At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 142 enrolled

Drug / intervention

Rivastigmine patch (4.6 mg/day switch to 9.5 mg/day) +2 moredrug

Likely dose

Rivastigmine patch (4.6 mg/day switch to 9.5 mg/day)from 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/NCT00549601

NCT00549601Phase 4Completed

Compare CT.gov

A Multi-center, Randomised, Open-label Study to Evaluate Convenience and Safety of Change in the Mode of Administration of Rivastigmine (From Capsules to a Transdermal Patch) in Patients With Alzheimer's Disease

Novartis·interventional·Posted Oct 26, 2007·Updated Mar 24, 2011

In Brief

A Phase 4 clinical trial evaluating Rivastigmine patch (4.6 mg/day switch to 9.5 mg/day), Rivastigmine patch (9.5 mg/day), and 1 other intervention for Alzheimer's Disease. Completed, enrolled 142 participants across 1 site.

Detailed Summary

This study used two doses of rivastigmine transdermal patch (5 cm\^2, 10 cm\^2) to establish the feasibility of 2 switch schedules (with transdermal patch one-step dose titration or without dose titration) from rivastigmine capsules (3 mg bid (bis in die, twice a day), 4,5 mg bid, 6 mg bid) to rivastigmine transdermal patch and to assess safety, tolerability, convenience, and caregivers preferences of rivastigmine transdermal patch versus capsules.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsAlzheimer's Disease

CountriesSpain

Collaborators--

Timeline

Phase 4CompletedFinished

20082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartSep 2007

First PostedOct 2007

Primary CompletionApr 2009

TodayJul 2026

First PostedOct 26, 2007

Enrollment StartSep 1, 2007

Primary CompletionApr 1, 2009

TodayJul 2, 2026

Enrollment to primary: 1.6 yearsPosted 18.7 years ago

Interventions

Rivastigmine patch (4.6 mg/day switch to 9.5 mg/day)drug

Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months).

Rivastigmine patch (9.5 mg/day)drug

Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment).

Rivastigmine capsules (6 mg to 12 mg/day)drug

Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment.