Objective: To evaluate cognitive response rates during long-term treatment with galantamine in patients with Alzheimer’s disease (AD), probable vascular dementia (VaD), and dementia related to cerebrovascular disease (CVD).
Design: After participating in double-blind, placebo-controlled trials, patients were eligible to enter one of 3 long-term extension studies (12 months or more) with galantamine 24 mg/day. Study 1 included 240 patients with AD treated for 36 months (including initial double-blind treatment). Study 2 included 699 patients with AD treated for 18.5 months. Study 3 included 459 patients with probable vascular dementia (VaD) or AD + CVD treated for 12 months.
Materials and Methods: The Alzheimer’s Disease Assessment Scale–cognitive subscale (ADAS-cog) was used to assess changes in cognitive function. Proportions of responders, defined as patients with no change or improvement (ADAS-cog change ³ 0), or with improvement of ³ 4, ³ 7, or ³ 10 points, were determined.
Results: Consistently high responder rates were seen at Month 12 in all 3 open-label studies. The percentage of patients whose cognitive function was improved or unchanged at Month 12 (ADAS-cog change ³ 0) was 52% in Study 1, 52% in Study 2, and 60% in Study 3. Moreover, almost half (44%) the AD patients in Study 2 showed ADAS-cog changes ³ 0 after 18.5 months, with approximately 1 in 4 (23%) showing clinically relevant improvement (³ 4-point reductions on the ADAS-cog); more than 10% of patients improved by ³ 7 points. Nearly 1 in 5 (18%) patients with AD showed ADAS-cog changes ³ 0 after 36 months in Study 1. In Study 3, approximately one third (32%) had reductions of ³ 4 points on the ADAS-cog at Month 12.
Conclusion: Benefit exists for the majority of patients treated, although this takes the form of slower rates of decline than experienced by untreated patients. Using the strict criterion of maintenance of baseline scores, galantamine maintained cognition at 12 months in up to two thirds of patients with AD, VaD, or AD + CVD. These benefits are evident after 3 years of treatment, and up to 1 in 5 patients with AD continuously treated with galantamine have cognitive scores that remain equal to or improved from baseline values.
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