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OpenTrials
Completed

NCT Number: NCT01261741

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

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.

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Key information

Conditions

Memory Disorder Memory Disorders Memory, Concentration or Attention Problems Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Retention Disorder, Cognitive Signs and Symptoms Subjective Cognitive Impairment

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Universitätsklinikum der RWTH Aachen, Aachen, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Memantine

Drug

Each subject will receive memantine 10mg tablets once daily

Placebo

Drug

Each subject will receive matching placebo tablets once daily

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Merz Pharmaceuticals GmbH

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 16, 2010
Registry last updated
Nov 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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