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Exelon Patch and Combination With Memantine Comparative Trial (EXPECT)

This study has been completed.
Sponsor:
Information provided by:
Inha University Hospital
ClinicalTrials.gov Identifier:
NCT01025466
First received: December 2, 2009
Last updated: May 18, 2010
Last verified: May 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
 Drug: Rivastigmine transdermal patch (Exelon patch), memantine
Drug: Rivastigmine transdermal patch
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Inha University Hospital:

Primary Outcome Measures:
  • Retention rate at week 16 after randomization [ Time Frame: End point (16 weeks after randomization) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline at week 16 in Alzheimer's Disease Assessment Scale-Cognitive subscale [ Time Frame: 16 weeks after randomization ] [ Designated as safety issue: No ]
  • Change from baseline at week 16 in Mini-Mental State Examination [ Time Frame: 16 weeks after randomization ] [ Designated as safety issue: No ]
  • Change from baseline at week 16 in Frontal Assessment Battery [ Time Frame: 16 weeks after randomization ] [ Designated as safety issue: No ]
  • Change from baseline at week 16 in Alzheimer's Disease Cooperative Study - Activities of Daily Living [ Time Frame: 16 weeks after randomization ] [ Designated as safety issue: No ]
  • Change from baseline at week 16 in Caregiver-Administered Neuropsychiatric Inventory [ Time Frame: 16 weeks after randomization ] [ Designated as safety issue: No ]
  • Change from baseline at week 16 in Cohen Mansfield Agitation Inventory [ Time Frame: 16 weeks after randomization ] [ Designated as safety issue: No ]
  • Change from baseline at week 16 in Clinical Dementia Rating Scale-Sum of Boxes [ Time Frame: 16 weeks after randomization ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: from baseline to end-point ] [ Designated as safety issue: Yes ]

Enrollment: 206
Study Start Date: December 2008
Study Completion Date: April 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: exelon patch, ebixa

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.

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01025466

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

No publications provided by Inha University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Seong Hye Choi, Inha University Hospital
ClinicalTrials.gov Identifier: NCT01025466     History of Changes
Other Study ID Numbers: EXPECT
Study First Received: December 2, 2009
Last Updated: May 18, 2010
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Memantine
Rivastigmine
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Cholinesterase Inhibitors
Enzyme Inhibitors
Cholinergic Agents
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on May 16, 2013