NCT00301574

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

Placebo-Controlled, Double-Blind Study of Galantamine (R113675) in the Treatment of Alzheimer's Disease.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 398 (actual)
• Sponsor: Janssen Pharmaceutical K.K. · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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, and to investigate the dose-response.

Detailed description

This is a randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of two fixed doses of galantamine (16 and 24 milligrams per day \[mg/day\]) in patients with Alzheimer's disease, and to investigate the dose-response. The study consists of a 4-week screening period during which all patients will receive placebo, and a 22-week double-blind treatment period during which patients will receive placebo, galantamine 16 mg/day, or galantamine 24 mg/day. For patients receiving galantamine treatment, the starting dose is 8 mg/day and increases at 4-week intervals in increments of 8 mg/day. The primary measures of effectiveness are the change from baseline to the end of the study (week 22) in the Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog) and the Clinician's Interview-Based Impression of Change plus - Japan (CIBIC plus-J). Safety assessments include the incidence of adverse events, clinical laboratory tests, vital signs, electrocardiograms (ECGs), and physical examination findings. The study hypothesis is that galantamine will be more effective in the treatment of Alzheimer's disease than placebo. Study drug taken orally twice a day. 4-week screening period: All patients receive placebo. 22-week treatment period: Patients receive placebo, galantamine 16 mg/day, or 24 mg/day. For galantamine treatment, the starting dose is 8 mg/day and increases at 4-week intervals in increments of 8 mg/day.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	galantamine

Timeline

• Start date: 2001-04-01
• Completion: 2004-02-01
• First posted: 2006-03-13
• Last updated: 2011-05-17