A Study to Evaluate the Efficacy and Safety of Galantamine in Patients With Mild Cognitive Impairment
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|ClinicalTrials.gov Identifier: NCT00236574|
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 :||974 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|
|Actual Study Completion Date :||November 2003|
U.S. FDA Resources
- Memory and cognition (ADAS-cog/MCI and CDR-SB scores) at 12 months and Global functional skills and the overall severity of dementia (the CDR-SB and the overall CDR) at 24 months.
- Brain atrophy assessed by MRI, Digit Symbol Coding, Alzheimer's Disease Cooperative Study-ADL scale(MCI version) at 24 months. Safety evaluations (adverse event reports, vital signs, laboratory tests, physical examination, electrocardiograms) throughout.
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): NCT00236574
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|