suitable and effective as primary outcome variables in dementia trials. More importantly for DLB, Ketanserin it illustrated that automated tests that incorporate sensitive measures of attention and other cognitive skills not. JQ1 assessed by the ADAS are more suitable primary outcome measures. It. is clear from this important trial that for DLB, the ADAS does not. have a role as a primary outcome variable in pivotal trials, though it. should be included as a secondary measure to enable comparisons to be made to the effects of other treatments in AD.