We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

Safety and Tolerability of Memantine in Moderate to Severe Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00857233
Recruitment Status : Terminated (Please see explanation in the Detailed Description field.)
First Posted : March 6, 2009
Results First Posted : August 29, 2012
Last Update Posted : August 29, 2012
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Memantine Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 297 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2004
Primary Completion Date : July 2010
Study Completion Date : October 2010

Arms and Interventions

Arm Intervention/treatment
Experimental: Memantine Drug: Memantine
20 mg oral tablets once daily
Other Name: Ebixa®

Outcome Measures

Primary Outcome Measures :
  1. Number of Patients With Adverse Events (AEs) [ Time Frame: Baseline to Week 24 ]
    Overview of AEs

  2. Percentage of Patients Who Withdrew Due to Intolerance to Treatment [ Time Frame: Baseline to Week 24 ]

Secondary Outcome Measures :
  1. Long-term Efficacy of Memantine on Behavioural Symptoms Using the Neuropsychiatric Inventory (NPI) - 12 Items Version Total Score. [ Time Frame: Baseline and Week 24 ]

    Change from Baseline in the NPI total score. Analysed by descriptive methods only.

    NPI is a validated scale that assesses behavioural disturbances in patients with dementia. The 12 item version consists of 10 behavioural and 2 neurovegetative areas. It provides both a total score as well as scores for a number of sub-scales. The frequency, severity and caregiver distress for each domain are measured. The NPI is based upon responses obtained from the caregiver. The total score is from 0 to 144. A higher score reflects more frequency and severity of the disturbances.

  2. Long-term Efficacy of Memantine on Cognition Using the Severe Impairment Battery (SIB) Total Score. [ Time Frame: Baseline and Week 24 ]

    Change from Baseline in the SIB total score. Analysed by descriptive methods only.

    SIB is a validated scale used to assess cognitive function in patients with moderate to severe dementia. Items are single words or one-step commands combined with gestures. Nine domains are assessed, and the total score is between 0 and 100. A lower total score reflects the loss of cognitive function.

  3. Long-term Efficacy of Memantine on Global Condition Using the Clinician's Interview-Based Impression of Change-Plus Version (CIBIC-plus). [ Time Frame: Week 24 ]

    CIBIC-plus. Improvement evaluated with reference to Baseline. Analysed by descriptive methods only.

    CIBIC-plus is a global rating that is derived through an independent, comprehensive interview with the patient and caregiver by a rater who is barred from knowledge of all other psychometric test scores conducted as part of this protocol as well as from reported safety data. The rating is made on a 7-point scale ranging from "1 = marked improvement" to "7 = marked worsening". A score of "4" indicates no change.

  4. 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 [ Time Frame: Baseline and Week 24 ]

    Change from Baseline on the ADCS-ADL 19-item version total score. Analysed by descriptive methods only.

    ADCS-ADL- 19 items version for moderate to severe AD will measure patient's functioning. This battery of ADL questions is used here to measure the functional capabilities of patients with dementia. The inventory is done by interviewing a person in close contact with the patient and covers the most usual and consistent performance of the patient over the preceding 4 weeks. Total score is from 0 to 54. The higher score, the lower impairment.

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00857233

  Show 33 Study Locations
Sponsors and Collaborators
H. Lundbeck A/S
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
More Information

Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT00857233     History of Changes
Other Study ID Numbers: 10252
First Posted: March 6, 2009    Key Record Dates
Results First Posted: August 29, 2012
Last Update Posted: August 29, 2012
Last Verified: July 2012

Keywords provided by H. Lundbeck A/S:
Alzheimer's Disease

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents