Exelon Patch and Combination With Memantine Comparative Trial

NCT ID: NCT01025466

Last Updated: 2010-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 206 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2010-04-30

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.

Conditions

Alzheimer's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

rivastigmine patch monotherapy

Group Type: ACTIVE_COMPARATOR

Rivastigmine transdermal patch

Intervention Type: DRUG

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.

Combination therapy with memantine

Group Type: ACTIVE_COMPARATOR

Rivastigmine transdermal patch (Exelon patch), memantine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

exelon patch, ebixa; exelon patch

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Inha University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Inha University Hospital

Principal Investigators

Seong Choi, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, Inha University Hospital

Locations

Soonchunhyang University Hospital

Bucheon-si, , South Korea

The Catholic University of Korea Hospital

Bucheon-si, , South Korea

Donga University Hospital

Busan, , South Korea

Changwon Fatima Hospital

Changwon, , South Korea

Keimyung University Dongsan Medical Center

Daegu, , South Korea

Daejun Eulji University Hopistal

Daejun, , South Korea

Dongguk University Medical Center

Goyang, , South Korea

Myongji Hospital

Goyang, , South Korea

Chonnam National University Hospital

Gwangju, , South Korea

Wonkwang University Hospital

Iksan, , South Korea

Inha Univeristy Hospital

Incheon, , South Korea

Gachon University Gil Medical Center

Incheon, , South Korea

Pusan National University Hospital

Pusan, , South Korea

Maryknoll Hospital

Pusan, , South Korea

Bobath Memorial Hospital

Seongnam, , South Korea

Kyughee University Medical Center

Seoul, , South Korea

Kangdong Sacred Heart Hospital

Seoul, , South Korea

Sungkyunkwan University, Samsung Seoul Hospital

Seoul, , South Korea

Konkuk University Hospital

Seoul, , South Korea

Hallym University Hospital

Seoul, , South Korea

Ewha Womans University Hospital

Seoul, , South Korea

Asan Medical Center

Seoul, , South Korea

Seoul Eulji Hospital

Seoul, , South Korea

Seoul Medical Center

Seoul, , South Korea

Seoul National University Boramae Hospital

Seoul, , South Korea

Ajou University Hospital

Suwon, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 21561398 (View on PubMed)

Other Identifiers

EXPECT

Identifier Type: -

Identifier Source: org_study_id