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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01261741

Enrollment

299

Registered

2010-12-16

Start date

2010-11-30

Completion date

2011-09-30

Last updated

2013-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Memory, Concentration or Attention Problems, Memory Disorder, Retention Disorder, Cognitive, Subjective Cognitive Impairment

Brief summary

In this study, memantine will be tested in a new indication: in the treatment of subjective memory, concentration, or attention problems (subjective cognitive impairment) in the absence of dementia.

Interventions

DRUGMemantine

Each subject will receive memantine 10mg tablets once daily

DRUGPlacebo

Each subject will receive matching placebo tablets once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

50 Years to 80 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Patient Global Impression of Change (PGI-C) at visit 4	12 weeks	It is the statistical comparison between the placebo group and the memantine group.The group comparison will be performed by the use of an analysis of covariance (ANCOVA) model.

Secondary

Measure	Time frame
Change from baseline to visit 3 and 5 of Patient Global Impression of Change (PGI-C)	16 weeks
Change from baseline to visit 4 in Everyday Cognition 39 (ECog 39) total score	12 weeks
Change from baseline to visit 4 in Hospital Anxiety and Depression Scale (HADS) Score	12 weeks
Change from baseline to visit 3, 4, 5 of Computer-based Neuropsychological Test Battery (C-NTB) by CogState Ltd.	16 weeks

Countries

Germany, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026