drugset / Trial / NCT00814801

An Efficacy and Safety Study of Galantamine for the Treatment of Patients With Alzheimer's Disease

NCT00814801 ↗

Phase 3 Completed 580 enrolled Janssen Pharmaceutical K.K.
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of two fixed doses (16mg/day and 24mg/day) of galantamine (a drug for treating dementia) versus placebo for the treatment of patients with Alzheimer's disease.

Timeline

Start
2007-02
Primary completion
2008-09
Completion
2008-09

Outcome

Met primary endpoint

registry Placebo Group vs Galantamine Group 1; p = 0.0113; Mean Difference (Final Values) -1.49 (95% CI -2.64 to -0.34) NCT00814801 ↗

registry Placebo Group vs Galantamine Group 2; p <0.0001; Mean Difference (Final Values) -2.59 (95% CI -3.74 to -1.44) NCT00814801 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Galantamine Small molecule 16 mg Oral
Subject Galantamine Small molecule 24 mg Oral

Indications