ETNA3, a clinical randomized study assessing three cognitive-oriented therapies in dementia: rationale and general design.

Despite the popularity of cognitive-oriented therapies in dementia, very few data gathered from scientific literature provide a clear demonstration of the genuine efficacy of these techniques. Most of the results published have issued from studies suffering from important methodological limitations such as: absence of control group to compare clinical courses, very small size of study samples, absence of group randomization, absence of blind assessment of efficacy criteria or absence of long-term efficacy assessment. Randomized clinical trials are rare or even absent for some techniques and generally report more modest benefits. In this context, the ETNA3 study has been implemented. The ETNA3 study is a French nationwide prospective simple-blinded randomized clinical trial conducted to evaluate the impact of cognitive training, reminiscence therapy and an individualized cognitive rehabilitation program on the progression rate of dementia. The study was conducted in 653 outpatients with mild to moderate Alzheimer's disease followed up for 2 years (MMSE score 16 and 26). The main objective was to determine whether any or several of these non-pharmacological treatments could delay the severe stage of dementia during a 2-year follow-up compared to a usual care group without non-pharmacological treatment. The secondary outcomes assessed cognitive abilities, functional abilities in activities of daily living, behavioral disturbance, apathy, quality of life, depression, caregiver's burden and resource utilization. This article presents the rationale and methodology of the study.