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

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00236431
First received: October 7, 2005
Last updated: June 6, 2011
Last verified: November 2010

October 7, 2005
June 6, 2011
May 2001
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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.
Same as current
Complete list of historical versions of study NCT00236431 on ClinicalTrials.gov Archive Site
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.
Same as current
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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

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Dementia
  • Alzheimer Disease
Drug: Galantamine hydrobromide
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1063
December 2003
Not Provided

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00236431
CR002014
Not Provided
Not Provided
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Not Provided
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP