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Trial record 1 of 1 for:    NCT00236431
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A Study to Evaluate the Efficacy and Safety of Galantamine in Patients With Mild Cognitive Impairment

This study has been completed.
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Identifier:
First received: October 7, 2005
Last updated: June 6, 2011
Last verified: November 2010
The purpose of this study is to evaluate the efficacy and safety of galantamine treatment in patients with mild cognitive impairment.

Condition Intervention Phase
Alzheimer Disease
Drug: Galantamine hydrobromide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • 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:
  • 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.

Enrollment: 1063
Study Start Date: May 2001
Study Completion Date: December 2003
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.

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

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
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Please refer to this study by its identifier: NCT00236431

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Additional Information: Identifier: NCT00236431     History of Changes
Other Study ID Numbers: CR002014
Study First Received: October 7, 2005
Last Updated: June 6, 2011

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Mild cognitive impairment
Galantamine hydrobromide
Memory disorders

Additional relevant MeSH terms:
Alzheimer Disease
Cognition Disorders
Mild Cognitive Impairment
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Nootropic Agents processed this record on May 23, 2017