Jerome Yesavage
The Effect of Memantine on Brain Structure and Chemistry in Alzheimer's Disease Patients
Contact Information
VA Palo Alto Health Care System 3801 Miranda Avenue Palo Alto, CA 94304Brief
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 magnetic resonance imaging (MRI) volumetric measures of hippocampal volume. In secondary analyses, we will determine if measures of clinical stabilization produced by memantine in the treatment of Alzheimer's disease (AD) parallels stabilization of MRS measures of brain NAA and MRI volumetric measures of hippocampal volume.
Recruiting Status:
CompletedStanford Recruiting Status:
Condition(s):
Intervention(s):
- Drug: Memantine
Phase:
Phase 3Eligibility
Ages Eligible for Study:
50 years to 95 yearsGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
1. 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.
Key Exclusion Criteria:
1. 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
Additional Study Details
Official Title:
The Effect of Memantine on Brain Structure and Chemistry in Alzheimer's Disease Patients: A Randomized, Placebo-Controlled, 52-Week Clinical TrialAnticipated start date:
5/1/2005Lead Sponsor:
Stanford UniversityCollaborator(s):
- Palo Alto Institute for Research and Education, Inc. (PAIRE)
- Forest Laboratories
Investigator(s):
- J. Wesson Ashford Jr., MD, PhD
- Jerome A Yesavage
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
ParallelEndpoints:
Pharmacokinetics/dynamicsPrimary Outcomes:
- MRS measures of brain NAA and MRI measures of hippocampal volume will serve as the primary outcome measures
Secondary Outcomes:
- Progression as measured by performance on the ADAS-Cog and caregiver and clinician ratings.
Total Number to be Enrolled:
15Total Number to be Enrolled at Stanford:
0More Information
Locations & Contacts
Stanford Locations & Contacts:
VA Palo Alto Health Care System 3801 Miranda Avenue Palo Alto, CA 94304Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
1/14/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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