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

Phase 2

Completed

• Conditions: Subjective Cognitive Impairment; Memory, Concentration or Attention Problems; Retention Disorder, Cognitive; Memory Disorder
• Interventions: Drug: Placebo; Drug: Memantine

• Registration Number: NCT01261741
• Lead Sponsor: Merz Pharmaceuticals GmbH

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-12-15
• Study First Submitted QC: 2010-12-15
• Study First Posted: 2010-12-16
• Primary Completion: 2011-08
• Study Completion: 2011-09
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-26
• Last Update Posted: 2013-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 299

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Memantine	Memantine	-

Primary Outcome Measures

Name	Time	Method
"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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (14)

Praxis Dr. Heidenreich; 🇩🇪 Böblingen, Germany

Praxis Dr. Krause; 🇩🇪 Wolfratshausen, Germany

Klinische Forschung Berlin-Mitte; 🇩🇪 Berlin-Mitte, Germany

Universitätsklinikum Carl Gustav Carus; 🇩🇪 Dresden, Germany

Praxis Dr. Albrecht; 🇩🇪 Ellwangen, Germany

Praxis Dr. Reifschneider; 🇩🇪 Erbach, Germany

Klinische Forschung Hannover-Mitte; 🇩🇪 Hannover, Germany

Universitätsklinikum der RWTH Aachen; 🇩🇪 Aachen, Germany

ZSL Zentrum für medizinische Studien in Leipzig; 🇩🇪 Leipzig, Germany

Praxis Dr. Pauls; 🇩🇪 München, Germany

Praxis Dr. Kühn; 🇩🇪 Oranienburg, Germany

Community Pharmacology Services (CPS); 🇬🇧 Glasgow, United Kingdom

Royal United Hospital; 🇬🇧 Bath, United Kingdom

Moorgreen Hospital; 🇬🇧 West End, Southampton, United Kingdom