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CompletedPhase 3Results posted

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

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

Org study ID95722
NCT IDNCT00255086

Timeline

Milestones

Study start2005-05 (month precision)
Study first posted2005-11-17estimated
Primary completion2009-06actual (month precision)
Study completion2010-02actual (month precision)
Last update posted2017-04-07actual
Results first posted2017-04-07actual

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
Maximum age95 Years
SexAll
Healthy volunteersNot accepted

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
Neuroimaging
2

Global cognition

2 endpoints
Secondary/protocol endpoint

Mean Change on the ADAS-Cog Score After 1 Year

Time frame:Baseline; Year 1

ADAS-Cog

descriptive

Secondary/registry result

Mean Change on the ADAS-Cog Score After 1 Year

Time frame:Baseline; Year 1

ADAS-Cog

descriptive

Posted result

GroupValue (mean), units on a scaleStandard deviation
MemantineBaselinen=4 Participants44.6710.30
1 Yearn=4 Participants45.757.99
ControlBaselinen=6 Participants49.178.37
1 Yearn=6 Participants50.398.88

Neuroimaging

2 endpoints
Primary/protocol endpoint

NAA/Cr Ratio

Time frame:Baseline; Year 1

ratio, descriptive

Primary/registry result

NAA/Cr Ratio

Time frame:Baseline; Year 1

ratio, descriptive

Posted result

GroupValue (mean), RatioStandard deviation
MemantineBaselinen=4 Participants1.470.11
Year 1n=4 Participants1.620.14
ControlBaselinen=6 Participants1.380.10
Year 1n=6 Participants1.410.10

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableClinicalTrials.gov results section

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.