A Study to Evaluate the Efficacy and Safety of Galantamine in Patients With Mild Cognitive Impairment
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|ClinicalTrials.gov Identifier: NCT00236431|
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : June 8, 2011
|Condition or disease||Intervention/treatment||Phase|
|Dementia Alzheimer Disease||Drug: Galantamine hydrobromide||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1063 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Completion Date :||December 2003|
U.S. FDA Resources
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00236431
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|