Long-term Use of Galantamine Versus Nootropics (Memory Enhancing Drugs) in Patients With Alzheimer's Dementia Under Conditions of Daily Routine

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The main objective of this non-interventional study was to document the long-term application of galantamine and nootropics (memory enhancing drugs) over a period of 1 year under conditions of daily routine. There were no predefined specifications of diagnostic and therapeutic measures. The decision for treatment with either galantamine or a nootropic had to be made by the treating physician prior to the start of documentation. The following measures were to be documented: safety, tolerability, dementia-associated symptoms (unstable walking, vertigo, awakening at night, shouting/screaming at night, perambulating at night, aggressiveness, agitation, apathy/social retreat, delusions, hallucinations, behavior that poses a risk to self or others, and daytime tiredness), frequency of admissions to nursing homes or nursing services, global functional level, caregiver's burden, and time spent on caregiving. Furthermore, this study aimed to gather knowledge on the differentiated use of the two treatment strategies considering the specific diagnosis of dementia (e.g. Alzheimer's disease only or mixed dementia, i.e. Alzheimer's disease and cerebrovascular disease) and risk profiles.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen-Cilag G.m.b.H
• Treatments: Galantamine; Nicergoline; Nootropic Agents; Piracetam

Criteria

Inclusion Criteria:

• Patients were selected for documentation after the decision of treatment (galantamine or nootropic) had been made by the treating physician. Patients documented in this study were required to meet the following selection criteria: Diagnosis of probable mild or moderate dementia: Alzheimer type or mixed dementia (Alzheimer's and cerebrovascular disease)

• Mini-Mental-State Examination score = 24 at baseline (Visit 1), if possible

• Monotherapy with either galantamine or nootropic (the decision for treatment with either galantamine or a nootropic had to be made by the treating physician prior to the start of documentation)

• Patient had a caregiver to whom personal contact was possible at least 3 times per week

Exclusion Criteria:

• Patients were not eligible if they had received anti-dementive treatment with acetylcholinesterase inhibitors, memantine, or the same nootropic used during the observational period within the last 12 weeks prior to baseline