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Patients with Alzheimer's Disease who Discontinue Reminyl (Galantamine) Treatment with Seem to Experience Cognitive Decline: Presented at ICAD

TITUSVILLE, NJ -- August 23, 2004 -- New data presented recently at the International Conference on Alzheimer's Disease suggest that patients with mild to moderate Alzheimer's disease who continued treatment with ReminylŪ for a six-week period maintained improvement in cognitive function, compared to patients who discontinued treatment and experienced a significant, rapid cognitive decline during the same period of time.

These findings are from a post hoc analysis of two double blind, placebo- controlled pivotal trials, one with patients who had been treated with Reminyl for five months and another study with treatment lasting three months. A group of patients from both studies, who had been taking Reminyl, were given placebo for six weeks. The data suggest that the discontinuation of treatment led to a rapid decline in cognitive function that approached that of patients taking placebo.

"Unfortunately, some patients prematurely discontinue treatment for Alzheimer's disease, perhaps because they or their caregivers have difficulty seeing immediate benefits. They may not understand that the goal of treatment is to slow the progression of symptoms, and maintain function for as long as possible," noted Stephen Aronson, M.D., clinical assistant professor, University of Michigan, and a study co-author. "This study suggests the benefits from staying on treatment with Reminyl over time."

The research focused on patients' cognitive function, which includes the ability to think, reason and learn. The primary outcome measure in the analysis was the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog/11). In the first study, patients treated continuously with Reminyl at 16 mg/day maintained an improvement in ADAS-cog/11 score of 1.6 points at week six versus a deterioration of 0.8 points in the group switched to placebo and 1.4 points in the continuous placebo group. This study included a total of 723 patients, of whom 95 percent completed the study. Patients were randomized into groups receiving placebo or Reminyl at 8, 16 or 24 mg/day for five months; the group receiving 24 mg/day was withdrawn from Reminyl and placed on placebo for six weeks.

Similar results were seen in the second study. At week six, patients treated continuously with Reminyl at 24 or 32 mg/day (32 mg/day is not an approved dose) maintained an improvement in ADAS-cog/11 score of 1.5 points, while scores in the group switched to placebo deteriorated by 0.1 points, and the scores in the continuous placebo group by 0.9 points. While the patients withdrawn from Reminyl suffered deterioration in cognitive function, it was not as pronounced as that of patients continuously treated with placebo. This study included 118 patients, of whom 94 percent completed the study. Patients were randomized to receive placebo or Reminyl at 24 or 32 mg/day for three months. Following that time, patients receiving Reminyl were then either given placebo, or continued on the medication for six weeks at the same dose. The studies were supported by Janssen Medical Affairs, LLC.

Taken together, the studies did not find any serious adverse events in patients withdrawn from Reminyl. Adverse events were similar to patients continuously receiving placebo or Reminyl. These adverse events included depression, agitation, urinary tract infection, anxiety, headache, confusion and dizziness.

Like other Alzheimer's disease treatments that are acetylcholinesterase inhibitors, Reminyl enhances levels of the neurotransmitter acetylcholine, a chemical "messenger" responsible for sending signals between nerve cells in the brain, which is thought to play a key role in memory and learning, and is typically deficient in Alzheimer's disease. However, data suggest that Reminyl also has a modulating effect on the brain's nicotinic receptors. While the clinical significance of this mechanism is unknown, nicotinic receptors are thought to play a key role in attention, memory and learning.

Reminyl is indicated for treatment of mild to moderate Alzheimer's disease. The most frequent adverse events are nausea, vomiting, diarrhea, anorexia and weight loss. They are usually mild and temporary. For more information, refer to the full prescribing information for Reminyl or visit http://www.reminyl.com.

Janssen Pharmaceutica Products, L.P., the company that manufactures and markets Reminyl, provides a free support program for both caregivers and health care professionals called SharingCare. For more information visit http://www.SharingCare.com.

Reminyl was developed by Johnson & Johnson Pharmaceutical Research & Development under a co-development and licensing agreement with UK-based Shire Pharmaceuticals Group plc. The product is approved for the treatment of mild to moderate Alzheimer's disease in 66 countries.


SOURCE: Janssen Pharmaceutica Inc.

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