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Title: Galantamine Delays Decline in Cognition by 12 to 18 Months: Presented at ECNP

"Galantamine Delays Decline in Cognition by 12 to 18 Months: Presented at ECNP"

By Mark Pownall Special to DG News BARCELONA, SPAIN -- October 9, 2002 -- The cognitive decline of patients with mild to moderate Alzheimer's disease can be delayed by 12 to 18 months with acetylcholinesterase inhibitor drug treatment, three year follow up data show. Professor Gordon Wilcock of the department of care of the elderly at Frenchay Hospital, University of Bristol, in Bristol, United Kingdom, presented results from two studies of patients from Europe and North America here at the 15th congress of the European College of Neuropsychopharmacology. He said that treatment with galantamine at a dose of 24 mg/day over 36 months allowed patients to gain 12 to 18 months in terms of preserved cognition relative to predicted placebo decline. Cognitive function was measured by the 11-item Alzheimer's Disease Assessment Score (ADAS-cog/11). In one study a 10- to 11-point decline in the score was reached by patients on placebo within 18 months of baseline, but by patients in the galantamine arm of the trial 36 months after baseline. The two trials reported, funded by Johnson & Johnson, were open-label extensions of previous double-blind clinical trials, extended to three years. Of the 818 patients in the trials 551 were on active treatment, and 340 (62 percent) were on treatment for the full 36 months. There were slightly more women (6 percent) in the trial than men (44 percent) and the mean age was 73, with a mini-mental state score at baseline of 18.8. The original trials found that ADAS-cog/11 scores remained at or above baseline for the first 12 months of treatment, but a decline, at a similar rate to placebo-treated patients at baseline, started after 12 months of treatment. The drug was well tolerated, the Bristol researchers said, with dropout rates caused by adverse events of about 12 percent -- 11.6 percent in the larger study and 13.1 percent in the smaller one. Professor Wilcock said the scale of the delay in decline of cognitive function was likely to be matched by an improvement in functional ability and improvements of quality of life. He stressed, however, that the analysis for functioning and quality of life has not yet been carried out. "This study shows a delay in decline of cognition which is linked to functional ability and quality of life issues. I am sure when we look there will be parallel changes in those parameters," he stated. The difference in cognitive function was appreciable, he added. "It is a big difference at the end of three years to get down the cognition score that those on placebo reached after 18 months." In a separate presentation, researchers including Dr. Andreas Monsch of the memory clinic at the Geriatric University Hospital is Basel, Switzerland, found improvements among 124 patients taking galantamine 8 mg twice a day in behavioural symptoms: anxiety, aberrant motor behaviour, delusions, euphoria, night-time behaviour, apathy, hallucinations, irritability and agitation. All these symptoms were reduced by more than 20 percent compared to baseline after three months. There was a significant reduction in the burden on caregivers between baseline and month 3 (p<0.05). This was measured with the Neuropsychiatry Inventory which can measure the demands of Alzheimer's on caregivers. This study was funded by Janssen Cilag.

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