Skip to main content
Delfa

← Trials/Trial dossier/NCT00624026

CompletedPhase 3

Memantine - Communication Study

Prospective, Single-arm, Multicenter, Open-label Study to Investigate the Efficacy and Tolerability of the Once Daily (OD) Memantine Treatment

Asset

Memantine

Listed sites

1

Recruiting sites

-

Enrollment

107

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoint

•Efficacy of the memantine OD IR treatment

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 IDMRZ 90001-0608/1
NCT IDNCT00624026

Timeline

Milestones

Study start2007-11 (month precision)
Study first posted2008-02-26estimated
Primary completion2008-12actual (month precision)
Study completion2008-12actual (month precision)
Last update posted2011-11-01estimated

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

•Male or female outpatient at least 50 years of age and at least 8 years of education.
•The patient should have German as a mother-tongue or at least speak the language fluently in order to achieve similar scores in verbal tasks.
•Current diagnosis of probable Alzheimer's disease consistent with NINCDS- ADRDA criteria or with DSM IV TR criteria for Dementia of the Alzheimer's type.
•Mini Mental State Examination (MMSE) total score is less than 20
•Patients treated with any acetylcholinesterase inhibitor (AChEI) may be included, when treatment has started at least 6 months prior screening and was stable during the last 3 months

Exclusion criteria

•Any type of evident aphasia, which may interfere with patient's communication difficulties caused by Alzheimer's disease
•History of severe drug allergy, or hypersensitivity, or patients with known hypersensitivity to amantadine, lactose.
•Evidence (including CT/MRI results) of any clinically significant central nervous system disease other than Alzheimer's disease.
•Modified Hachinski Ischemia score greater than 4 at screening.
•Current evidence of clinically significant systemic disease
•Known or suspected history of alcoholism or drug abuse within the past 10 years.
•Previous treatment with memantine or participation in an investigational study with memantine.

Endpoints (1)

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.

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

To assess the efficacy of the memantine OD IR treatment using the Consortium to establish a registry for Alzheimer's Disease (CERAD-NP) total score

Time frame:4 months

descriptive

Publications (1)

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.