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

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.

Study Overview

• Status: Completed
• Conditions: Memory Disorder; Subjective Cognitive Impairment; Retention Disorder, Cognitive; Memory, Concentration or Attention Problems
• Intervention / Treatment: Drug: Memantine; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 299
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Aachen, Germany, 52074
    • Universitatsklinikum der RWTH Aachen
  • Berlin-Mitte, Germany, 10117
    • Klinische Forschung Berlin-Mitte
  • Böblingen, Germany, 71032
    • Praxis Dr. Heidenreich
  • Dresden, Germany, 01307
    • Universitätsklinikum Carl Gustav Carus
  • Ellwangen, Germany, 73479
    • Praxis Dr. Albrecht
  • Erbach, Germany, 64711
    • Praxis Dr. Reifschneider
  • Hannover, Germany, 30159
    • Klinische Forschung Hannover-Mitte
  • Leipzig, Germany, 04157
    • ZSL Zentrum für medizinische Studien in Leipzig
  • München, Germany, 80331
    • Praxis Dr. Pauls
  • Oranienburg, Germany, 16515
    • Praxis Dr. Kühn
  • Wolfratshausen, Germany, 82515
    • Praxis Dr. Krause
• United Kingdom
  • Bath, United Kingdom, BA1 3NG
    • Royal United Hospital
  • Glasgow, United Kingdom, G20 0XA
    • Community Pharmacology Services (CPS)
  • West End, Southampton, United Kingdom, SO30 3JB
    • Moorgreen Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Each subject will receive matching placebo tablets once daily
Experimental: Memantine	Drug: Memantine; Each subject will receive memantine 10mg tablets once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
"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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Merz Pharmaceuticals GmbH

Publications and helpful links

General Publications

• 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 Neurological Sciences 333 Suppl.1: e332, 2013. doi:10.1016/j.jns.2013.07.1232

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: December 15, 2010
• First Submitted That Met QC Criteria: December 15, 2010
• First Posted (Estimate): December 16, 2010

Study Record Updates

• Last Update Posted (Estimate): November 27, 2013
• Last Update Submitted That Met QC Criteria: November 26, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Memory Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Dopamine Agents; Antiparkinson Agents; Anti-Dyskinesia Agents; Memantine
• Other Study ID Numbers: MRZ 90001-2267 / 1; 2010-020737-50 (EudraCT Number)