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

Phase 3

Completed

• Conditions: Dementia; Alzheimer Disease

• Registration Number: NCT00236431
• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Brief 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.

Study Timeline

• Study Start: 2001-05
• Study Completion: 2003-12
• Study First Submitted: 2005-10-07
• Study First Submitted QC: 2005-10-07
• Study First Posted: 2005-10-12
• Status Verified: 2010-11
• Last Update Submitted: 2011-06-06
• Last Update Posted: 2011-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1063

Inclusion Criteria

• Clinical decline of cognitive ability consistent with mild cognitive impairment
• Delayed recall score <= 10 on a New York University paragraph recall test
• Sufficient visual, hearing and communication capabilities and be willing to complete serial standard tests of cognitive function
• Have a consistent informant to accompany them on scheduled visits
• Be able to read, write and fully understand the language of the cognitive scales used in the study

Exclusion Criteria

• Neurodegenerative disorders such as Parkinson's disease
• Cognitive impairment resulting from acute cerebral trauma, hypoxic cerebral damage, vitamin deficiency states, infections such as meningitis or AIDS, or primary or metastatic cerebral neoplasia
• Epilepsy
• Significant psychiatric disease
• Peptic ulcer disease
• Clinically significant heart, lung, liver or kidney diseases
• Pregnant or nursing women or those without adequate contraception

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Memory and cognition (ADAS-COG/MCI and CDR-SB scores), global functional skills and overall severity of dementia (the CDR-SB and the overall Clinical Dementia Rating) measured at 12 and 24 months.

Secondary Outcome Measures

Name	Time	Method
Digit Symbol Coding and Alzheimer's Disease Cooperative Study-ADL scale (MCI version) at 12 and 24 months. Safety assessment (reports of adverse events, laboratory values, results of physical examinations, and electrocardiograms) throughout the study.