Overview

The Effect of Memantine on Brain Structure and Chemistry in Alzheimer's Disease Patients

Status:
Completed
Trial end date:
2010-02-01
Target enrollment:
0
Participant gender:
All
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 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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Stanford University
Collaborators:
Forest Laboratories
Palo Alto Veterans Institute for Research
Treatments:
Memantine
Criteria
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. 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