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Efficacy and Safety of Rivastigmine Transdermal Patch in Patients With Mild to Moderate Alzheimer's Disease

NCT00423085 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 859

Last updated 2014-02-10

Study results available
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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).

Conditions

Interventions

DRUG

Rivastigmine transdermal patch

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.

DRUG

Placebo

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.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2009-03-31
Completion
2010-04-30

Countries

  • Japan

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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 NCT00423085 on ClinicalTrials.gov