Study of Memantine in Assessment of Selected Measures of Volumetric Magnetic Resonance Imaging (MRI) and Cognition in Moderate AD (Alzheimer's Disease)
Status and phase
Completed
Phase 4
Conditions
Alzheimer's Disease
Treatments
Drug: memantine HCl
Details and patient eligibility
About
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.
Sex
All
Ages
50+ years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Non-Randomized
Interventional model
Single Group Assignment
Masking
None (Open label)
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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