CompletedPhase 2

Investigation of Memantine in the Treatment of Memory, Concentration or Attention Problems

Prospective, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Investigate the Efficacy and Safety of 10mg Memantine in the Treatment of Memory, Concentration or Attention Problems in the Absence of Dementia

Lead sponsor

Merz Pharmaceuticals GmbH

Asset

Memantine

Listed sites

Recruiting sites

Enrollment

299

actual

Study population

Mixed / unspecified dementia

Key I/E criterion

•Age 50-80

Primary endpoint

•"Patient Global Impression of Change" (PGI-C)

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

Eudract number2010-020737-50

Org study IDMRZ 90001-2267 / 1

NCT IDNCT01261741

Timeline

Milestones

Study start2010-11 (month precision)

Study first posted2010-12-16estimated

Primary completion2011-08actual (month precision)

Study completion2011-09actual (month precision)

Last update posted2013-11-27estimated

Assets

Drug assets

Memantine

Study populations

Who this study enrolls

Mixed / unspecified dementia

Eligibility

Who can enroll

Minimum age50 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Subjective worsening of memory, concentration or attention problems for longer than 6 months

•Subject can confirm that a relative or friend has noticed the memory, concentration or attention problems of the subject

•Experience of the memory, concentration or attention problems at least four times per week

Exclusion criteria

•Significant neurological disease or major psychiatric disorder (e.g. diagnosis of psychosis or dementia)

•Significant systemic illness, such as cancer, heart or kidney failure, uncontrolled diabetes

•History of stroke or seizure, or myocardial infarction within the last year (e.g. by inclusion questionnaire, physician interview)

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

Other (unclassified)

Global cognition

Behavior / neuropsychiatric

Global cognition

1 endpoint

Secondary/protocol endpoint

Change from baseline to visit 3, 4, 5 of "Computer-based Neuropsychological Test Battery (C-NTB) by CogState Ltd.

Time frame:16 weeks

change from baseline, improvement

Behavior / neuropsychiatric

1 endpoint

Secondary/protocol endpoint

Change from baseline to visit 4 in "Hospital Anxiety and Depression Scale" (HADS) Score

Time frame:12 weeks

change from baseline, improvement

Other (unclassified)

3 endpoints

Primary/protocol endpoint/low confidence

"Patient Global Impression of Change" (PGI-C) at visit 4

Time frame:12 weeks

descriptive

Secondary/protocol endpoint/low confidence

Change from baseline to visit 3 and 5 of Patient Global Impression of Change (PGI-C)

Time frame:16 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from baseline to visit 4 in "Everyday Cognition 39" (ECog 39) total score

Time frame:12 weeks

change from baseline, improvement

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.