A 24 Week, Multicenter, Open, Evaluation of the Clinical Effectiveness of the Once-daily 10 cm2 Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease (EXTRA)
Summary
This study is designed to confirm the efficacy, the tolerability, the patient compliance and the caregiver satisfaction with rivastigmine target patch size 10 cm2 in patients with probable Alzheimer's Disease (Mini-Mental State Examination 10-26) in the community setting
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Alzheimer's Disease
Intervention
Rivastigmine transdermal patch
Location
Novartis Investigative Site
Rueil-Malmaison
France
Status
Completed
Source
Novartis
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00622713
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Transdermal Patch
A medicated adhesive patch placed on the skin to deliver a specific dose of medication into the bloodstream.
Patch-clamp Techniques
An electrophysiologic technique for studying cells, cell membranes, and occasionally isolated organelles. All patch-clamp methods rely on a very high-resistance seal between a micropipette and a membrane; the seal is usually attained by gentle suction. The four most common variants include on-cell patch, inside-out patch, outside-out patch, and whole-cell clamp. Patch-clamp methods are commonly used to voltage clamp, that is control the voltage across the membrane and measure current flow, but current-clamp methods, in which the current is controlled and the voltage is measured, are also used.
Neuropil Threads
Abnormal structures located chiefly in distal dendrites and, along with NEUROFIBRILLARY TANGLES and SENILE PLAQUES, constitute the three morphological hallmarks of ALZHEIMER DISEASE. Neuropil threads are made up of straight and paired helical filaments which consist of abnormally phosphorylated microtubule-associated tau proteins. It has been suggested that the threads have a major role in the cognitive impairment seen in Alzheimer disease.
Alzheimer Vaccines
Vaccines or candidate vaccines used to prevent or treat ALZHEIMER DISEASE.
Aphasia, Primary Progressive
A progressive form of dementia characterized by the global loss of language abilities and initial preservation of other cognitive functions. Fluent and nonfluent subtypes have been described. Eventually a pattern of global cognitive dysfunction, similar to ALZHEIMER DISEASE, emerges. Pathologically, there are no Alzheimer or PICK DISEASE like changes, however, spongiform changes of cortical layers II and III are present in the TEMPORAL LOBE and FRONTAL LOBE. (From Brain 1998 Jan;121(Pt 1):115-26)
Clinical Trials
This study will use two doses of rivastigmine transdermal patch (5cm2, 10cm2) to establish the feasibility of 2 switch schedules (with transdermal patch one-step dose titration or without...
This study will assess the efficacy of a higher dose of rivastigmine patch (15 cm2) compared to a lower dose of the rivastigmine patch (5 cm2), in patients with severe dementia of the Alzh...
This study will evaluate compliance, tolerability, safety, efficacy and caregiver burden of rivastigmine patch 10 cm² treatment in people with Alzheimer's disease (MMSE 10-26) initiating...
The purpose of this study is to support the optimal use of rivastigmine patch in long-term treatment of AD in patients demonstrating cognitive decline at the target maintenance dose of riv...
Exelon Patch and Combination With Memantine Comparative Trial
The primary objective is to compare the tolerability between rivastigmine patch monotherapy and combination therapy with memantine in patients with Alzheimer's disease (AD). The secondary...
PubMed Articles
Aim: The cholinesterase inhibitor rivastigmine is available in both oral and transdermal forms. The efficacy of oral rivastigmine appears to be dose-dependent. The current analysis investigates the...
Impact of rivastigmine patch and capsules on activities of daily living in Alzheimer's disease.
Background: Rivastigmine patches provide similar efficacy to rivastigmine capsules with a lower incidence of gastrointestinal side effects in patients with probable Alzheimer's disease (AD). Methods:...
Abstract Background: Two sizes of rivastigmine patch (5 cm(2) and 10 cm 2 ) are currently approved in the US and Europe, while a 20 cm 2 rivastigmine patch has also been tested. A 15 cm 2 riva...
Abstract Objective: To compare the tolerability and efficacy of combination therapy of memantine plus rivastigmine patch with rivastigmine patch monotherapy in patients with mild to moderate Alzheimer...
OBJECTIVE: Assess long-term cost-effectiveness of rivastigmine patch in Alzheimer's disease (AD) management in the UK, using cognitive and functional models based on clinical trial efficacy data. METH...
