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

Subjective Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01261741
• Other study ID #: MRZ 90001-2267 / 1
• Secondary ID: 2010-020737-50
• Status: Completed
• Phase: Phase 2
• First received: December 15, 2010
• Last updated: November 26, 2013
• Start date: November 2010
• Est. completion date: September 2011

Study information

• Verified date: November 2013
• Source: Merz Pharmaceuticals GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 299
• Est. completion date: September 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Disease
• Memory Disorder
• Memory Disorders
• Memory, Concentration or Attention Problems
• Retention Disorder, Cognitive
• Subjective Cognitive Impairment

Intervention

Drug:
• Memantine
Each subject will receive memantine 10mg tablets once daily
• Placebo
Each subject will receive matching placebo tablets once daily

Locations

Country	Name	City	State
Germany	Universitätsklinikum der RWTH Aachen	Aachen
Germany	Klinische Forschung Berlin-Mitte	Berlin-Mitte
Germany	Praxis Dr. Heidenreich	Böblingen
Germany	Universitätsklinikum Carl Gustav Carus	Dresden
Germany	Praxis Dr. Albrecht	Ellwangen
Germany	Praxis Dr. Reifschneider	Erbach
Germany	Klinische Forschung Hannover-Mitte	Hannover
Germany	ZSL Zentrum für medizinische Studien in Leipzig	Leipzig
Germany	Praxis Dr. Pauls	München
Germany	Praxis Dr. Kühn	Oranienburg
Germany	Praxis Dr. Krause	Wolfratshausen
United Kingdom	Royal United Hospital	Bath
United Kingdom	Community Pharmacology Services (CPS)	Glasgow
United Kingdom	Moorgreen Hospital	West End, Southampton

Sponsors (1)

Lead Sponsor	Collaborator
Merz Pharmaceuticals GmbH

Countries where clinical trial is conducted

Germany,  United Kingdom, 

References & Publications (1)

Schulz JB, Acker C, Seitzinger A, Pulte I. Randomized, double-blind, placebo-controlled, multicentre study to investigate memantine in the treatment of memory, concentration, and attention problems (subjective cognitive impairment). Journal of the Neurolo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	"Patient Global Impression of Change" (PGI-C) at visit 4	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.	12 weeks	No
Secondary	Change from baseline to visit 3 and 5 of Patient Global Impression of Change (PGI-C)		16 weeks	No
Secondary	Change from baseline to visit 4 in "Everyday Cognition 39" (ECog 39) total score		12 weeks	No
Secondary	Change from baseline to visit 4 in "Hospital Anxiety and Depression Scale" (HADS) Score		12 weeks	No
Secondary	Change from baseline to visit 3, 4, 5 of "Computer-based Neuropsychological Test Battery (C-NTB) by CogState Ltd.		16 weeks	No