Study of Memantine in Assessment of Selected Measures of Volumetric Magnetic Resonance Imaging (MRI) and Cognition in Moderate AD (Alzheimer's Disease)
This study has been completed.
Sponsor:
Forest Laboratories
Information provided by:
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00334906
First received: June 6, 2006
Last updated: January 3, 2008
Last verified: January 2008
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Purpose
The purpose of this study is to characterize the progression of disease using volumetric MRI techniques and cognitive outcome measures in patients with moderate dementia of the Alzheimer's type treated with open-label memantine.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease |
Drug: memantine HCl |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Forest Laboratories:
Primary Outcome Measures:
- Efficacy
- Total brain atrophy on MRI
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 75 |
| Study Start Date: | July 2005 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00334906 History of Changes |
| Other Study ID Numbers: | MEM-MD-15 |
| Study First Received: | June 6, 2006 |
| Last Updated: | January 3, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Forest Laboratories:
|
memantine Alzheimer's disease MRI moderate Alzheimer's disease |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Memantine Dopamine Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on October 16, 2012
