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CompletedPhase 4

Memantine and Changes of Biological Markers and Brain PET Imaging in Alzheimer's Disease

Changes of Biological Markers and Brain PET Imaging and Clinical Effects of Memantine for Patients With Moderate to Severe Alzheimer's Disease: a 24 Week Double-blind, Randomized, Placebo-Controlled Study

Asset

Memantine

Listed sites

1

Recruiting sites

-

Enrollment

26

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 4-20

Primary endpoints

•Biological markers of CSF•18[F]-FDG-PET of brain•Cognitive function

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 IDIIT_12484A
NCT IDNCT00800709

Timeline

Milestones

Study start2008-07 (month precision)
Study first posted2008-12-02estimated
Primary completion2010-10actual (month precision)
Study completion2010-10actual (month precision)
Last update posted2010-12-03estimated

Assets

Drug assets

Memantine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
Maximum age90 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Written informed consent

2. Clinical diagnosis of Alzheimer's disease which meet the DSM-IV criteria.

3. Subject has moderate to severe Alzheimer's disease as defined by a MMSE score 4 to 20 inclusive at screening.

4. Hachinski Ischemia Score < 4 at screening.

5. Age ≥50 and ≤90 years.

6. Availability of a responsible and steady caregiver to ensure treatment compliance and provide information for assessments

Exclusion criteria

1. Severe renal impairment.

2. History of seizures

3. Systolic blood pressure >160 or < 90 mmHg or diastolic blood pressure > 95 or < 60 mmHg at the time of screening.

4. Diagnosis of any concomitant life threatening illness.

Endpoints (5)

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
1
Memory
1
Function / daily living
1
Neuroimaging
1
Fluid / digital biomarkers
1

Global cognition

1 endpoint
Primary/protocol endpoint

cognitive function

Time frame:24 weeks

descriptive

Memory

1 endpoint
Secondary/protocol endpoint

short term memory

Time frame:24 weeks

descriptive

Function / daily living

1 endpoint
Secondary/protocol endpoint

behavior and activities of daily living

Time frame:24 weeks

descriptive

Neuroimaging

1 endpoint
Primary/protocol endpoint

18[F]-FDG-PET of brain

Time frame:24 weeks

descriptive

Fluid / digital biomarkers

1 endpoint
Primary/protocol endpoint

biological markers of CSF

Time frame:24 weeks

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

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.