CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 583 enrolled
Drug / intervention
Rivastigmine capsule +1 moredrug
Likely dose
Rivastigmine capsule 12 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/NCT00623103
NCT00623103Phase 3Completed
CompareCT.gov

A 76-week Prospective, Open-label, Multicenter Study to Evaluate the Long-term Effect of Rivastigmine Capsule and Transdermal Patch on Worsening of the Underlying Motor Symptoms of PD in Patients With Mild to Moderately Severe Dementia Associated With Parkinson's Disease (PDD)

Novartis·interventional·Posted Feb 25, 2008·Updated Nov 28, 2011

In Brief

A Phase 3 clinical trial evaluating Rivastigmine capsule and Rivastigmine transdermal patch for Parkinson's Disease Dementia. Completed, enrolled 583 participants across 127 sites in 13 countries.

Detailed Summary

The purpose of this study is to provide long-term safety data for rivastigmine capsule and transdermal patch treatments, in particular the effect of rivastigmine on worsening of the underlying motor symptoms of Parkinson's Disease (PD), in patients with mild to moderately severe dementia associated with PD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson's Disease Dementia
CountriesArgentina, Australia, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, Spain, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 25, 2008
Enrollment StartJan 1, 2008
Primary CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 18.4 years ago

Interventions

Rivastigmine capsuledrug

Rivastigmine capsules orally twice a day. Target dose 12 mg/day.

Rivastigmine transdermal patchdrug

Rivastigmine patch once a day in the morning, worn for 24 hours. Target dose 10 cm\^2/day delivering 9.5 mg over a 24 hour period.