Recent initiatives have resulted in guidelines for the assessment of cognitive function in specific clinical populations including the MATRICS consensus cognitive test battery for schizophrenia and the EMEA guideline on medicinal products for the treatment of Alzheimer s disease and other dementias. There are a number of common criteria that emerge, including assessment of cognition at the level of individual cognitive domains; validation; utility; utility as a repeated measure; and data allowing interpretation of results and understanding of the clinical relevance (i.e., normative/relationship to functional outcomes). It is apparent that such common criteria could usefully be applied to cognitive function assessment in all clinical populations. The publication of normative data is of use in the interpretation of clinical trials data.
Methods:
Five-hundred and seventy (570) patients with newly diagnosed epilepsy, aged 12-75 years, from 21 countries within Europe, Latin America, and Australasia, not previously exposed to AEDs, were recruited to a clinical trial comparing the efficacy and safety of remacemide versus carbamazepine. Patients completed a 30 minute cognitive test battery comprised of the CDR System; Rey auditory verbal learning test; color-word Stroop test; symbol digit modalities test; Lafayette grooved pegboard; digit cancellation test; and the non-verbal matrices subtest of the Kaufman brief intelligence test. Normative data in treatment-naïve patients across the studied age range were generated.
Results:
Assessments showed a common relationship with age, with those patients in the younger adult age cohorts tending to perform better on all measures than older patients and also than the youngest age cohort patients.
Conclusions: These data may be useful in the analysis and interpretation of cognitive assessment data from clinical trials of AEDs and/or studies in similar patient populations.