CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 501 enrolled
Drug / intervention
Rivastigmine Patch +3 moredrug
Likely dose
Rivastigmine Capsules 6 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01399125
NCT01399125Phase 3Completed
CompareCT.gov

A 24-Week, Randomized, Double-blind, Double-dummy, Parallel-group, Active-controlled Study to Assess the Efficacy, Safety, and Tolerability of the Once-daily Rivastigmine Patch Formulation in Patients With Probable Alzheimer's Disease (Mini-Mental State Examination (MMSE) 10-20)

Novartis Pharmaceuticals·interventional·Posted Jul 21, 2011·Updated Aug 4, 2014

In Brief

A Phase 3 clinical trial evaluating Rivastigmine Patch, Rivastigmine Capsules, and 2 other interventions for Alzheimer's Disease. Completed, enrolled 501 participants across 16 sites.

Detailed Summary

The purpose of this study is to assess the efficacy, safety, and tolerability of Exelon® patch in patients with probable AD (MMSE 10-20), in order to support a planned regulatory submission and registration of Exelon transdermal patch in China. The study is designed to confirm the non-inferiority of the efficacy of Exelon patch (target 10 cm² patch size) versus Exelon capsules (target 6.0 mg bid dose) on cognition, using the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer's Disease
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 21, 2011
Enrollment StartJul 1, 2011
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 14.9 years ago

Interventions

Rivastigmine Patchdrug

Once-daily target patch size 10 cm²

Rivastigmine Capsulesdrug

Twice-daily target dose of 6 mg oral capsule

Placebo to Rivastigmine patchdrug

Matching placebo to Rivastigmine patch

Placebo to Rivastigmine capsulesdrug

matching Placebo to Rivastigmine capsules