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

• ClinicalTrials.gov Identifier: NCT00236431
• Recruitment Status: Completed
• First Posted: October 12, 2005
• Last Update Posted: June 8, 2011
• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Information provided by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Dementia; Alzheimer Disease	Drug: Galantamine hydrobromide	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1063 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: May 2001
• Actual Study Completion Date: December 2003

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators

• Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial; Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

More Information

Additional Information:

A study to evaluate the efficacy and safety of galantamine in patients with mild cognitive impairment. 

• ClinicalTrials.gov Identifier: NCT00236431
• Other Study ID Numbers: CR002014
• First Posted: October 12, 2005
• Last Update Posted: June 8, 2011
• Last Verified: November 2010

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Mild cognitive impairment; Galantamine hydrobromide; Memory disorders

Additional relevant MeSH terms:

Alzheimer Disease; Cognitive Dysfunction; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Galantamine; Cholinesterase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Neurotransmitter Agents; Physiological Effects of Drugs; Parasympathomimetics; Autonomic Agents; Peripheral Nervous System Agents; Nootropic Agents