CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 859 enrolled
Drug / intervention
Rivastigmine transdermal patch +1 moredrug
Likely dose
Rivastigmine transdermal patch 4.5 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/NCT00423085
NCT00423085Phase 3Completed

A 24-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-finding Evaluation of the Efficacy, Safety, and Tolerability of the Once-daily Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease (MMSE 10-20)

Novartis Pharmaceuticals·interventional·Posted Jan 17, 2007·Updated Feb 10, 2014

In Brief

A Phase 3 clinical trial evaluating Rivastigmine transdermal patch and Placebo for Alzheimer's Disease. Completed, enrolled 859 participants across 1 site.

Detailed Summary

The purpose of this study was to investigate the 5cm\^2 and 10cm\^2 doses of rivastigmine transdermal patch in terms of efficacy and safety in patients with probable Alzheimer's Disease (MMSE \[Mini Mental State Examination\] 10-20). A 52-week extension phase evaluated the safety and tolerability of long-term treatment by rivastigmine transdermal patch in patients with probable Alzheimer's Disease (AD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 17, 2007
Enrollment StartJan 1, 2007
Primary CompletionMar 1, 2009
Study CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 19.5 years ago

Interventions

Rivastigmine transdermal patchdrug

Rivastigmine transdermal patch was provided in the following sizes and doses: 2.5 cm\^2 (4.5 mg), 5 cm\^2 (9 mg), 7.5 cm\^2 (13.5 mg), and 10 cm\^2 (18 mg). The caregiver applied one patch on the back of a patient, placed alternately from the right to the left side at approximately the same time each day.

Placebodrug

Placebo transdermal patch was provided in the following sizes: 2.5 cm\^2, 5 cm\^2, 7.5 cm\^2 and 10 cm\^2. The caregiver applied one patch on the back of a patient, placed alternately from the right to the left side at approximately the same time each day.