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

Alzheimer's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00234637
• Other study ID #: CENA713BFR05
• Status: Completed
• Phase: Phase 4
• First received: October 5, 2005
• Last updated: November 16, 2011
• Start date: November 2003
• Est. completion date: June 2005

Study information

• Verified date: November 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: June 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Rivastigmine, memantine

Locations

Country	Name	City	State
France	Département de Gérontologie Clinique	Limoges	Cedex

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of responders (cognitive function stable or improved) at the end of phase 2 (vs. end of phase 1).
Secondary	Change in cognition at weeks 16 and 28 (end of period 1) compared to baseline
Secondary	Change in caregiver burden at weeks 16 and 28 (end of period 1) compared to baseline
Secondary	Change in behavior at weeks 16 and 28 (end of period 1) compared to baseline
Secondary	Change in executive function at weeks 16 and 28 (end of period 1) compared to baseline