Exelon Patch and Combination With Memantine Comparative Trial (EXPECT)

Inha University Hospital

Status and phase

Completed

Phase 4

Conditions

Alzheimer's Disease

Treatments

Drug: Rivastigmine transdermal patch

Drug: Rivastigmine transdermal patch (Exelon patch), memantine

Study type

Interventional

Funder types

Other

Identifiers

NCT01025466

EXPECT

Details and patient eligibility

About

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.

Full 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.

Enrollment

206 patients

Sex

All

Ages

50 to 90 years old

Volunteers

No Healthy Volunteers

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