NCT00236431

A Study to Evaluate the Efficacy and Safety of Galantamine in Patients With Mild Cognitive Impairment

A Randomized Double-Blind Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Galantamine in Patients With Mild Cognitive Impairment (MCI) Clinically at Risk for Development of Clinically Probable Alzheimer's Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,063 (actual)
• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of galantamine treatment in patients with mild cognitive impairment.

Detailed description

This is an international, multicenter, double-blind, randomized, placebo-controlled trial. Patients with mild cognitive impairment (MCI) who are clinically at risk for development of Alzheimer's disease will be treated for 24 months with either placebo or galantamine hydrobromide. Memory and overall clinical improvement will be evaluated using the Alzheimer's Disease Assessment Scale with cognitive subscale adapted to MCI (ADAS-cog/MCI) and the Clinical Dementia Rating Sum of the Boxes (CDR-SB). Overall functional skills and the severity of dementia will be assessed with the Clinical Dementia Rating Sum of the Boxes (CDR-SB) and the overall Clinical Dementia Rating (CDR) score. Additional assessments include the Digit Symbol Substitution Test (DSST) to measure attention. Safety will be assessed using adverse event reports, vital signs, laboratory parameters, physical examination, and electrocardiogram. The study hypothesis is that treatment with galantamine will be well tolerated and, compared with placebo, will significantly improve the signs and symptoms associated with mild cognitive impairment in patients who are considered likely to develop Alzheimer's disease. Galantamine hydrobromide immediate-release tablets (4, 8, or 12 milligrams), taken by mouth 2 times daily: 8mg/day for 4 weeks, 16mg/day for 4 weeks, then increased to 24mg/day for the remainder of the 24-month trial. Doses may be reduced at investigator's discretion after 12 weeks.

Conditions

• Dementia
• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	Galantamine hydrobromide

Timeline

• Start date: 2001-05-01
• Completion: 2003-12-01
• First posted: 2005-10-12
• Last updated: 2011-06-08