At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 241 enrolled
Drug / intervention
galantaminedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Long Term Safety and Efficacy of Galantamine in Alzheimer's Disease (Extension INT-8)
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·interventional·Posted Mar 20, 2006·Updated Feb 1, 2011
In Brief
A Phase 3 clinical trial evaluating galantamine for Alzheimer Disease. Completed, enrolled 241 participants.
Detailed 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)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer Disease
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2000
Study CompletionMar 2002
First PostedMar 2006
TodayJul 2026
First PostedMar 20, 2006
Enrollment StartMar 1, 2000
Study CompletionMar 1, 2002
TodayJul 2, 2026
Posted 20.3 years ago
Interventions
galantaminedrug