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NCT Number: NCT01025466

Exelon Patch and Combination With Memantine Comparative Trial

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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Soonchunhyang University Hospital, Bucheon-si, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rivastigmine transdermal patch (Exelon patch), memantine

Drug

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 names: exelon patch, ebixa

Rivastigmine transdermal patch

Drug

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 names: exelon patch

Primary outcomes

  1. Retention rate at week 16 after randomization

    Time frame: End point (16 weeks after randomization)

Secondary outcomes

  1. Change from baseline at week 16 in Alzheimer's Disease Assessment Scale-Cognitive subscale

    Time frame: 16 weeks after randomization

  2. Change from baseline at week 16 in Mini-Mental State Examination

    Time frame: 16 weeks after randomization

  3. Change from baseline at week 16 in Frontal Assessment Battery

    Time frame: 16 weeks after randomization

  4. Change from baseline at week 16 in Alzheimer's Disease Cooperative Study - Activities of Daily Living

    Time frame: 16 weeks after randomization

  5. Change from baseline at week 16 in Caregiver-Administered Neuropsychiatric Inventory

    Time frame: 16 weeks after randomization

  6. Change from baseline at week 16 in Cohen Mansfield Agitation Inventory

    Time frame: 16 weeks after randomization

  7. Change from baseline at week 16 in Clinical Dementia Rating Scale-Sum of Boxes

    Time frame: 16 weeks after randomization

  8. Safety

    Time frame: from baseline to end-point

Sponsors and collaborators

Lead sponsor

Inha University Hospital

Other

Registry information

Official study 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

Acronym: EXPECT

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Dec 3, 2009
Registry last updated
May 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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