Management of Patients with Alzheimer’s Disease plus Cerebrovascular Disease: 12-Month Treatment with Galantamine

Abstract

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 ≤ 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 ≤ 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.

Safety and efficacy of galantamine in subjects with mild cognitive impairment

“…[12][13][14][15] Galantamine, an acetylcholinesterase inhibitor and allosteric modulator of nicotinic receptors, has consistently demonstrated efficacy in the treatment of mild to moderate Alzheimer disease (AD). [23][24][25][26][27] This report presents the results of two large-scale, randomized, controlled clinical studies, both of which assessed the safety of galantamine in subjects with MCI, the effects of galantamine on cognition and global functioning in subjects with MCI, and the impact of galantamine on rates of conversion from MCI to dementia. [23][24][25][26][27] This report presents the results of two large-scale, randomized, controlled clinical studies, both of which assessed the safety of galantamine in subjects with MCI, the effects of galantamine on cognition and global functioning in subjects with MCI, and the impact of galantamine on rates of conversion from MCI to dementia.…”

Dementia Medications and Risk of Falls, Syncope, and Related Adverse Events: Meta-Analysis of Randomized Controlled Trials

“…Trials were assumed to have been conducted in the community unless specific descriptions of a nursing home or residential care setting were provided. This assumption was justified, because trials 31–59 that did not provide detailed information on residential status were conducted in participants with mild to moderate cognitive impairment.…”

Efficacy of Cholinesterase Inhibitors in Vascular Dementia: An Updated Meta-Analysis

“…All included studies were randomized controlled trials, where 5 studies investigated donepezil [15,19,21,23,25] , 5 evaluated galantamine [17,20,22,24,26] , and 2 studies assessed the efficacy of rivastigmine [16,18] . The age of patients ranged from 53.8 to 77.6.…”

“…2 a) [17,20,22,24,26] . There was no evidence of heterogeneity in the pooled difference of means for the efficacy of galantamine (Q = 6.32, p = 0.177, I-square = 36.7%).…”