NCT00234637
Completed
Phase 4
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
ConditionsAlzheimer's Disease
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Alzheimer's Disease
- Sponsor
- Novartis
- Enrollment
- 204
- Locations
- 1
- Primary Endpoint
- The proportion of responders (cognitive function stable or improved) at the end of phase 2 (vs. end of phase 1).
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
The proportion of responders (cognitive function stable or improved) at the end of phase 2 (vs. end of phase 1).
Secondary Outcomes
- 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
Study Sites (1)
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