drugset / Trial / NCT00304629

Long-term Safety and Efficacy of Galantamine in Alzheimer's Disease

NCT00304629

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The long-term safety and efficacy of galantamine (12 mg bid) will be documented during a one year open-label treatment in subjects with Alzheimer's Disease who completed the GAL-INT-8 trial (up to 400 eligible patients). Safety will be tracked by means of adverse event reports, laboratory parameters and physical exam. Long-term efficacy will be evaluated by means of a Alzheimer's Disease Assessment Scale(ADAS) and activities of daily living scale Disability Assessment for Dementia Scale(DAD)

Timeline

Start
2000-03
Primary completion
Completion
2002-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Galantamine Small molecule 12 mg Oral

Indications