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

Merz Pharmaceuticals GmbH14 sites in 2 countries299 target enrollmentNovember 2010

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

InterventionsMemantine Placebo

DrugsMemantine Placebo

Overview

Phase: Phase 2
Intervention: Memantine
Conditions: Memory Disorder
Sponsor: Merz Pharmaceuticals GmbH
Enrollment: 299
Locations: 14
Primary Endpoint: "Patient Global Impression of Change" (PGI-C) at visit 4
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2010

End Date

September 2011

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Merz Pharmaceuticals GmbH

Responsible Party

Sponsor

Eligibility Criteria

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)

Arms & Interventions

Memantine

Intervention: Memantine

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

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

Time Frame: 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 Outcomes

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)