Bullock, R.A. and Erkinjuntti, T. and Lilienfeld, S. (2004) Management of patients with Alzheimer's disease plus cerebrovascular disease: 12 month treatment with galantamine. Dementia and Geriatric Cognitive Disorders, 17 (1-2). pp. 29-34. ISSN 1420-8008.
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We evaluated the long-term cognitive effects and safety of galantamine 24 mg/day in patients with Alzheimer's disease plus cerebrovascular disease ( AD + CVD or mixed dementia). Subgroup analysis was performed of patients with AD + CVD who participated in a 6-month, multicenter, randomized, double-blind, parallel-group study and a 6-month, open-label, active-treatment extension. Method: Two hundred and eighty-five patients with AD + CVD were randomized to receive either placebo (n = 97) or galantamine 24 mg/day (n = 188) for 6 months. Two hundred and thirty-eight (84%) patients continued with the open-label phase of the study ( 86 from the placebo group, 152 from the galantamine group) and were treated with galantamine 24 mg/day. The primary efficacy measure was cognitive performance as assessed using the eleven-item cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-cog/11). Standard safety evaluations and adverse-event monitoring were performed throughout the 12-month study period. Patients with AD + CVD treated with galantamine experienced statistically and clinically significant improvement in cognition at month 6 ( mean change in ADAS-cog/11 score -1.1; p less than or equal to 0.05 vs. baseline) and maintained their cognitive function for the entire 12-month study (mean change in ADAS-cog/11 score + 0.1). In contrast, the cognitive function deteriorated among those in the placebo group (mean change in ADAS-cog/11 at month 6 + 2.0; p less than or equal to 0.001 vs. baseline). Patients with AD + CVD who were switched from placebo to galantamine for the open-label phase of the trial did show improvement in cognitive function; however, they never attained the same cognitive level as patients who had been treated with galantamine for the entire 12 months [mean (+/- SE) ADAS-cog/11 scores in the placebo/galantamine group 25.7 +/- 1.32 and 24.2 +/- 1.57 at months 6 and 12, respectively, and in the galantamine/galantamine group 21.5 +/- 0.87 and 22.2 +/- 1.06 at months 6 and 12, respectively]. The results of this subgroup analysis indicate that galantamine is effective for long-term maintenance of the cognitive function in patients with AD + CVD and is safe and well tolerated in this patient population.
|Uncontrolled keywords:||Alzheimer's disease; cerebrovascular disease/Alzheimer's disease galantamine; vascular dementia|
|Divisions:||Faculties > Science Technology and Medical Studies > Kent Institute of Medicine and Health Sciences (KIMHS)|
|Depositing User:||M.P. Stone|
|Date Deposited:||17 Sep 2008 16:08|
|Last Modified:||17 Sep 2008 16:08|
|Resource URI:||http://kar.kent.ac.uk/id/eprint/12060 (The current URI for this page, for reference purposes)|
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