London, UK, 19 June 2001- ReminylTM (galantamine), a new treatment for mild to moderate Alzheimer's disease derived from the daffodil, is the first medication of its kind shown to be potentially effective in treating dementia in patients with cerebrovascular disease, such as stroke.
Data from a study presented here today at the XVII World Congress of Neurology show that Reminyl improves memory, orientation and language skills of patients with vascular dementia or a combination of Alzheimer's disease and cerebrovascular disease ("mixed" dementia) for at least 12 months. The results also showed that Reminyl improved or maintained the ability of these individuals to perform normal activities of daily living, such as bathing, dressing and doing housework. However, Reminyl is not yet approved for the treatment vascular dementia.
"This study has the potential to make a real impact on the way dementia is treated throughout the world," says Dr Roger Bullock of the Kingshill Research Centre in Swindon, UK. "If the findings of this study are replicated through further research, physicians will no longer need to hesitate before treating dementia in individuals in whom vascular damage has occurred. Reminyl appears to be effective in treating dementia, whether or not cerebrovascular disease is present."
Dementia is a decline in memory and intellectual abilities that results in a significantly impaired ability to function.1 The most common type of dementia is Alzheimer's disease. However, the second most common type is vascular dementia, which often is triggered by one or more strokes and can be caused by uncontrolled hypertension or diabetes.
World-wide incidence of vascular dementia is estimated at six to 12 cases per 1,000 people more than 70 years of age.2 Many other individuals have a mix of Alzheimer's and cerebrovascular disease. In fact, it is estimated that between 10 and 50 per cent of individuals have either vascular or mixed dementia. Unfortunately, these individuals are often unrecognized or untreated.
Study Design and Results
To research the efficacy of Reminyl in this population, 592 patients diagnosed with vascular or mixed dementia were enrolled in an initial six-month, "double-blind" clinical study and received either 24mg per day of Reminyl (396) or placebo (196). Of this group, 459 individuals (295 who had taken Reminyl and 164 who had previously received placebo) continued the research for another six months in an "open-label" extension of the study. All participants in the open-label extension took 24mg of Reminyl daily, in two divided doses.
Several tools were used in the study to assess the effectiveness of Reminyl in both phases of the study. These included:
· The cognitive portion of the Alzheimer's Disease Assessment Scale (ADAS-cog), which measures
patients' memory, orientation, reasoning and language. At 12 months, the cognitive abilities of patients who had received Reminyl for the entire study period were better than when the individuals had commenced treatment. The cognitive performance of patients who were originally assigned to take placebo had declined upon completion of the study's initial six months. However, after being switched to Reminyl, these patients' cognitive abilities improved; after the final six months, their performance was better than at the start of the study.
· The Disability Assessment of Dementia (DA.D) scale, which assesses patients' ability to perform routine, daily-living activities. Over the course of the year, both groups of patients experienced a deterioration in their ability to do tasks such as bathing, dressing and housework. However, the decline in the group receiving placebo for the first six months was more than double that of the group receiving Reminyl for the entire year.
· The Neuropsychiatric Inventory (NPI), which monitors for behavioural disturbances, such as hallucinations, delusions, pacing and agitation. In the study, Reminyl delayed emergence of these behavioural symptoms in patients receiving active treatment for the entire study period, and alleviated such disturbances in individuals who were switched to Reminyl after six months' of placebo.
In the overall study, Reminyl was generally well tolerated by patients. Most side effects were gastrointestinal in nature, of mild to moderate severity and mainly confined to the period when the dose was being increased. Other research has shown that when the dose is increased at a slower rate, the occurrence of nausea and vomiting is not significantly greater than reported by patients taking placebo.
Mechanism of Action
Reminyl has a dual mechanism of action that is different from other Alzheimer's treatments that are currently available. In addition to inhibiting the breakdown of acetylcholine, a chemical in the brain critical to learning and memory, Reminyl has been shown in laboratory research to modulate "nicotinic receptors." It is believed that this results in the increased production of acetylcholine and other important chemicals in the brain.
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1 The Neurological Adaptation of the International Classification of Diseases (ICD-10NA: WHO, 1991)
2 Neurology: V.53; 12/1991 page 1992
Notes to editors:
Reminyl received marketing approval for the treatment of mild to moderate Alzheimer's disease last year in Europe and in February in the United States. Reminyl is dispensed in 4 mg, 8 mg or 12 mg tablets and should be taken by patients twice a day, preferably with the morning and evening meals. It is recommended that physicians start by prescribing 8 mg of Reminyl per day (in two divided doses), then increase the dose to 16 mg after at least four weeks. Physicians have the flexibility to increase the daily dose to 24 mg after an additional four weeks.
Reminyl was developed by the Janssen Research Foundation under a co-development and licensing agreement with the UK-based Shire Pharmaceuticals Group plc.
Janssen-Cilag (outside the US) and Janssen Pharmaceutica (U.S.) are wholly owned subsidiaries of Johnson & Johnson [NYSE: JNJ], with a long track record in developing and marketing treatments for central nervous system disorders. Other specialty areas include pain management, treatment of fungal infections and therapy for gastrointestinal conditions.
Shire Pharmaceuticals Group, plc, is a fast-growing international specialty pharmaceutical company with a strategic focus on four therapeutic areas: central nervous system disorders, oncology/haematology, antivirals and biologics. Shire entered into an agreement to merge with BioChem Pharma Inc. to form a leading global specialty pharmaceutical company; the merger was completed on 11 May, 2001. More information on the company can be found at www.shire.com.