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

NCT00234637 | Completed Phase 4

• 1 other identifier: CENA713BFR05
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's disease,; switch,; rivastigmine,; memantine

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

• 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

Interventions

Rivastigmine, memantine DRUG

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Département de Gérontologie Clinique

Limoges, Cedex, 87042, France

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Rivastigmine; Memantine

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylcarbamates; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Thierry Dantoine

  Centre Hospitalier Universitaire

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2005
• First Posted: October 7, 2005
• Study Start: November 1, 2003
• Primary Completion: June 1, 2005
• Study Completion: June 1, 2005
• Last Updated: November 17, 2011

Record last verified: 2011-11

Locations

FR (1)