An Open-label Extension Study Examining the Safety and Tolerability of Memantine in Patients With Moderate to Severe Dementia of the Alzheimer's Type Having Completed Study 10158
Overview
- Phase
- Phase 3
- Intervention
- Memantine
- Conditions
- Alzheimer's Disease
- Sponsor
- H. Lundbeck A/S
- Enrollment
- 297
- Locations
- 33
- Primary Endpoint
- Number of Patients With Adverse Events (AEs)
- Status
- Terminated
- Last Updated
- 13 years ago
Overview
Brief Summary
The primary objective of the study was to examine the safety and tolerability of memantine in outpatients with moderate to severe Alzheimer's Disease.
Detailed Description
Memantine is a moderate affinity, uncompetitive N-methyl-D-aspartate (NMDA) receptor antagonist. Pre-clinical studies have demonstrated that memantine can decrease the neuronal toxicity associated with excessive glutamate release and calcium overload in neurons. Results from clinical trials in patients with moderate to severe Alzheimer's Disease (AD) have demonstrated memantine's efficacy and safety by showing positive treatment effects on cognitive, global and functional decline. The purpose of this 24-week open-label extension study was to collect additional long-term safety and tolerability data on memantine in patients who completed the lead-in double-blind placebo-controlled Study 10158. In agreement with Health Canada the study was prematurely terminated due to recruitment difficulties in the lead-in Study 10158. Patients ongoing in the study when the decision to terminate was taken were allowed to complete it.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Ambulatory outpatients with moderate to severe dementia of the Alzheimer's type who have completed the 24-week Study 10158 and who have a knowledgeable and reliable caregiver who will accompany the patient to all clinic visits during the course of the study.
Exclusion Criteria
- •Diseases/medication which judged by the investigator could interfere with the assessments of safety, tolerability or efficacy.
Arms & Interventions
Memantine
Intervention: Memantine
Outcomes
Primary Outcomes
Number of Patients With Adverse Events (AEs)
Time Frame: Baseline to Week 24
Overview of AEs
Percentage of Patients Who Withdrew Due to Intolerance to Treatment
Time Frame: Baseline to Week 24
Secondary Outcomes
- Long-term Efficacy of Memantine on Behavioural Symptoms Using the Neuropsychiatric Inventory (NPI) - 12 Items Version Total Score.(Baseline and Week 24)
- Long-term Efficacy of Memantine on Cognition Using the Severe Impairment Battery (SIB) Total Score.(Baseline and Week 24)
- Long-term Efficacy of Memantine on Global Condition Using the Clinician's Interview-Based Impression of Change-Plus Version (CIBIC-plus).(Week 24)
- Long-term Efficacy of Memantine on Functioning Using the Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) 19-item Version Total Score(Baseline and Week 24)