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Long-term Benefits Seen From Galantamine in Mild to Moderate Alzheimer's Disease: Presented at APA

By Paula Moyer

SAN FRANCISCO, CA -- May 26, 2003 -- The benefits of treatment with galantamine (Reminyl) continue to be seen up to 48 months in patients with mild-to-moderate Alzheimer's disease.

Atul R. Mahableshwarker, MD, presented results of a 4-year study on May 22^nd at the 2003 Annual Meeting of the American Psychiatric Association.

He said that the findings show that physicians need to view treatment with an acetylcholinesterase inhibitor as ongoing therapy, and not to be discouraged if patients show limited benefits after a few months. Dr. Mahableshwarker is a researcher at Janssen Pharmaceuticals and an adjunct associate professor of psychiatry at Chicago Medical School of the Finch University of Health Sciences in North Chicago, Illinois, United States.

"After 4 years, we saw a markedly lower decline from baseline in treated patients than would be expected in Alzheimer's disease," he said.

Dr. Mahableshwarker and his co-investigators conducted a 12-month open-label extension of two 36-month double-blind studies of galantamine.

The patients, who had a mean age of 74.5 years (60.8% women), were treated with 24 mg of galantamine daily during the treatment period. The investigators evaluated cognitive change with the cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-cog). They assessed treatment efficacy by the ADAS-cog change from baseline to month 48, and they assessed safety by documenting adverse events and changes in the electrocardiogram (ECG), vital signs, and analysis of blood and urine specimens.

Of 314 patients who had completed the previous studies, 240 continued in the extensions, with 185 (77.1%) completing the full 48 months of galantamine therapy. Among patients who did not complete the extension, 17.7% withdrew due to adverse events.

The 185 patients who completed the extension experienced some decline, reflected by an average increase in ADAS-cog score of approximately 12.8 points over baseline.

Dr. Mahableshwarker said that previous data show that the estimated decline for untreated patients would be an increase of 24 to 36 points in the ADAS-cog score. Therefore, the deterioration in galantamine patients was less than half that expected, he said.

The investigators documented a rate of 11% each for agitation and falls. The investigators observed no clinically relevant ECG or laboratory changes, Dr. Mahableshwarker said.

"This study shows that we shouldn't be focusing on short-term data in studies of treatments for Alzheimer's disease," said Stephen M. Aronson, MD, a clinical assistant professor at the University of Michigan Medical School, Ann Arbor, MI, United States. Dr. Aronson has been an investigator in previous trials of galantamine but was not involved in the current research.

"Alzheimer's disease is not a short-term illness," he said. "It's a long time from diagnosis to death. At this point, the best we can do is slow down the rate of deterioration." Dr. Aronson added that physicians should think of acetylcholinesterase inhibition as an ongoing treatment and look, not for improvement, but instead see stability and attenuation of the rate of decline as signs that the patient is benefiting from treatment.

The study was funded by Janssen Pharmaceuticals, the manufacturers of Nivalin.


[Study title: Long-Term Cognitive Effects In Time Of Galantamine In The Treatment A Mild-To-Moderate Alzheimer's Disease: Evidence For 48 Months Of Treatment. Abstract NR884]

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