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

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00099242
• Other study ID #: CENA713D2320
• Status: Completed
• Phase: Phase 3
• First received: December 10, 2004
• Last updated: October 12, 2017
• Start date: November 2003
• Est. completion date: January 2006

Study information

• Verified date: October 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1040
• Est. completion date: January 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Dementia
• Dementia, Alzheimer Type

Intervention

Drug:
• rivastigmine transdermal patch

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Venezuela,  Chile,  Czechia,  Denmark,  Finland,  Germany,  Guatemala,  Israel,  Italy,  Korea, Republic of,  Mexico,  Norway,  Peru,  Poland,  Portugal,  Puerto Rico,  Russian Federation,  Slovakia,  Sweden,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cognition from baseline at week 24
Primary	Global clinical impression of change from baseline at week 24
Secondary	Change from baseline at week 24 in activities of daily living
Secondary	Change from baseline at week 24 in behavioral symptoms
Secondary	Change from baseline at week 24 in global cognitive testing
Secondary	Change from baseline at week 24 in executive function
Secondary	Change from baseline at week 24 in attention