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Galantamine's Long-Term Safety, Efficacy In Alzheimer's Confirmed: Presented at ANA

By Jill Stein,
Special to DG News

NEW YORK CITY, NY -- October 15, 2002 -- Galantamine (Reminyl) is effective for 48 months and well tolerated for at least 54 months when used in patients with mild to moderate Alzheimer's disease (AD), say researchers.

Dr. Murray Raskind, with the VA Puget Sound and University of Washington in Seattle, United States reported these results at the 127^th Annual Meeting of the American Neurological Association (ANA).

Patients from two six-month, double blind, placebo-controlled studies received galantamine, 24 mg per day, for an additional 30 months in an open- label extension study. Although the primary objective was long-term safety, cognition at month 36 was also assessed using the 11-item Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog/11). Overall, 240 patients were enrolled in this investigation, known as GAL-INT-13.

In another open-label extension trial, patients from three prior open- label extension studies received galantamine, 24 mg per day, for an additional 18 months, for a total of 30 to 54 months of continuous galantamine treatment. The primary endpoint was safety. Overall, 676 patients were enrolled in this investigation, known as GAL-USA-18.

Results showed that the ADAS-cog scores of patients treated with galantamine deteriorated at a slower rate over the course of both studies than the predicted decline for untreated patients.

In GAL-INT-13, patients treated continuously with galantamine for up to 48 months demonstrated an approximate increase in ADAS-cog/11 score of 12.8 ± 11.86, compared with an estimated decline (increase in score) of 26 to 32 points predicted for untreated patients (ie. the deterioration in galantamine was les than half what was expected).

In GAL-USA-18, the ADAS-cog 11 scores of patients continuously treated with galantamine (12.39 ± 1.82) increased more slowly over 36 months compared with the predicted increase of 20.5 to 22.0 points estimated by the Stern equation.

Patients treated with galantamine maintained their ADAS-cog/11 scores at or above baseline for 12 months and gained 12 to 18 months in preservation of cognition relative to the predicted placebo decline.

Galantamine was well tolerated throughout both studies. Most adverse events were transient and of mild to moderate severity and were consistent with prior clinical trials. The adverse events seen most frequently were psychiatric disorders characteristic of an elderly population with AD (agitation, insomnia, and depression). Fall and injury were the most serious adverse events in both studies. Both are characteristic of an elderly AD population.

The percentage of patients who discontinued treatment due to adverse events was 5.4 and 10.1 percent in GAL-INT-13 and GAL-USA-18, respectively.

Galantamine is unique among acetylcholinesterase inhibitors as it has a dual mode of action - galantamine is a reversible acetylcholinesterase inhibitor and an allosteric modulator of nicotinic receptors, increasing the response to acetylcholine in the synaptic cleft.

The study was sponsored by Janssen Pharmaceutica Products in Titusville, New Jersey.

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