Exelon Patch and Combination With Memantine Comparative Trial (EXPECT)

May 18, 2010 updated by: Inha University Hospital

A Multicenter, Randomized, Open-label Study to Compare the Tolerability Between Rivastigmine Patch Monotherapy and Combination Therapy With Memantine in Patients With Alzheimer's Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Recently, the rivastigmine patch demonstrated efficacy comparable to the highest doses of rivastigmine capsules, with markedly improved tolerability profile. We hypothesized that combination of memantine and rivastigmine patch will be safe and well tolerated and result in more clinical benefit in patients with AD in comparison with rivastigmine patch monotherapy, for the mechanisms of the drugs are different.

Study Type

Interventional

Enrollment (Actual)

206

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Bucheon, Korea, Republic of, 420-767
        • Soonchunhyang University Hospital
      • Bucheon, Korea, Republic of
        • The Catholic University of Korea Hospital
      • Busan, Korea, Republic of, 602-715
        • DongA University Hospital
      • Changwon, Korea, Republic of, 641-560
        • Changwon Fatima Hospital
      • Daegu, Korea, Republic of, 700-712
        • Keimyung University Dongsan Medical Center
      • Daejun, Korea, Republic of, 302-799
        • Daejun Eulji University Hopistal
      • Goyang, Korea, Republic of, 41-773
        • Dongguk University Medical Center
      • Goyang, Korea, Republic of, 412-270
        • Myongji Hospital
      • Gwangju, Korea, Republic of, 501-757
        • Chonnam National University Hospital
      • Iksan, Korea, Republic of, 570-180
        • Wonkwang University Hospital
      • Incheon, Korea, Republic of, 405-760
        • Gachon University Gil Medical Center
      • Incheon, Korea, Republic of, 400-711
        • Inha Univeristy Hospital
      • Pusan, Korea, Republic of, 602-739
        • Pusan National University Hospital
      • Pusan, Korea, Republic of
        • Maryknoll Hospital
      • Seongnam, Korea, Republic of
        • Bobath Memorial Hospital
      • Seoul, Korea, Republic of
        • Seoul National University Boramae Hospital
      • Seoul, Korea, Republic of
        • Seoul Medical Center
      • Seoul, Korea, Republic of, 143-729
        • Konkuk University Hospital
      • Seoul, Korea, Republic of, 134-701
        • Kangdong Sacred Heart Hospital
      • Seoul, Korea, Republic of, 130-702
        • Kyughee University Medical Center
      • Seoul, Korea, Republic of, 135-710
        • Sungkyunkwan University, Samsung Seoul Hospital
      • Seoul, Korea, Republic of, 150-719
        • HALLYM UNIVERSITY HOSPITAL
      • Seoul, Korea, Republic of, 158-710
        • Ewha Womans University Hospital
      • Seoul, Korea, Republic of, 431-060
        • Asan Medical Center
      • Seoul, Korea, Republic of
        • Seoul Eulji Hospital
      • Suwon, Korea, Republic of
        • Ajou University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Dementia by DSM-IV and probable AD by NINCDS-ADRDA
  • Age of 50 to 90 years
  • Mini-Mental State Examination (MMSE) score of 10 to 20
  • Brain MRI or CT scan consistent with a diagnosis of probable AD
  • The caregiver must meet the patient at least once a week and be sufficiently familiar with the patient to provide accurate data.
  • Ambulatory or ambulatory-aided (is, walker or cane) ability
  • Written informed consent will be obtained from the patient (if possible) and from the patient's legally acceptable representative. Even if unable to provide written informed consent, the patient must assent verbally to participating in the study.

Exclusion Criteria:

  • Patients with evidence of severe or unstable physical illness, i.e., acute and severe asthmatic conditions, severe or unstable cardiovascular disease, active peptic ulcer disease, severe hepatic or renal disease, or any medical condition which would prohibit them from completing the study
  • Any psychiatric or primary neurodegenerative disorder other than AD
  • Any patients with hearing or visual problem that can disturb the efficient evaluation of the patients.
  • Any patients with a history of drug addiction or alcohol addiction for the past 10 years
  • Patients with bradycardia (bpm less than 50) or sick sinus syndrome or conduction defects (sino-atrial block, second ot third degree A-V blocks
  • Clinically significant laboratory abnormalities to affect cognitive function (i.e.abnormal thyroid function test, abnormal low level of vitamin B12 or folate, or syphilis, etc)
  • History of allergy to topical products containing any of the constitution of the patches
  • Current diagnosis of an active skin lesion
  • Involved in other clinical trials or treated by experimental drug within 4 weeks
  • Patients with hypersensitivity to cholinesterase inhibitors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: rivastigmine patch monotherapy
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.
Other Names:
  • exelon patch
Active Comparator: Combination therapy with memantine
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.
Other Names:
  • exelon patch, ebixa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Retention rate at week 16 after randomization
Time Frame: End point (16 weeks after randomization)
End point (16 weeks after randomization)

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline at week 16 in Alzheimer's Disease Assessment Scale-Cognitive subscale
Time Frame: 16 weeks after randomization
16 weeks after randomization
Change from baseline at week 16 in Mini-Mental State Examination
Time Frame: 16 weeks after randomization
16 weeks after randomization
Change from baseline at week 16 in Frontal Assessment Battery
Time Frame: 16 weeks after randomization
16 weeks after randomization
Change from baseline at week 16 in Alzheimer's Disease Cooperative Study - Activities of Daily Living
Time Frame: 16 weeks after randomization
16 weeks after randomization
Change from baseline at week 16 in Caregiver-Administered Neuropsychiatric Inventory
Time Frame: 16 weeks after randomization
16 weeks after randomization
Change from baseline at week 16 in Cohen Mansfield Agitation Inventory
Time Frame: 16 weeks after randomization
16 weeks after randomization
Change from baseline at week 16 in Clinical Dementia Rating Scale-Sum of Boxes
Time Frame: 16 weeks after randomization
16 weeks after randomization
Safety
Time Frame: from baseline to end-point
from baseline to end-point

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inha University Hospital

Investigators

  • Principal Investigator: Seong Choi, MD, Department of Neurology, Inha University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

December 2, 2009

First Submitted That Met QC Criteria

December 2, 2009

First Posted (Estimate)

December 3, 2009

Study Record Updates

Last Update Posted (Estimate)

May 19, 2010

Last Update Submitted That Met QC Criteria

May 18, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EXPECT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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