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The Effect of Memantine on Brain Structure and Chemistry in Alzheimer's Disease Patients
The Effect of Memantine on Brain Structure and Chemistry in Alzheimer's Disease Patients: A Randomized, Placebo-Controlled, 52-Week Clinical Trial
Lead sponsor
Asset
Memantine
Listed sites
1
Recruiting sites
-
Enrollment
17
actual
Study population
Alzheimer’s disease
Key I/E criterion
•MMSE 7-28
Primary endpoint
•NAA/Cr Ratio
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
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
Endpoints (4)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Global cognition
2 endpointsMean Change on the ADAS-Cog Score After 1 Year
Time frame:Baseline; Year 1
ADAS-Cog
descriptive
Mean Change on the ADAS-Cog Score After 1 Year
Time frame:Baseline; Year 1
ADAS-Cog
descriptive
Posted result
| Group | Value (mean), units on a scale | Standard deviation |
|---|---|---|
| MemantineBaselinen=4 Participants | 44.67 | 10.30 |
| 1 Yearn=4 Participants | 45.75 | 7.99 |
| ControlBaselinen=6 Participants | 49.17 | 8.37 |
| 1 Yearn=6 Participants | 50.39 | 8.88 |
Neuroimaging
2 endpointsNAA/Cr Ratio
Time frame:Baseline; Year 1
ratio, descriptive
NAA/Cr Ratio
Time frame:Baseline; Year 1
ratio, descriptive
Posted result
| Group | Value (mean), Ratio | Standard deviation |
|---|---|---|
| MemantineBaselinen=4 Participants | 1.47 | 0.11 |
| Year 1n=4 Participants | 1.62 | 0.14 |
| ControlBaselinen=6 Participants | 1.38 | 0.10 |
| Year 1n=6 Participants | 1.41 | 0.10 |
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.