Treatment of Severe Alzheimer's Disease: Evaluation of Efficacy and Safety of Galantamine Hydrobromide in a Controlled Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00216593|
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : June 21, 2011
|Condition or disease||Intervention/treatment||Phase|
|Dementia Alzheimer Disease||Drug: galantamine hydrobromide||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||415 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Treatment of Severe Alzheimer's Disease in a Residential Home, Nursing Home, or Geriatric Residential Setting: Evaluation of Efficacy and Safety of Galantamine Hydrobromide in a Randomised, Doubleblind, Placebo-Controlled Study.|
|Study Start Date :||December 2003|
|Actual Primary Completion Date :||September 2007|
|Actual Study Completion Date :||March 2008|
U.S. FDA Resources
- Change in scores from baseline to week 26 on measuring cognition Severe Impairment Battery test and the Minimum Data Set Activities of Daily Living test.
- Results from Neuro Psychiatric Inventory-nursing home version test. Safety assessments include reports of adverse events, physical exam, vital signs, electrocardiograms, and laboratory test results.
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): NCT00216593
|Study Director:||Janssen Pharmaceutica N.V. Clinical Trial||Janssen Pharmaceutica N.V.|