Exelon Patch and Combination With Memantine Comparative Trial (EXPECT)

This study has been completed.
Sponsor:
Information provided by:
Inha University Hospital
ClinicalTrials.gov Identifier:
NCT01025466
First received: December 2, 2009
Last updated: May 18, 2010
Last verified: May 2010

December 2, 2009
May 18, 2010
December 2008
November 2009   (final data collection date for primary outcome measure)
Retention rate at week 16 after randomization [ Time Frame: End point (16 weeks after randomization) ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01025466 on ClinicalTrials.gov Archive Site
  • Change from baseline at week 16 in Alzheimer's Disease Assessment Scale-Cognitive subscale [ Time Frame: 16 weeks after randomization ] [ Designated as safety issue: No ]
  • Change from baseline at week 16 in Mini-Mental State Examination [ Time Frame: 16 weeks after randomization ] [ Designated as safety issue: No ]
  • Change from baseline at week 16 in Frontal Assessment Battery [ Time Frame: 16 weeks after randomization ] [ Designated as safety issue: No ]
  • Change from baseline at week 16 in Alzheimer's Disease Cooperative Study - Activities of Daily Living [ Time Frame: 16 weeks after randomization ] [ Designated as safety issue: No ]
  • Change from baseline at week 16 in Caregiver-Administered Neuropsychiatric Inventory [ Time Frame: 16 weeks after randomization ] [ Designated as safety issue: No ]
  • Change from baseline at week 16 in Cohen Mansfield Agitation Inventory [ Time Frame: 16 weeks after randomization ] [ Designated as safety issue: No ]
  • Change from baseline at week 16 in Clinical Dementia Rating Scale-Sum of Boxes [ Time Frame: 16 weeks after randomization ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: from baseline to end-point ] [ Designated as safety issue: Yes ]
ADAS-cog, Frontal Assessment Battery, NPI, Cohen-Mansfield Agitation Inventory, MMSE, CDR-Sum of Boxes, ADCS-ADL, adverse events [ Time Frame: 16 weeks after randomization ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Exelon Patch and Combination With Memantine Comparative Trial
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Alzheimer's Disease
  • 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.
    Other Name: exelon patch, ebixa
  • Drug: 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.
    Other Name: exelon patch
  • Active Comparator: rivastigmine patch monotherapy
    Intervention: Drug: Rivastigmine transdermal patch
  • Active Comparator: Combination therapy with memantine
    Intervention: Drug: Rivastigmine transdermal patch (Exelon patch), memantine
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
206
April 2010
November 2009   (final data collection date for primary outcome measure)

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
Both
50 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01025466
EXPECT
Yes
Seong Hye Choi, Inha University Hospital
Inha University Hospital
Not Provided
Principal Investigator: Seong Choi, MD Department of Neurology, Inha University Hospital
Inha University Hospital
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP