(On behalf of the EXPRESS Study Group Committee*)
Objective: Parkinson's disease dementia (PDD) is associated with substantial reductions of brain cholinergic markers. Rivastigmine is a brain-selective, dual inhibitor of acetylcholinesterase (AChE) and butyrylcholinesterase (BuChE). A number of case series and small open studies have indicated that rivastigmine may improve cognition, attention, sleep disturbances and psychotic symptoms in patients with PDD. These preliminary findings form the rationale for EXPRESS, a study aiming to assess the efficacy, safety and tolerability of rivastigmine in PDD.
Design: EXPRESS is a 24-week prospective, randomized, multicentre, double-blind, placebo-controlled, parallel-group study of the efficacy, tolerability, and safety of 3-12 mg/day of rivastigmine in patients with PDD.
Materials and Methods: Approximately 540 patients with Parkinson's disease dementia are being randomized to receive either rivastigmine or placebo in an assignment ratio of 2:1. The primary outcome measures are the Alzheimer’s Disease Assessment Scale cognitive subscale (ADAS-cog) and the Alzheimer’s Disease Cooperative Study - Clinician’s Global Impression of Change (ADCS-CGIC). Secondary efficacy parameters include detailed assessments of some cognitive domains such as executive functions and attention, functional abilities, behavioural symptoms, caregiver distress and burden. Exploratory pharmacogenetic research will be conducted during the study.
Results: The first patient was randomized in October 2002. Efficacy and safety results are expected to be available in 2004.
Conclusion: The rationale and methodology of the EXPRESS study will be presented.
*D Aarsland, A Albanese, J Byrne, G Deuschl, PP De Deyn, F Durif, M Emre, M Herrmann, J Kulisevsky, T van Laar, A Lees, W Poewe, A Robillard, E Wolters.
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