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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:
NCT01261741
First received: December 15, 2010
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Merz Pharmaceuticals GmbH:

Primary Outcome Measures:
  • "Patient Global Impression of Change" (PGI-C) at visit 4 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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:
  • Change from baseline to visit 3 and 5 of Patient Global Impression of Change (PGI-C) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to visit 4 in "Everyday Cognition 39" (ECog 39) total score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to visit 4 in "Hospital Anxiety and Depression Scale" (HADS) Score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to visit 3, 4, 5 of "Computer-based Neuropsychological Test Battery (C-NTB) by CogState Ltd. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 299
Study Start Date: November 2010
Study Completion Date: September 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01261741

Locations
Germany
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
Investigators
Study Director: Merz Medical Expert Merz Pharmaceuticals GmbH
  More Information

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

Responsible Party: Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier: NCT01261741     History of Changes
Other Study ID Numbers: MRZ 90001-2267 / 1, 2010-020737-50
Study First Received: December 15, 2010
Last Updated: November 26, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Memory Disorders
Cognition Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Memantine
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014