A 24 Week, Multicenter, Open, Evaluation of the Clinical Effectiveness of the Once-daily 10 cm^2 Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease (EXTRA)

NCT ID: NCT00622713

Last Updated: 2011-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 228 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2009-01-31

Brief Summary

This study is designed to confirm the efficacy, the tolerability, the patient compliance and the caregiver satisfaction with rivastigmine target patch size 10 cm^2 in patients with probable Alzheimer's Disease (Mini-Mental State Examination 10-26) in the community setting

Conditions

Alzheimer's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Rivastigmine transdermal patch

The study treatment was delivered as a patch sizes 5 and 10 cm\^2 containing respectively 9 and 18 mg of rivastigmine. During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm\^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm\^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm\^2.

Intervention Type: DRUG

Other Intervention Names

Exelon, Prometax

Eligibility Criteria

Inclusion Criteria

• Males, and females of at least 50 years old with a primary caregiver
• Probable Alzheimer's disease
• Mini-Mental State Examination (MMSE) score of ≥ 10 and ≤ 26
• Patients initiating therapy for the first time with a Cholinesterase (ChE) inhibitor (patients prescribed both rivastigmine and memantine are allowed) or patients who failed to benefit from previous ChE inhibitor treatment
• Residing with someone in the community throughout the study or, if living alone, in contact with the responsible caregiver everyday

Exclusion Criteria

• Patients not treated according to the product monograph for capsules
• Current diagnosis of an active skin lesion/disorder that would prevent accurate assessment of the adhesion and potential skin irritation of the patch (e.g., atopic dermatitis, wounded or scratched skin in the area of the patch application)
• History of allergy to topical products containing any of the constituents of the patches

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: lead

Responsible Party

Novartis

Principal Investigators

Novartis Pharma S.A.S.

Role: PRINCIPAL_INVESTIGATOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Rueil-Malmaison, , France

Countries

France

Other Identifiers

N° EudraCT : 2007-003405-27

Identifier Type: -

Identifier Source: secondary_id

CENA713DFR08

Identifier Type: -

Identifier Source: org_study_id