Long-term Safety and Efficacy of Galantamine in Alzheimer's Disease
Status:
Completed
Trial end date:
2002-03-01
Target enrollment:
Participant gender:
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)
Phase:
Phase 3
Details
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.