Cognitive function in patients with alzheimer's dementia and concomitant cerebrovascular disease treated with galantamine - a one year open-label phase-IIIb-study

Abstract

Background:

Galantamine has been demonstrated to be effective and generally safe in patients with Alzheimer's disease and cerebrovascular pathology (AD+CVD) in placebo-controlled trials. The aim of this open-label clinical trial (GAL-GER-5) was to observe cognitive function during long-term treatment with galantamine in patients with AD+CVD.

Methods:

Open-label, multi-center clinical trial (phase IIIb). Patients with mild to moderate AD+CVD (meeting NINDS-AIREN criteria) received galantamine (4-12 mg bid) for 12 months. Cognitive function was examined using the AKT ("Alters-Konzentrations-Test") and DemTect. Statistics were based on intent-to-treat population (LOCF, t-test and Wilcoxon-test for dependent samples).

Results:

84 patients (43% with mild, 56% with moderate AD+CVD; mean age±SD 75.5±6.8 years; 58% women) were enrolled. 80% of the patients completed the study. Modal daily galantamine dose was 16mg for 44%, and 24mg for 51% of the patients. After 12 months mean total score in AKT showed a stabilization from 49.0±6.7 (baseline) to 49.2±6.9 (p=0.7807) and DemTect increased significantly from 7.8±2.0 to 9.4±3.9 (p<0.0001). CGI demonstrated an improvement or stabilization for 71% of patients. 56% of the patients had at least one adverse event (AE). Most frequent AEs with an incidence >5% were nausea and vomiting. 8 patients discontinued due to AEs. 21 patients experienced a SAE with 4 SAEs considered as possibly related to study medication (heart failure, syncope, aggravated dementia, urinary retention).

Conclusions:

This open-label study supports evidence from placebo-controlled trials of the efficacy and safety of galantamine in patients with AD+CVD and suggests similar cognitive effects and safety through 12 months.