Back to resultsRivastigmine Monotherapy and Combination Therapy With Memantine in Patients With Moderately Severe Alzheimer's Disease Who Failed to Benefit From Previous Cholinesterase Inhibitor Treatment
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Rivastigmine, memantine
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's disease,, switch,, rivastigmine,, memantine
Eligibility Criteria
Inclusion Criteria: Outpatients who have probable Alzheimer's disease according to the DSMIV criteria Patients treated with donepezil (5-10 mg ) or galantamine (16- 24 mg) for at least 6 months Patients, in the investigator's clinical judgment, not stabilized on treatment with donepezil or galantamine Exclusion Criteria: Patients with evidence of severe or unstable physical illness, i.e., acute and severe asthmatic conditions, severe or unstable cardiovascular disorders, active peptic ulcer disease, hypersensitivity to cholinesterase inhibitors or memantine, clinically significant laboratory abnormalities or any patient with a medical condition which would prohibit them from completing the clinical trial
Sites / Locations
- Département de Gérontologie Clinique
Outcomes
Primary Outcome Measures
The proportion of responders (cognitive function stable or improved) at the end of phase 2 (vs. end of phase 1).
Secondary Outcome Measures
Change in cognition at weeks 16 and 28 (end of period 1) compared to baseline
Change in caregiver burden at weeks 16 and 28 (end of period 1) compared to baseline
Change in behavior at weeks 16 and 28 (end of period 1) compared to baseline
Change in executive function at weeks 16 and 28 (end of period 1) compared to baseline
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00234637
Brief Title
Rivastigmine Monotherapy and Combination Therapy With Memantine in Patients With Moderately Severe Alzheimer's Disease Who Failed to Benefit From Previous Cholinesterase Inhibitor Treatment
Official Title
An Open-label Study to Evaluate the Efficacy and Safety of add-on Memantine [5-10 mg b.i.d (10-20 mg/Day)] to Rivastigmine [1.5-6 mg b.i.d. (3-12 mg/Day)] Treatment in Patients With Alzheimer's Disease Who Continued With Rivastigmine Treatment After a Previous Decline While on Donepezil or Galantamine Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
This is a prospective, multicenter, open-label study. Following screening and baseline assessments, eligible patients will be switched to rivastigmine and will enter the 16 week run-in rivastigmine treatment phase. After completion of assessments at the end of the run-in phase, patients who were not sufficiently stabilized on rivastigmine alone will receive add-on memantine to their rivastigmine treatment; patients who were stabilized on rivastigmine alone will have completed and be discontinued from the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer's disease,, switch,, rivastigmine,, memantine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
204 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Rivastigmine, memantine
Primary Outcome Measure Information:
Title
The proportion of responders (cognitive function stable or improved) at the end of phase 2 (vs. end of phase 1).
Secondary Outcome Measure Information:
Title
Change in cognition at weeks 16 and 28 (end of period 1) compared to baseline
Title
Change in caregiver burden at weeks 16 and 28 (end of period 1) compared to baseline
Title
Change in behavior at weeks 16 and 28 (end of period 1) compared to baseline
Title
Change in executive function at weeks 16 and 28 (end of period 1) compared to baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Outpatients who have probable Alzheimer's disease according to the DSMIV criteria
Patients treated with donepezil (5-10 mg ) or galantamine (16- 24 mg) for at least 6 months
Patients, in the investigator's clinical judgment, not stabilized on treatment with donepezil or galantamine
Exclusion Criteria:
Patients with evidence of severe or unstable physical illness, i.e., acute and severe asthmatic conditions, severe or unstable cardiovascular disorders, active peptic ulcer disease, hypersensitivity to cholinesterase inhibitors or memantine, clinically significant laboratory abnormalities or any patient with a medical condition which would prohibit them from completing the clinical trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry Dantoine
Organizational Affiliation
Centre Hospitalier Universitaire
Official's Role
Principal Investigator
Facility Information:
Facility Name
Département de Gérontologie Clinique
City
Limoges
State/Province
Cedex
ZIP/Postal Code
87042
Country
France
12. IPD Sharing Statement
Learn more about this trial
Rivastigmine Monotherapy and Combination Therapy With Memantine in Patients With Moderately Severe Alzheimer's Disease Who Failed to Benefit From Previous Cholinesterase Inhibitor Treatment
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