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)

Novartis

Status and phase: Completed; Phase 4

Conditions: Alzheimer's Disease

Treatments: Drug: Rivastigmine transdermal patch

Study type: Interventional

Funder types: Industry

Identifiers

NCT00622713

CENA713DFR08

N° EudraCT : 2007-003405-27

Details and patient eligibility

About

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

Enrollment: 228 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)