Exelon Patch and Combination With Memantine Comparative Trial

NCT01025466 | Completed Phase 4 DMC

• 1 other identifier: EXPECT
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 26

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.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• Retention rate at week 16 after randomization

  End point (16 weeks after randomization)

Secondary Outcomes (8)

• Change from baseline at week 16 in Alzheimer's Disease Assessment Scale-Cognitive subscale

  16 weeks after randomization

• Change from baseline at week 16 in Mini-Mental State Examination

  16 weeks after randomization

• Change from baseline at week 16 in Frontal Assessment Battery

  16 weeks after randomization

• Change from baseline at week 16 in Alzheimer's Disease Cooperative Study - Activities of Daily Living

  16 weeks after randomization

• Change from baseline at week 16 in Caregiver-Administered Neuropsychiatric Inventory

  16 weeks after randomization

Study Arms (2)

rivastigmine patch monotherapy

ACTIVE COMPARATOR

Drug: Rivastigmine transdermal patch

Combination therapy with memantine

ACTIVE COMPARATOR

Drug: Rivastigmine transdermal patch (Exelon patch), memantine

Interventions

Rivastigmine transdermal patch (Exelon patch), memantine 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.

Also known as: exelon patch, ebixa

Combination therapy with memantine

Rivastigmine transdermal patch 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.

Also known as: exelon patch

rivastigmine patch monotherapy

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Inha University Hospital: lead

Study Sites (26)

Soonchunhyang University Hospital

Bucheon-si, 420-767, South Korea

Location

The Catholic University of Korea Hospital

Bucheon-si, South Korea

Location

Donga University Hospital

Busan, 602-715, South Korea

Location

Changwon Fatima Hospital

Changwon, 641-560, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, 700-712, South Korea

Location

Daejun Eulji University Hopistal

Daejun, 302-799, South Korea

Location

Dongguk University Medical Center

Goyang, 41-773, South Korea

Location

Myongji Hospital

Goyang, 412-270, South Korea

Location

Chonnam National University Hospital

Gwangju, 501-757, South Korea

Location

Wonkwang University Hospital

Iksan, 570-180, South Korea

Location

Inha Univeristy Hospital

Incheon, 400-711, South Korea

Location

Gachon University Gil Medical Center

Incheon, 405-760, South Korea

Location

Pusan National University Hospital

Pusan, 602-739, South Korea

Location

Maryknoll Hospital

Pusan, South Korea

Location

Bobath Memorial Hospital

Seongnam, South Korea

Location

Kyughee University Medical Center

Seoul, 130-702, South Korea

Location

Kangdong Sacred Heart Hospital

Seoul, 134-701, South Korea

Location

Sungkyunkwan University, Samsung Seoul Hospital

Seoul, 135-710, South Korea

Location

Konkuk University Hospital

Seoul, 143-729, South Korea

Location

Hallym University Hospital

Seoul, 150-719, South Korea

Location

Ewha Womans University Hospital

Seoul, 158-710, South Korea

Location

Asan Medical Center

Seoul, 431-060, South Korea

Location

Seoul Eulji Hospital

Seoul, South Korea

Location

Seoul Medical Center

Seoul, South Korea

Location

Seoul National University Boramae Hospital

Seoul, South Korea

Location

Ajou University Hospital

Suwon, South Korea

Location

Related Publications (1)

• 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.

  PMID: 21561398 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Memantine

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Seong Choi, MD

  Department of Neurology, Inha University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 2, 2009
• First Posted: December 3, 2009
• Study Start: December 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: April 1, 2010
• Last Updated: May 19, 2010

Record last verified: 2010-05

Locations

KR (26)