Exelon Patch and Combination With Memantine Comparative Trial

Alzheimer's Disease Clinical Trial

— EXPECT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01025466
• Other study ID #: EXPECT
• Status: Completed
• Phase: Phase 4
• First received: December 2, 2009
• Last updated: May 18, 2010
• Start date: December 2008
• Est. completion date: April 2010

Study information

• Verified date: May 2010
• Source: Inha University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: April 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Soonchunhyang University Hospital	Bucheon
Korea, Republic of	The Catholic University of Korea Hospital	Bucheon
Korea, Republic of	Donga University Hospital	Busan
Korea, Republic of	Changwon Fatima Hospital	Changwon
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Daejun Eulji University Hopistal	Daejun
Korea, Republic of	Dongguk University Medical Center	Goyang
Korea, Republic of	Myongji Hospital	Goyang
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Wonkwang University Hospital	Iksan
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Inha Univeristy Hospital	Incheon
Korea, Republic of	Maryknoll Hospital	Pusan
Korea, Republic of	Pusan National University Hospital	Pusan
Korea, Republic of	Bobath Memorial Hospital	Seongnam
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Ewha Womans University Hospital	Seoul
Korea, Republic of	Hallym University Hospital	Seoul
Korea, Republic of	Kangdong Sacred Heart Hospital	Seoul
Korea, Republic of	Konkuk University Hospital	Seoul
Korea, Republic of	Kyughee University Medical Center	Seoul
Korea, Republic of	Seoul Eulji Hospital	Seoul
Korea, Republic of	Seoul Medical Center	Seoul
Korea, Republic of	Seoul National University Boramae Hospital	Seoul
Korea, Republic of	Sungkyunkwan University, Samsung Seoul Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
Inha University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention rate at week 16 after randomization		End point (16 weeks after randomization)	Yes
Secondary	Change from baseline at week 16 in Alzheimer's Disease Assessment Scale-Cognitive subscale		16 weeks after randomization	No
Secondary	Change from baseline at week 16 in Mini-Mental State Examination		16 weeks after randomization	No
Secondary	Change from baseline at week 16 in Frontal Assessment Battery		16 weeks after randomization	No
Secondary	Change from baseline at week 16 in Alzheimer's Disease Cooperative Study - Activities of Daily Living		16 weeks after randomization	No
Secondary	Change from baseline at week 16 in Caregiver-Administered Neuropsychiatric Inventory		16 weeks after randomization	No
Secondary	Change from baseline at week 16 in Cohen Mansfield Agitation Inventory		16 weeks after randomization	No
Secondary	Change from baseline at week 16 in Clinical Dementia Rating Scale-Sum of Boxes		16 weeks after randomization	No
Secondary	Safety		from baseline to end-point	Yes