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Exelon Patch and Combination With Memantine Comparative Trial (EXPECT)

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Rivastigmine transdermal patch (Exelon patch), memantine
Rivastigmine transdermal patch
Sponsored by
Inha University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Soonchunhyang University Hospital
  • The Catholic University of Korea Hospital
  • Donga University Hospital
  • Changwon Fatima Hospital
  • Keimyung University Dongsan Medical Center
  • Daejun Eulji University Hopistal
  • Dongguk University Medical Center
  • Myongji Hospital
  • Chonnam National University Hospital
  • Wonkwang University Hospital
  • Inha Univeristy Hospital
  • Gachon University Gil Medical Center
  • Pusan National University Hospital
  • Maryknoll Hospital
  • Bobath Memorial Hospital
  • Kyughee University Medical Center
  • Kangdong Sacred Heart Hospital
  • Sungkyunkwan University, Samsung Seoul Hospital
  • Konkuk University Hospital
  • Hallym University Hospital
  • Ewha Womans University Hospital
  • Asan Medical Center
  • Seoul Eulji Hospital
  • Seoul Medical Center
  • Seoul National University Boramae Hospital
  • Ajou University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

rivastigmine patch monotherapy

Combination therapy with memantine

Arm Description

Outcomes

Primary Outcome Measures

Retention rate at week 16 after randomization

Secondary Outcome Measures

Change from baseline at week 16 in Alzheimer's Disease Assessment Scale-Cognitive subscale
Change from baseline at week 16 in Mini-Mental State Examination
Change from baseline at week 16 in Frontal Assessment Battery
Change from baseline at week 16 in Alzheimer's Disease Cooperative Study - Activities of Daily Living
Change from baseline at week 16 in Caregiver-Administered Neuropsychiatric Inventory
Change from baseline at week 16 in Cohen Mansfield Agitation Inventory
Change from baseline at week 16 in Clinical Dementia Rating Scale-Sum of Boxes
Safety

Full Information

First Posted
December 2, 2009
Last Updated
May 18, 2010
Sponsor
Inha University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01025466
Brief Title
Exelon Patch and Combination With Memantine Comparative Trial
Acronym
EXPECT
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Inha University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
206 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rivastigmine patch monotherapy
Arm Type
Active Comparator
Arm Title
Combination therapy with memantine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Rivastigmine transdermal patch (Exelon patch), memantine
Other Intervention Name(s)
exelon patch, ebixa
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Rivastigmine transdermal patch
Other Intervention Name(s)
exelon patch
Intervention Description
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.
Primary Outcome Measure Information:
Title
Retention rate at week 16 after randomization
Time Frame
End point (16 weeks after randomization)
Secondary Outcome Measure Information:
Title
Change from baseline at week 16 in Alzheimer's Disease Assessment Scale-Cognitive subscale
Time Frame
16 weeks after randomization
Title
Change from baseline at week 16 in Mini-Mental State Examination
Time Frame
16 weeks after randomization
Title
Change from baseline at week 16 in Frontal Assessment Battery
Time Frame
16 weeks after randomization
Title
Change from baseline at week 16 in Alzheimer's Disease Cooperative Study - Activities of Daily Living
Time Frame
16 weeks after randomization
Title
Change from baseline at week 16 in Caregiver-Administered Neuropsychiatric Inventory
Time Frame
16 weeks after randomization
Title
Change from baseline at week 16 in Cohen Mansfield Agitation Inventory
Time Frame
16 weeks after randomization
Title
Change from baseline at week 16 in Clinical Dementia Rating Scale-Sum of Boxes
Time Frame
16 weeks after randomization
Title
Safety
Time Frame
from baseline to end-point

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seong Choi, MD
Organizational Affiliation
Department of Neurology, Inha University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soonchunhyang University Hospital
City
Bucheon
ZIP/Postal Code
420-767
Country
Korea, Republic of
Facility Name
The Catholic University of Korea Hospital
City
Bucheon
Country
Korea, Republic of
Facility Name
Donga University Hospital
City
Busan
ZIP/Postal Code
602-715
Country
Korea, Republic of
Facility Name
Changwon Fatima Hospital
City
Changwon
ZIP/Postal Code
641-560
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
ZIP/Postal Code
700-712
Country
Korea, Republic of
Facility Name
Daejun Eulji University Hopistal
City
Daejun
ZIP/Postal Code
302-799
Country
Korea, Republic of
Facility Name
Dongguk University Medical Center
City
Goyang
ZIP/Postal Code
41-773
Country
Korea, Republic of
Facility Name
Myongji Hospital
City
Goyang
ZIP/Postal Code
412-270
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju
ZIP/Postal Code
501-757
Country
Korea, Republic of
Facility Name
Wonkwang University Hospital
City
Iksan
ZIP/Postal Code
570-180
Country
Korea, Republic of
Facility Name
Inha Univeristy Hospital
City
Incheon
ZIP/Postal Code
400-711
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
405-760
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Pusan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Facility Name
Maryknoll Hospital
City
Pusan
Country
Korea, Republic of
Facility Name
Bobath Memorial Hospital
City
Seongnam
Country
Korea, Republic of
Facility Name
Kyughee University Medical Center
City
Seoul
ZIP/Postal Code
130-702
Country
Korea, Republic of
Facility Name
Kangdong Sacred Heart Hospital
City
Seoul
ZIP/Postal Code
134-701
Country
Korea, Republic of
Facility Name
Sungkyunkwan University, Samsung Seoul Hospital
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Konkuk University Hospital
City
Seoul
ZIP/Postal Code
143-729
Country
Korea, Republic of
Facility Name
Hallym University Hospital
City
Seoul
ZIP/Postal Code
150-719
Country
Korea, Republic of
Facility Name
Ewha Womans University Hospital
City
Seoul
ZIP/Postal Code
158-710
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
431-060
Country
Korea, Republic of
Facility Name
Seoul Eulji Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Boramae Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Suwon
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
21561398
Citation
Choi SH, Park KW, Na DL, Han HJ, Kim EJ, Shim YS, Lee JH; Expect Study Group. Tolerability and efficacy of memantine add-on therapy to rivastigmine transdermal patches in mild to moderate Alzheimer's disease: a multicenter, randomized, open-label, parallel-group study. Curr Med Res Opin. 2011 Jul;27(7):1375-83. doi: 10.1185/03007995.2011.582484. Epub 2011 May 12.
Results Reference
derived

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Exelon Patch and Combination With Memantine Comparative Trial

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