Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease

This study has been completed.

Sponsor:

Information provided by:

Novartis

ClinicalTrials.gov Identifier:

NCT00099242

First received: December 10, 2004

Last updated: December 17, 2007

Last verified: December 2007

History of Changes

Tracking Information
First Received Date ^ICMJE	December 10, 2004
Last Updated Date	December 17, 2007
Start Date ^ICMJE	November 2003
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: May 30, 2006)	Change in cognition from baseline at week 24 Global clinical impression of change from baseline at week 24
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00099242 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 30, 2006)	Change from baseline at week 24 in activities of daily living Change from baseline at week 24 in behavioral symptoms Change from baseline at week 24 in global cognitive testing Change from baseline at week 24 in executive function Change from baseline at week 24 in attention
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease
Official Title ^ICMJE	Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease
Brief Summary	The goal of this research study is to evaluate the safety and efficacy of the rivastigmine transdermal patch in patients with probable Alzheimer's Disease.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Alzheimer's Disease Dementia, Alzheimer Type
Intervention ^ICMJE	Drug: rivastigmine transdermal patch
Study Arm (s)	Not Provided
Publications *	Alva G, Grossberg GT, Schmitt FA, Meng X, Olin JT. Efficacy of rivastigmine transdermal patch on activities of daily living: item responder analyses. Int J Geriatr Psychiatry. 2011 Apr;26(4):356-63.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	1040
Completion Date	January 2006
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: Diagnosis of dementia of the Alzheimer's type Males, and females who are surgically sterile or one year postmenopausal A primary caregiver willing to accept responsibility for supervising the treatment Exclusion Criteria: Any condition (other than Alzheimer's) that could explain patient's dementia An advanced, severe or unstable disease that may put the patient at special risk Current diagnosis of active, uncontrolled seizure disorder or unstable cardiovascular disease
Gender	Both
Ages	50 Years to 85 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Chile, Czech Republic, Denmark, Finland, Germany, Guatemala, Israel, Italy, Korea, Republic of, Mexico, Norway, Peru, Poland, Portugal, Puerto Rico, Russian Federation, Slovakia, Sweden, Taiwan, Venezuela

Administrative Information
NCT Number ^ICMJE	NCT00099242
Other Study ID Numbers ^ICMJE	CENA713D2320
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Novartis
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Novartis
Verification Date	December 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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