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| |  Exelon (Rivastigmine Tartrate) May Help People With Dementia Associated With Parkinson's Disease BASEL, SWITZERLAND -- December 9, 2004 -- Exelon® (rivastigmine tartrate) can provide significant benefits in dementia associated with Parkinson's disease (PD), according to a study published in the New England Journal of Medicine this month. The study, known as EXPRESS (EXelon in PaRkinson's disEaSe dementia Study), is the first large-scale clinical trial assessing the efficacy and safety of an Alzheimer's disease treatment in PD patients with dementia.1 Exelon has been widely used in Alzheimer's disease dementia since its approval in 1997. Patients taking Exelon showed statistically significant benefits on a range of symptoms, such as loss of memory, concentration and behavioral problems. They were also able to cope better with everyday activities like watching TV or talking about current events. "The findings of the EXPRESS study could have important implications for clinical practice," said Dr Murat Emre, Professor of Neurology at the Istanbul University in Turkey, lead investigator of the EXPRESS study. "With current treatments we are able to manage the movement symptoms of Parkinson's disease quite well, but dementia has been an area which could not be treated up to now. Rivastigmine is a therapy that has been shown to improve symptoms frequently seen in patients suffering from dementia associated with PD and thus offers hope to provide a better quality of life," Dr. Emre said. Dementia is one of the complications most feared by PD patients.2 In addition to cognitive impairment, neuro-psychiatric symptoms like depression, hallucinations, anxiety and apathy, are also common. 3 These symptoms are important determinants of the patient's quality of life, course of the disease and caregiver distress.3 Two out of five people with PD develop dementia over the course of their illness. 4,5 Patients with PD have a six-fold increase in the risk of developing dementia compared with elderly people without PD. "Dementia associated with Parkinson's disease places a significant emotional, economic and social burden on patients and their families," said Mary Baker, President of the European Parkinson's Disease Association, which is based in the United Kingdom. "As the person with PD becomes increasingly dependent, watching someone that you care for start to deteriorate in this way is heart breaking, and the future becomes an uncertain abyss for all the family. Sometimes institutional care is the only option and this places a significant economic burden on the family and the state. Results like this give new hope to families caring for a loved one with dementia and may improve the quality of life of the whole family," Baker said. EXPRESS Study Results Patients who were treated with Exelon showed a mean 2.1-point improvement (versus a 0.7-point decline in placebo) on the ADAS-cog scores (p< 0.001) at week 24 of the study. Mean ratings on the ADCS-CGIC were 3.8 on rivastigmine versus 4.3 on placebo (p= 0.007). Additional specific tests for memory, attention, behavioral symptoms and verbal fluency consistently showed significantly better outcomes for Exelon versus placebo (all p< 0.05). Since patients receiving placebo declined by nearly 1 point on the ADAS-cog over 24 weeks, an improvement of 2.1 points in the rivastigmine group might represent approximately one year's advantage. The side effects associated with Exelon during this study were mild to moderate in nature and included nausea and vomiting. Importantly, motor scale assessments showed that Parkinsonian symptoms were not worsened overall relative to baseline or placebo. Mild to moderate tremor was reported in Exelon-treated patients, but this rarely resulted in withdrawal from the study. About Exelon Among the widely used ChEI's, Exelon is the only treatment that inhibits both enzymes involved in the breakdown of the neurotransmitter acetylcholine - acetylcholinesterase (AChE) and butyrylcholinesterase (BuChE). This may offer additional benefits over treatments which inhibit AChE alone. Exelon can maintain both memory and thinking, help with behavioral problems and affect how patients cope with the activities of daily living. It may help them communicate better, interact socially, participate in hobbies and eat and dress independently. 6,7 About Parkinson's Disease, Alzheimer's Disease and Dementia Like Alzheimer's disease, dementia associated with Parkinson's disease is thought to result from a cholinergic deficit, which causes decreased transmission of signals between nerves in the brain, especially those that rely on the neurotransmitter acetylcholine. This deficit contributes to the cognitive and behavioral problems observed in these patients. Patients with dementia associated with Parkinson's disease typically have problems with memory, concentration, activities of daily living, as well as depression, anxiety, apathy and hallucinations.5,10 Alzheimer's disease (AD) is a progressive, degenerative disease that alters the brain, causing impaired memory, thinking and behavior. Affecting approximately 10 million people worldwide and two to six percent of those over 65 years of age, it is the most common form of dementia and the third leading cause of death in this age group behind cardiovascular disease and cancer. 11 Dementia occurs in different forms such as Alzheimer's disease, vascular dementia, dementia associated with Parkinson's disease, dementia with Lewy bodies, and is currently estimated to affect nearly 18 million people worldwide. 12 As the mean age of the population increases, this number is steadily increasing.
References SOURCE: Novartis AG
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