NCT00236574

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: 974 (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. Following a 4 week screening period, patients with mild cognitive impairment (MCI), who are clinically at risk for development of Alzheimer's disease, will be randomized to treatment with either placebo or galantamine for 24 months with either placebo or a flexible dose of galantamine. Efficacy will be evaluated by measures of memory and cognition (Alzheimer's Disease Assessment Scale of cognition for MCI \[ADAS-cog/MCI\] and the Clinical Dementia Rating Sum of the Boxes \[CDR-SB\]), global severity of dementia (Clinical Dementia Rating \[CDR\]), functionality (Alzheimer's Disease Cooperative Study - Activities of Daily Living adapted to MCI \[ADCS-ADL/MCI\]), and changes on serial magnetic resonance imaging (MRI). Safety will be assessed using adverse event reports, vital signs, laboratory parameters, physical examination and electrocardiograms. The primary study hypothesis is that galantamine will improve memory deficits associated with mild cognitive impairment and therefore improve or stabilize the patient's cognitive abilities. A second study hypothesis is that treatment with galantamine slows or delays conversion of mild cognitive impairment to the dementia often associated with probable Alzheimer's disease in these patients. The third study hypothesis is that the treatment will be well tolerated by the patients. Galantamine hydrobromide immediate-release tablets (4, 8, and 12 milligrams (mg)) taken by mouth 2 times daily: 4 weeks at 8mg/day, 4 weeks at 16mg/day, increased to 24mg/day for the remainder of the 24-month trial. Dose 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: 2003-11-01
• First posted: 2005-10-12
• Last updated: 2011-06-08