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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00234637
• Date of registration: 05/10/2005
• Prospective Registration: No
• Primary sponsor: Novartis
• Public 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
• Scientific 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
• Date of first enrolment: November 2003
• Target sample size: 204
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00234637
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

France

Contacts

• Name: Thierry Dantoine
• Affiliation: Centre Hospitalier Universitaire

Key inclusion & exclusion 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



Age minimum: 50 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Alzheimer's Disease

Intervention(s)

Drug: Rivastigmine, memantine

Primary Outcome(s)

The proportion of responders (cognitive function stable or improved) at the end of phase 2 (vs. end of phase 1).

Secondary Outcome(s)

Change in caregiver burden at weeks 16 and 28 (end of period 1) compared to baseline

Change in cognition 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

Secondary ID(s)

CENA713BFR05

Source(s) of Monetary Support

Please refer to primary and secondary sponsors