To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: DG DISPATCH - ISSSAT: Aricept Leading Therapy For Alzheimer's Disease URL: http://www.pslgroup.com/dg/195B9A.htm Doctor's Guide April 7, 2000
By Cameron Johnston Special to DG News
STOCKHOLM, SWEDEN -- April 7, 2000 -- The latest research with Aricept (donepezil) confirms and extends what has already been learned in three- and six-month trials -- the effects of the drug do not wear off over at least one year and, more likely, two and perhaps three years.
Dr. Bengt Winblad, a professor in the department of geriatric medicine at Sweden's Huddinge University Hospital, noted that since coming to market world-wide in 1997, Aricept has claimed 70 per cent of the market for Alzheimer's therapies in Sweden. Sweden, in fact, has more drugs approved for the treatment of Alzheimer's than any country in the world.
Dr. Winblad spoke at the 6th International Stockholm-Springfield Symposium on Alzheimer Therapy (ISSSAT), in Stockholm, Sweden, this week.
The results of the Nordic Study -- which was conducted among subjects in Norway, Finland, Denmark, Sweden and the Netherlands -- show conclusively that people with the disease still perform as well as they did at baseline on a number of scales even after a year and more. These measures include the Mini Mental State Exam (MMSE), the Alzheimer's Disease Functional Assessment and Change Scale (ADFACS), the Clinical Rating or Dementia (CDR) and the Activities of Daily Living: Progressive Deterioration (ADL-PD) scale.
The study involved 286 patients with a mean MMSE score of approximately 19. Subjects in the study were divided according to MMSE scores, with those scoring 20 or lower being defined as moderate dementia and those scoring higher than 20 being defined as mild dementia.
One of the major findings from the study was that patients in the moderate dementia group experienced a mean decline in MMSE scores of 0.94 points as compared with those in the placebo group who experienced a decline of 3.56 points.
Among those patients whose dementia was defined as mild, the decline from baseline was 0.39 as compared with those in the placebo group whose decline was 1.06.
Similarly, the mean change from baseline in the ADL-PD scale was 10 as compared with those in the placebo group, whose mean change from baseline was 15. The ADL-PD scale looks at 27 different tasks of daily living such as being able to cook a meal and clean the house, but also such functions as using the telephone and mailing a letter.
Significant differences were recorded on the Global Deterioration Scale between the treatment and the placebo groups at weeks 24, 36 and 52.
Furthermore, the GBS-1 scale (Gottfries-Brane-Steen-1) -- a measure of how well the patient functions in an interview with a clinician -- coupled with observations provided to the clinician by a significant caregiver, showed significant differences between patients in the Aricept group compared with those in the placebo group.
"This means that not only are these numbers important, but that there was less deterioration, and that is clinically important," Dr. Winblad said.
There were no statistically significant differences between the treatment groups with regards to motor functions, emotional functioning and the development of pathological functioning. Dr. Winblad commented that this lack of improvement in the treatment group compared to the placebo group could be due to the already low scores at baseline for each of these three domains.
Although the trend for cognitive benefits in the patients with mild Alzheimer's was smaller than in the moderate dementia population, this could be because the scales used in this trial were less sensitive to change in mild as compared with moderate dementia, he added.
This trial indicates that patients with mild to moderate Alzheimer's maintained levels of cognition close to baseline for a period of at least one year, and patients with mild disease maintained levels of cognition at or above baseline levels according to their MMSE scores for a year, Dr. Winblad concluded.
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