Rivastigmine Monotherapy and Combination Therapy With Memantine in Patients With Moderately Severe Alzheimer's Disease Who Failed to Benefit From Previous Cholinesterase Inhibitor Treatment

Tracking Information
First Submitted Date ICMJE	October 5, 2005
First Posted Date ICMJE	October 7, 2005
Last Update Posted Date	November 17, 2011
Study Start Date ICMJE	November 2003
Actual Primary Completion Date	June 2005 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: May 30, 2006)	The proportion of responders (cognitive function stable or improved) at the end of phase 2 (vs. end of phase 1).
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00234637 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: May 30, 2006)	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
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	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 ICMJE	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
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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 4
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Alzheimer's Disease
Intervention ICMJE	Drug: Rivastigmine, memantine
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: November 16, 2011)	204
Original Enrollment ICMJE	Not Provided
Actual Study Completion Date	June 2005
Actual Primary Completion Date	June 2005 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	50 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	France
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00234637
Other Study ID Numbers ICMJE	CENA713BFR05
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Novartis
Study Sponsor ICMJE	Novartis
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Thierry Dantoine Centre Hospitalier Universitaire
PRS Account	Novartis
Verification Date	November 2011
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP