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Study Suggests Reminyl May Provide Long-Term Benefits in Treating Alzheimer's Disease: Presented at APA

Delay in Symptom Progression Observed Over Course of Three Years

PHILADELPHIA, PA -- May 22, 2002 -- Cognitive benefits of ReminylŪ (galantamine hydrobromide), the most recently approved medication for mild to moderate Alzheimer's disease, were sustained for up to three years for many patients compared to the predicted decline in untreated patients. These data were presented today at the 155^th Annual Meeting of the American Psychiatric Association. Researchers estimated that the decline in cognitive function -- including memory, learning and problem solving -- that is typically expected with Alzheimer's disease was slowed by approximately 18 months on average in patients who took Reminyl consistently over a three-year period.

"Progressive cognitive decline is a central feature of the deterioration seen in Alzheimer's disease, and if drug treatment can slow this downward spiral, the benefits to patients and their caregivers are often significant," says Murray Raskind, MD, lead study author and director of the University of Washington Alzheimer's Disease Research Center at the Department of Veteran's Affairs, Puget Sound Healthcare System.

Participants in the three-year analysis had originally enrolled in one of two double-blind trials in which Reminyl was compared to placebo.* At the completion of the studies, all patients were allowed to continue on in an "open-label" phase, in which each took 24 mg of Reminyl daily. A total of 327 patients entered the open-label extensions, of which 182 completed the trial, and 90 took Reminyl continuously for a full 36 months.

Using a standard scale known as ADAS-cog/11 to assess cognition, investigators compared patients treated continuously with Reminyl to the expected progression of untreated patients at 12, 24 and 36 months. The model for expected progression is based on a comprehensive, long-term study by Robert Stern, MD, at the University of Massachusetts that measured the decline over time of untreated Alzheimer's patients based on their baseline characteristics. The "Stern equation" is a widely used method for estimating cognitive decline in Alzheimer's disease patients.

A post-hoc analysis showed that, at three years, 53 percent of Reminyl-treated patients declined by 10 points or less on the ADAS-cog/11 scale, which is half of the cognitive decline predicted by historical data for untreated patients. In addition, approximately one in five (17.8 percent) Reminyl-treated patients had yet to drop significantly below baseline. When these results were compared to the expected course of the disease over three years in untreated patients, the researchers estimated that cognitive decline in Reminyl-treated patients was delayed by an average of approximately 18 months.

"Many people with Alzheimer's disease go untreated because of the mistaken belief among patients, family members and physicians that little can be done to help them," notes Dr. Raskind. "This study underscores that continuing treatment may slow symptom progression for at least three years."

In this three-year, open-label study (in which there were no untreated patients for a comparison), the most frequent side effects were agitation, urinary incontinence, falls, depression and insomnia. However, in the approved prescribing information for the medication, the most common side effects are listed as those that occur in five percent or more of patients and at rates at least twice that of placebo: nausea, vomiting, diarrhea, anorexia and weight loss. These side effects -- if they occur -- tend to happen when starting Reminyl or increasing the dosage, and are usually mild and temporary.

The newest approved treatment for mild to moderate Alzheimer's disease, Reminyl is thought to inhibit an enzyme that breaks down acetylcholine -- a critical chemical in the brain that plays a key role in memory and learning. In addition, it is believed that galantamine modulates the brain's nicotinic receptors, to which acetylcholine binds. Laboratory research suggests that through this action, galantamine stimulates greater release of the chemical. However, the significance of this finding in humans is currently unknown and further research is underway.

Reminyl was developed by Johnson & Johnson Pharmaceutical Research & Development, LLC., under a co-development and licensing agreement with UK-based Shire Pharmaceuticals Group plc. Marketed in the United States by Janssen Pharmaceutica Products, LP, the product is approved for the treatment of mild to moderate Alzheimer's disease in 30 countries. Reminyl also is being studied in related therapeutic areas such as vascular dementia. For more information on the product, please see accompanying full prescribing information, which can be found on http://www.reminyl.com.

* In one trial, patients with mild to moderate Alzheimer's were randomized to receive treatment for six months with either placebo or Reminyl at doses of 24 or 32 mg per day. Upon completion of the research, patients were allowed to enter an open-label phase in which everyone was treated with 24 mg of Reminyl daily for 30 months. In the other trial, patients with mild to moderate Alzheimer's disease were randomly assigned to receive either placebo or Reminyl at 24 to 32 mg daily for three months. This was followed by a six-week, double-blind withdrawal phase during which the control group continued to receive placebo and the treatment group was randomized to receive either placebo or continued Reminyl therapy. All patients who completed these two phases were allowed to continue treatment with the 24-mg dose for an additional 31.5 months.


SOURCE: Janssen Pharmaceutica Products, LP

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