Status:
COMPLETED
The Effect of Memantine on Brain Structure and Chemistry in Alzheimer's Disease Patients
Lead Sponsor:
Stanford University
Collaborating Sponsors:
Palo Alto Veterans Institute for Research
Forest Laboratories
Conditions:
Alzheimer Disease
Eligibility:
All Genders
50-95 years
Phase:
PHASE3
Brief Summary
The aim of the proposed study is to determine if the NMDA receptor antagonist memantine has a neuroprotective effect on magnetic resonance spectroscopic imaging (MRS) measures of brain NAA and magneti...
Detailed Description
Alzheimer's disease (AD) is the most common form of dementia. Currently, there are more than 4 million individuals with dementia in the United States with at least 400,000 deaths annually. AD is a pro...
Eligibility Criteria
Inclusion
- Dementia criteria by DSM-IV.
- 2\. 50-95 years of age inclusive.
- 3\. MMSE at screen and baseline 7-28 inclusive.
- 4\. Conversant in English.
- 5\. Caregiver/study partner willing to participate, supervise the patient and be available for administration of study medication.
- 6\. Able to ingest oral medication.
Exclusion
- History of clinically significant stroke without substantial recovery.
- 2\. Neurological or medical conditions causing significant disability independent of dementia.
- 3\. Parkinson's disease.
- 4\. History in past two years of focal brain lesion, head injury with loss of consciousness or DSM-IV criteria for any major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse.
- 5\. Dementia due to Korsakoff's syndrome or infectious diseases such as Creutzfeldt-Jakob disease, herpes, encephalitis, or human immunodeficiency virus.
- 6\. Sensory impairment that would prevent subject from participating in or cooperating with the protocol.
- 7\. Significant clinical disorder or laboratory finding that renders the subject unsuitable for receiving an investigational drug including: clinically significant or unstable hematologic, hepatic, cardiovascular, pulmonary, gastrointestinal, endocrine, metabolic, renal, or other systemic disease or laboratory abnormality.
- 8\. Clinical contraindication to the use of memantine (e.g., hypersensitivity).
- 9\. History of seizure within past 5 years prior to screening.
- 10\. Platelet count \< 100,000/mm3.
- 11\. History of claustrophobia
- 12\. Presence of metallic implants such as pacemakers, surgical aneurysm clips, or known metal fragments embedded in the body
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00255086
Start Date
May 1 2005
End Date
February 1 2010
Last Update
April 7 2017
Active Locations (1)
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1
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304