Study of Memantine in Assessment of Selected Measures of Volumetric Magnetic Resonance Imaging (MRI) and Cognition in Moderate AD (Alzheimer's Disease)
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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: NCT00334906 |
Recruitment Status :
Completed
First Posted : June 8, 2006
Last Update Posted : January 7, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alzheimer's Disease | Drug: memantine HCl | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 75 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-Label Exploratory Study With Memantine: Assessment of Selected Measures of Volumetric MRI and Cognition in Patients With Moderate Dementia of the Alzheimer's Type |
Study Start Date : | July 2005 |
Actual Primary Completion Date : | November 2007 |

- Efficacy
- Total brain atrophy on MRI
- Other measures of brain atrophy on MRI, change from baseline in selected cognitive measures assessing multiple cognitive domains including memory, attention, motor-speed, auditory comprehension, and verbal fluency
- Safety

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Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Ambulatory male or female patients at least 50 years of age (females at least 2 years postmenopausal)
- A diagnosis of probable AD [according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Associations (NINCDS-ADRDA) criteria] of moderate severity [Mini-Mental State Examination score between 15 and 20, inclusive]
- On a stable dose of Food and Drug Administration (FDA)-approved acetylcholinesterase inhibitor
Exclusion Criteria:
- Current Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) Axis I disorder other than AD
- Previous imaging results not consistent with the diagnosis of AD
- Modified Hachinski Ischemia Score greater than 4
- Evidence of other neurologic disorders
- Inability to participate in MRI testing
- No clinically significant systemic disease
- A known or suspected history of alcohol or drug abuse in the past 10 years
- Taking excluded medication
- Previous treatment with commercial memantine

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): NCT00334906
United States, New Jersey | |
Forest Laboratories | |
Jersey City, New Jersey, United States, 07311 |
ClinicalTrials.gov Identifier: | NCT00334906 |
Other Study ID Numbers: |
MEM-MD-15 |
First Posted: | June 8, 2006 Key Record Dates |
Last Update Posted: | January 7, 2008 |
Last Verified: | January 2008 |
memantine Alzheimer's disease MRI moderate Alzheimer's disease |
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |
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 |