Alzheimer's DiseasePhase 4EXPECTNCT01025466
Exelon Patch and Combination With Memantine Comparative Trial
A Phase 4 study testing Rivastigmine transdermal patch (Exelon patch), memantine and Rivastigmine transdermal patch in people with Alzheimer's Disease, run by Inha University Hospital at 26 sites in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Rivastigmine transdermal patch (Exelon patch), memantine and Rivastigmine transdermal patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 26 sitesSouth Korea
- Study dates
- Dec 2008to Apr 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
South Korea26 sites
Soonchunhyang University Hospital
Bucheon-si, 420-767
The Catholic University of Korea Hospital
Bucheon-si
Donga University Hospital
Busan, 602-715
Changwon Fatima Hospital
Changwon, 641-560
Keimyung University Dongsan Medical Center
Daegu, 700-712
Daejun Eulji University Hopistal
Daejun, 302-799
Dongguk University Medical Center
Goyang, 41-773
Myongji Hospital
Goyang, 412-270
Chonnam National University Hospital
Gwangju, 501-757
Wonkwang University Hospital
Iksan, 570-180
Inha Univeristy Hospital
Incheon, 400-711
Gachon University Gil Medical Center
Incheon, 405-760
Pusan National University Hospital
Pusan, 602-739
Maryknoll Hospital
Pusan
Bobath Memorial Hospital
Seongnam
Kyughee University Medical Center
Seoul, 130-702
Kangdong Sacred Heart Hospital
Seoul, 134-701
Sungkyunkwan University, Samsung Seoul Hospital
Seoul, 135-710
Konkuk University Hospital
Seoul, 143-729
Hallym University Hospital
Seoul, 150-719
Ewha Womans University Hospital
Seoul, 158-710
Asan Medical Center
Seoul, 431-060
Seoul Eulji Hospital
Seoul
Seoul Medical Center
Seoul
Seoul National University Boramae Hospital
Seoul
Ajou University Hospital
Suwon
About this study
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
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.
Read the 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
- Being tested
- Rivastigmine transdermal patch (Exelon patch), memantine, Rivastigmine transdermal patch
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivastigmine transdermal patch (Exelon patch), memantineDrug
Also called exelon patch, ebixa
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.
Rivastigmine transdermal patchDrug
Also called exelon 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.
| Study group | Role | What they receive |
|---|---|---|
| rivastigmine patch monotherapy | Active comparator | Not described Receives: Drug: Rivastigmine transdermal patch |
| Combination therapy with memantine | Active comparator | Not described Receives: Drug: Rivastigmine transdermal patch (Exelon patch), memantine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention rate at week 16 after randomization
Measured: End point (16 weeks after randomization)
Secondary outcomes (8)
Change from baseline at week 16 in Alzheimer's Disease Assessment Scale-Cognitive subscale
Measured: 16 weeks after randomization
Change from baseline at week 16 in Mini-Mental State Examination
Measured: 16 weeks after randomization
Change from baseline at week 16 in Frontal Assessment Battery
Measured: 16 weeks after randomization
Change from baseline at week 16 in Alzheimer's Disease Cooperative Study - Activities of Daily Living
Measured: 16 weeks after randomization
Change from baseline at week 16 in Caregiver-Administered Neuropsychiatric Inventory
Measured: 16 weeks after randomization
Change from baseline at week 16 in Cohen Mansfield Agitation Inventory
Measured: 16 weeks after randomization
Change from baseline at week 16 in Clinical Dementia Rating Scale-Sum of Boxes
Measured: 16 weeks after randomization
Safety
Measured: from baseline to end-point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2009 (estimated)
- Study startDec 2008
- Primary completionNov 2009
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inha University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Seong Choi, MD, Principal investigator, Department of Neurology, Inha University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01025466
- Sponsor's protocol ID
- EXPECT
- Acronym
- EXPECT
- Status last verified
- May 2010
- First submitted
- 2 Dec 2009
- Last updated
- 19 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21561398
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01025466
- Acronym / sponsor ID
- EXPECT / EXPECT
- Conditions
- Alzheimer's Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Inha University HospitalUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 3 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rivastigmine patch monotherapy | Active comparator | Drug: Rivastigmine transdermal patch |
| Combination therapy with memantine | Active comparator | Drug: Rivastigmine transdermal patch (Exelon patch), memantine |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rivastigmine transdermal patch (Exelon patch), memantineAlso: exelon patch, ebixaAll 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. | Drug | Combination therapy with memantine |
| Rivastigmine transdermal patchAlso: exelon patchAll 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. | Drug | rivastigmine patch monotherapy |
Primary outcome
Retention rate at week 16 after randomization
Time frame: End point (16 weeks after randomization)
8 secondary outcomes
Change from baseline at week 16 in Alzheimer's Disease Assessment Scale-Cognitive subscale
Time frame: 16 weeks after randomization
Change from baseline at week 16 in Mini-Mental State Examination
Time frame: 16 weeks after randomization
Change from baseline at week 16 in Frontal Assessment Battery
Time frame: 16 weeks after randomization
Change from baseline at week 16 in Alzheimer's Disease Cooperative Study - Activities of Daily Living
Time frame: 16 weeks after randomization
Change from baseline at week 16 in Caregiver-Administered Neuropsychiatric Inventory
Time frame: 16 weeks after randomization
Change from baseline at week 16 in Cohen Mansfield Agitation Inventory
Time frame: 16 weeks after randomization
Change from baseline at week 16 in Clinical Dementia Rating Scale-Sum of Boxes
Time frame: 16 weeks after randomization
Safety
Time frame: from baseline to end-point
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2010.
- Derived from this study: PubMed 21561398Choi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seong Choi, MD principal investigator
Department of Neurology, Inha University Hospital
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rivastigmine transdermal patch (Exelon patch), memantine and Rivastigmine transdermal patch in people with Alzheimer's Disease, run by Inha University Hospital at 26 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention rate at week 16 after randomization (time frame: End point (16 weeks after randomization)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01025466, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2010.