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CompletedPhase 3

Memantine and Validation of a New Alzheimer's Disease Scale

Open Label, Single-Arm, Multi-Centre, Study to Validate a New Alzheimer's Disease Scale in Patients With DAT, Treated With Memantine

Asset

Memantine

Listed sites

1

Recruiting sites

-

Enrollment

487

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoint

•Validation of new scale regarding content, reliability

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

SecondaryEudraCT No. 2008-005144-16
Org study IDMRZ 90001/AD/3001
NCT IDNCT00804271

Timeline

Milestones

Study start2008-12 (month precision)
Study first posted2008-12-08estimated
Primary completion2009-11actual (month precision)
Study completion2009-11actual (month precision)
Last update posted2013-02-22estimated

Assets

Drug assets

Memantine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Diagnosis of probable Alzheimer's disease consistent with NINCDS-ADRDA criteria or with DSM IV TR criteria for Dementia of Alzheimer's type.
•Signed informed consent prior to the initiation of any study specific procedures.
•Sight and hearing (a hearing aid is permitted) are sufficiently good to allow the undertaking of study-related procedures and psychometric tests

Exclusion criteria

•Evidence of clinically significant and active pulmonary, gastrointestinal, renal, hepatic, endocrine or cardiovascular system disease.
•Intake of any medication that is contra-indicated in combination with memantine.
•History of severe drug allergy, or hypersensitivity, or patients with known hypersensitivity to ingredients of memantine or lactose.
•Known or suspected history of alcoholism or drug abuse within the past 2 years.
•Current or previous treatment with memantine or participation in an investigational study with memantine.

Endpoints (2)

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
Other (unclassified)
1

Global cognition

1 endpoint
Secondary/protocol endpoint

Assessment of treatment response and correlation of new scale against ADAScog, SIB, NPI, DAD.

Time frame:at a post baseline visit

ADAS-Cog

descriptive

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

Validation of new scale regarding content, reliability and responsiveness for DAT symptoms

Time frame:at post baseline visit

descriptive

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.