P0009 - Effects of galantamine in patients with Alzheimer's disease previously treated with nootropics, memantine or other cholinesterase inhibitors, a non-interventional study

Abstract

Background:

In this trial the tolerability of galantamine and the effects on cognition, behavior, caregiver burden and activities of daily living were assessed in patients who had been switched from therapies currently used in Germany to treat AD (memantine, nootropics, other AChEI).

Methods:

Prospective, non-interventional trial (GAL-DEM-4005). Patients with mild to moderate AD (ICD-10) were treated with 8-24mg/day galantamine. Clinical assessments included DemTect, NOSGER and CGI.

Results:

286 patients (ITT, LOCF; 35% with mild, 64% with moderate AD; mean age±SD 75.4±8 years; 54.5% women) were documented. Major reasons for transition were lack of efficacy and tolerability. 77.3% completed the study. After 159±50 days of treatment mean total score in DemTect changed significantly from 7.2±3.5 to 8.2±4.4 (p<0.0001). Clinical response (defined as decline of DemTect raw values ≤2 points) occured in 78.2% of ITT-population - in 82.6% with nootropic, 72.1% with other AChEI, and 70% with memantine pretreatment. NOSGER total scores remained stable with exception of significantly enhanced mood and ADL (p<0.05). CGI demonstrated an improvement or stabilization for 75.5% of patients. 35.0% had at least one AE. Most frequent AEs (>5%) were nausea, agitation and dizziness. 29 patients (10.1%) discontinued due to AEs. 23 patients experienced a SAE with 2 thereof considered as possibly related to galantamine by the treating physician (syncope, fall with lethal traumatic brain injury).

Conclusions:

In this non-interventional trial galantamine revealed favorable effects on cognition and behavior in patients with AD who had been pretreated with memantine, nootropics or other AChEI in daily routine.