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A Clinical Study Evaluating the Effects of Memantine on Brain Atrophy in Patients With Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT00862940
Recruitment Status : Completed
First Posted : March 17, 2009
Results First Posted : June 3, 2011
Last Update Posted : September 3, 2012
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

Study Description
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Brief Summary:
Pre-clinical studies have demonstrated that memantine can decrease the neuronal toxicity associated with excessive glutamate release and calcium overload in neurons. Previous studies have shown that memantine helps to treat the symptoms of Alzheimer's Disease (AD). In AD, the rate of brain tissue loss, or atrophy, is faster than in normal aging and this seems to go hand in hand with some of the symptoms of the disease. This suggests that memantine treatment in AD could provide both symptomatic improvement and neuro-protective effects. The purpose of this study was to show whether memantine, in addition to providing symptomatic benefits, can slow the rate of brain atrophy as assessed using magnetic resonance imaging (MRI) technology.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Memantine Drug: Placebo Phase 4

Detailed Description:
The primary objective of this study was to evaluate the effects of memantine on the rate of brain atrophy compared to placebo in patients with AD (moderate severity) over a 1-year period. This was a multinational, randomised, double-blind, parallel-group, placebo-controlled, fixed-dose study (20 mg memantine). The study also included secondary imaging, cognitive and behavioural measures.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 277 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A 1-year Randomised, Double-blind Placebo-controlled Study to Evaluate the Effects of Memantine on Rate of Brain Atrophy in Patients With Alzheimer's Disease
Study Start Date : September 2005
Actual Primary Completion Date : February 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Memantine Drug: Memantine
10 mg tablets twice daily
Other Name: Ebixa®
Placebo Comparator: Placebo Drug: Placebo
Tablets twice daily


Outcome Measures
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Primary Outcome Measures :
  1. Total Brain Atrophy Rate Estimated Using Brain Boundary Shift Integral (BBSI) [ Time Frame: Baseline to 1 year ]
    Measures direct changes in total brain volume per visit interval (screening to Week 4, 42, or 52 or from Week 4 to Week 42 or 52)


Secondary Outcome Measures :
  1. Changes in Total Hippocampal Volume (HCV) [ Time Frame: Baseline to 1 year ]
    Estimated mean changes in total HCV

  2. Cognitive and Behavioural Outcomes: Controlled Oral Word Association Test (COWAT) Total Score [ Time Frame: Baseline to 1 year ]
    Adjusted mean change from baseline on cognitive and behavioural scores. COWAT: Verbal fluency test. The patient was asked to, during 1 minute, generate as many words as possible beginning with three pre-specified letters. The total score was calculated as the sum of acceptable words generated, with higher scores indicating lower cognitive impairment

  3. Cognitive and Behavioural Outcomes: Mini Mental State Examination (MMSE) Total Score [ Time Frame: Baseline to 1 year ]
    Adjusted mean change from baseline on cognitive and behavioural scores. MMSE: Brief, structured examination of mental status that assesses orientation, memory, attention, naming, comprehension, and praxis. The range is 0 to 30, with a lower score indicating a worse mental state


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

Inclusion Criteria:

  • Outpatients at least 50 years of age with a current diagnosis of probable AD of moderate severity (MMSE score between 12 and 20, inclusive) consistent with NINCDS-ADRDA criteria and MRI scans
  • Patients must have had a knowledgeable and reliable caregiver to accompany them to all clinic visits during the study
  • Patients were either on or off existing acetylcholinesterase inhibitor (AChEI) treatment provided that the treatment had been initiated >6 months prior to screening, had stabilised with respect to dose for >3 months, and remained fixed during the entire study. AChEI treatment could not be initiated or modified during the study

Exclusion Criteria:

  • The patient had evidence of clinically significant active disease (including recent myocardial infarction and uncompensated congestive heart failure [NYHA II-IV])
  • The patient had evidence of any clinically significant neurodegenerative disease or neurological disorder other than AD
  • The patient was contraindicated for MRI

Other protocol-defined inclusion and exclusion criteria applied.

Contacts and Locations
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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): NCT00862940


Sponsors and Collaborators
H. Lundbeck A/S
Investigators
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Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
More Information
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Publications of Results:

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Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT00862940    
Other Study ID Numbers: 10112
2004-002614-10 ( EudraCT Number )
First Posted: March 17, 2009    Key Record Dates
Results First Posted: June 3, 2011
Last Update Posted: September 3, 2012
Last Verified: August 2012
Keywords provided by H. Lundbeck A/S:
Memantine
Neuroimaging
MRI
Brain atrophy
Additional relevant MeSH terms:
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Alzheimer Disease
Atrophy
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
 Pathological Conditions, Anatomical
Memantine
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