Clinical trial NCT01025466: Exelon Patch and Combination With Memantine Comparative Trial
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alzheimer's Disease
Lead sponsor: Inha University Hospital
Sponsor class: OTHER
First posted: 2009-12-03
Enrollment: 206
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Retention rate at week 16 after randomization
timeFrame: End point (16 weeks after randomization)
Secondary outcomes:
measure: Change from baseline at week 16 in Alzheimer's Disease Assessment Scale-Cognitive subscale
timeFrame: 16 weeks after randomization
measure: Change from baseline at week 16 in Mini-Mental State Examination
timeFrame: 16 weeks after randomization
measure: Change from baseline at week 16 in Frontal Assessment Battery
timeFrame: 16 weeks after randomization
measure: Change from baseline at week 16 in Alzheimer's Disease Cooperative Study - Activities of Daily Living
timeFrame: 16 weeks after randomization
measure: Change from baseline at week 16 in Caregiver-Administered Neuropsychiatric Inventory
timeFrame: 16 weeks after randomization
measure: Change from baseline at week 16 in Cohen Mansfield Agitation Inventory
timeFrame: 16 weeks after randomization
measure: Change from baseline at week 16 in Clinical Dementia Rating Scale-Sum of Boxes
timeFrame: 16 weeks after randomization
measure: Safety
timeFrame: from baseline to end-point
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Soonchunhyang University Hospital
city: Bucheon
country: Korea, Republic of
facility: The Catholic University of Korea Hospital
city: Busan
country: Korea, Republic of
facility: Donga University Hospital
city: Changwon
country: Korea, Republic of
facility: Changwon Fatima Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daejun
country: Korea, Republic of
facility: Daejun Eulji University Hopistal
city: Goyang
country: Korea, Republic of
facility: Dongguk University Medical Center
city: Goyang
country: Korea, Republic of
facility: Myongji Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Iksan
country: Korea, Republic of
facility: Wonkwang University Hospital
city: Incheon
country: Korea, Republic of
facility: Inha Univeristy Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Pusan
country: Korea, Republic of
facility: Maryknoll Hospital
city: Seongnam
country: Korea, Republic of
facility: Bobath Memorial Hospital
city: Seoul
country: Korea, Republic of
facility: Kyughee University Medical Center
city: Seoul
country: Korea, Republic of
facility: Kangdong Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Sungkyunkwan University, Samsung Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk University Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul Eulji Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Boramae Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
Study officials:
affiliation: Department of Neurology, Inha University Hospital
name: Seong Choi, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.