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Convenience, Tolerability, and Safety of Change in the Administration of Rivastigmine From Capsules to a Transdermal Patch in Patients With Mild to Moderate Alzheimer's Disease

NCT00549601 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2011-03-24

Study results available
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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.

Conditions

Interventions

DRUG

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

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).

DRUG

Rivastigmine patch (9.5 mg/day)

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

DRUG

Rivastigmine capsules (6 mg to 12 mg/day)

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.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals, MD · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2009-04-30
Completion
2009-04-30

Countries

  • Spain

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00549601 on ClinicalTrials.gov