An Efficacy and Safety Study of Galantamine for the Treatment of Patients With Alzheimer's Disease.
|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: NCT00301574|
Recruitment Status : Completed
First Posted : March 13, 2006
Last Update Posted : May 17, 2011
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease||Drug: galantamine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||398 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Placebo-Controlled, Double-Blind Study of Galantamine (R113675) in the Treatment of Alzheimer's Disease.|
|Study Start Date :||April 2001|
|Actual Study Completion Date :||February 2004|
U.S. FDA Resources
- Change from baseline to the end of the study in the Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog) and the Clinician's Interview-Based Impression of Change plus - Japan (CIBIC plus-J)
- Change from baseline to the end of the study in CIBIC plus-J subscales (Disability Assessment for Dementia [DAD], Behavioral Pathology in Alzheimer's Disease Rating Scale [Behave-AD], the Mental Function Impairment Scale [MENFIS ]).
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): NCT00301574
|Study Director:||Janssen Pharmaceutical K.K. Clinical Trial||Janssen Pharmaceutical K.K.|