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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01261741
Recruitment Status : Completed
First Posted : December 16, 2010
Last Update Posted : November 27, 2013
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Memory Disorder Retention Disorder, Cognitive Subjective Cognitive Impairment Memory, Concentration or Attention Problems Drug: Memantine Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 299 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : November 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Experimental: Memantine Drug: Memantine
Each subject will receive memantine 10mg tablets once daily

Placebo Comparator: Placebo Drug: Placebo
Each subject will receive matching placebo tablets once daily

Primary Outcome Measures :
  1. "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 Outcome Measures :
  1. Change from baseline to visit 3 and 5 of Patient Global Impression of Change (PGI-C) [ Time Frame: 16 weeks ]
  2. Change from baseline to visit 4 in "Everyday Cognition 39" (ECog 39) total score [ Time Frame: 12 weeks ]
  3. Change from baseline to visit 4 in "Hospital Anxiety and Depression Scale" (HADS) Score [ Time Frame: 12 weeks ]
  4. Change from baseline to visit 3, 4, 5 of "Computer-based Neuropsychological Test Battery (C-NTB) by CogState Ltd. [ Time Frame: 16 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01261741

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

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Responsible Party: Merz Pharmaceuticals GmbH Identifier: NCT01261741    
Other Study ID Numbers: MRZ 90001-2267 / 1
2010-020737-50 ( EudraCT Number )
First Posted: December 16, 2010    Key Record Dates
Last Update Posted: November 27, 2013
Last Verified: November 2013
Additional relevant MeSH terms:
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Memory Disorders
Pathologic Processes
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents