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Exelon Patch and Combination With Memantine Comparative Trial

NCT01025466 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 206

Last updated 2010-05-19

No results posted yet for this study

Summary

The primary objective is to compare the tolerability between rivastigmine patch monotherapy and combination therapy with memantine in patients with Alzheimer's disease (AD). The secondary objective is to compare the efficacy and safety between rivastigmine patch monotherapy and combination therapy with memantine in patients with AD. The study hypothesis is that the tolerability of the combination therapy with memantine is not inferior to that of rivastigmine patch monotherapy in AD patients.

Conditions

Interventions

DRUG

Rivastigmine transdermal patch (Exelon patch), memantine

All patients start on a 5-cm2 rivastigmine patch and their dose is increased to a 10-cm2 patch after 4 weeks. Patients will be randomly allocated to 1 of 2 treatment groups of rivastigmine patch monotherapy and combination therapy with memantine at the baseline visit (week 9)and treated with the drugs for 16 weeks.

DRUG

Rivastigmine transdermal patch

All patients start on a 5-cm2 rivastigmine patch and their dose is increased to a 10-cm2 patch after 4 weeks. Patients will be randomly allocated to 1 of 2 treatment groups of rivastigmine patch monotherapy and combination therapy with memantine at the baseline visit (week 9)and treated with the drugs for 16 weeks.

Sponsors & Collaborators

  • Inha University Hospital

    lead OTHER

Principal Investigators

  • Seong Choi, MD · Department of Neurology, Inha University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2009-11-30
Completion
2010-04-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

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 NCT01025466 on ClinicalTrials.gov