"One of the key characteristics of Alzheimer's disease is the serious impact it has not only on persons with the illness, but also on their family caregivers," explains Prof. Gordon Wilcock, one of the lead authors of the research and professor in the Department of Care of the Elderly at Frenchay Hospital at the United Kingdom's University of Bristol. "If a treatment can simultaneously benefit both of these groups, it would help to dispel the myth that Alzheimer's inevitably ends the productive lives of all involved. In addition, since the behavior of the patient, the time spent providing care and the overall burden on the family are significant factors in the decision to commit someone to a full-time-care facility, effective treatment with a medication like Reminyl may delay institutionalisation, which would have a positive economic impact."
Currently, it is estimated that as many as 17 million to 25 million people worldwide have Alzheimer's disease - a progressive loss of cognitive ability (thinking, remembering and reasoning) so severe that it interferes with an individual's ability to function and eventually leads to death.
Saving Caregiver Time
There were several research presentations at the IPA meeting this week that assessed the impact of Reminyl treatment on patient functioning by exploring the resulting impact on time required of family caregivers. One of these was an analysis led by Dr. Wilcock, which focused on the time caregivers spent supervising their family members or assisting them with activities of daily living, such as dressing and bathing.
Included in the analysis were 435 patients with mild to moderate Alzheimer's disease who had been randomly assigned to receive either 24 mg of Reminyl daily (220) or placebo (215) for six months as part of a larger study conducted in Europe and Canada. The primary efficacy measures used in the study were tools to assess patients' ability to learn, think and reason (the cognitive portion of the Alzheimer's Disease Assessment Scale) and the treating physician's overall impression of patients' function, along with input from caregivers (Clinician's Interview-Based Impression of Change plus Caregiver Information). However, as one of the secondary measures, the primary caregivers in the patients' families were asked to complete a questionnaire on the time they spent on supervision and assistance. The analysis found that the time required to supervise patients who received placebo increased by approximately two hours per day over the six months. In contrast, the time spent supervising individuals who took Reminyl did not increase significantly. In addition, the time that caregivers spent assisting patients on placebo with daily-living activities increased steadily throughout the trial, totalling an average of 23 extra minutes per day by the end of six months. On the other hand, caregivers of patients taking Reminyl reported a decrease in the amount of time spent assisting their charges by an average of 38 minutes per day.
"A reduction in time required for assistance isn't just a convenience and relief for the caregiver, it's also a reflection of increased independence for the person with Alzheimer's, which makes it a 'win-win' situation," comments Prof. Wilcock. "The longer we can preserve independent functioning for the patient, the more dignity and quality social interaction is possible."
Reducing Caregiver Stress
A separate analysis of a different study focused on caregiver distress and was conducted by Pierre Tariot, MD, professor of psychiatry, medicine and neurology at New York's University of Rochester Medical Center. He examined the data from a five-month study in which 286 U.S. patients with mild to moderate Alzheimer's disease were assigned to receive placebo, 279 took a maximum daily Reminyl dose of 16 mg and 273 received a maximum of 24 mg of Reminyl daily. Caregiver distress was assessed using a subscale of the Neuropsychiatric Inventory (NPI) -- one of the secondary measures of efficacy used in the study. Participating caregivers rated the degree of distress they experienced in response to 10 types of patient symptoms, such as hallucinations, delusions and agitation.
Dr. Tariot's analysis found that after five months, distress significantly increased among those caring for patients who took placebo. In contrast, distress scores were not significantly different at the end of the study than at the beginning for those caring for persons who received either one of the two Reminyl doses.
"This relative decrease in distress levels among caregivers with family members taking Reminyl may be due at least in part to the ability of the medication to delay the emergence of behavioral disturbances in many patients, including agitation, anxiety and hallucinations," comments Dr. Tariot. "The ultimate benefit may be that patients can stay at home longer, before full-time institutionalization or other types of chronic, professional care is required."
Safety and Tolerability
In a clinical study of 978 patients that included the recommended dosing regimen, the percentage of patients who dropped out due to side effects after taking Reminyl (7-10 per cent) was comparable to the discontinuation rate for individuals receiving placebo (7 per cent) . Overall, the most common side effects experienced by patients who followed the recommended schedule for Reminyl were primarily gastrointestinal in nature. Side effects that occurred in per cent or greater of patients included nausea, vomiting, anorexia, diarrhea and weight loss.
Reminyl is available by prescription in 4 mg, 8 mg or 12 mg tablets, as well as in an oral solution (4mg/ml). It should be taken by patients twice a day, preferably with morning and evening meals. It is recommended that physicians start by prescribing 8 mg of Reminyl per day (in two divided doses) for at least four weeks, then increase to the recommended maintenance dose of 16 mg per day. Physicians have the flexibility to increase the daily dose to 24 mg after an additional four weeks. More information on the product, including full prescribing information, can be found at www.reminyl.com.
Reminyl was first approved in Sweden in March of 2000, for the treatment of mild to moderate Alzheimer's disease. It is believed that Reminyl inhibits an enzyme that breaks down acetylcholine - a chemical in the brain that plays a key role in memory and learning. It also is believed that Reminyl modulates the brain's nicotinic receptors, to which acetylcholine binds. Laboratory research suggests that through this modulation, Reminyl stimulates greater release of acetylcholine. Research designed to define the significance of this finding in humans is underway.
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Notes to editors:
This news release has not been reviewed, approved or endorsed by the International Psychogeriatric Association.
Reminyl was developed by the Janssen Research Foundation under a co-development and licensing agreement with the UK-based Shire Pharmaceuticals Group plc.
Janssen Pharmaceutica NV is a wholly owned subsidiary of Johnson & Johnson (NYSE: JNJ) with a long track record in developing and marketing treatments for central nervous system disorders. Known as Janssen-Cilag in most countries, its other specialty areas include pain management, treatment of fungal infections and therapy for gastrointestinal conditions. More information on the company can be found at www.janssen-cilag.com.
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/hematology, 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 May 11, 2001. More information on the company can be found at www.shire.com.