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

NCT ID: NCT01261741

Last Updated: 2013-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

299 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Memory Disorder Retention Disorder, Cognitive Subjective Cognitive Impairment Memory, Concentration or Attention Problems

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Memantine

Group Type EXPERIMENTAL

Memantine

Intervention Type DRUG

Each subject will receive memantine 10mg tablets once daily

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Each subject will receive matching placebo tablets once daily

Interventions

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Memantine

Each subject will receive memantine 10mg tablets once daily

Intervention Type DRUG

Placebo

Each subject will receive matching placebo tablets once daily

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merz Pharmaceuticals GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Merz Medical Expert

Role: STUDY_DIRECTOR

Merz Pharmaceuticals GmbH

Locations

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Universitätsklinikum der RWTH Aachen

Aachen, , Germany

Site Status

Praxis Dr. Heidenreich

Böblingen, , Germany

Site Status

Universitätsklinikum Carl Gustav Carus

Dresden, , Germany

Site Status

Praxis Dr. Albrecht

Ellwangen, , Germany

Site Status

Praxis Dr. Reifschneider

Erbach im Odenwald, , Germany

Site Status

Klinische Forschung Hannover-Mitte

Hanover, , Germany

Site Status

ZSL Zentrum für medizinische Studien in Leipzig

Leipzig, , Germany

Site Status

Klinische Forschung Berlin-Mitte

Mitte, , Germany

Site Status

Praxis Dr. Pauls

München, , Germany

Site Status

Praxis Dr. Kühn

Oranienburg, , Germany

Site Status

Praxis Dr. Krause

Wolfratshausen, , Germany

Site Status

Royal United Hospital

Bath, , United Kingdom

Site Status

Community Pharmacology Services (CPS)

Glasgow, , United Kingdom

Site Status

Moorgreen Hospital

West End, Southampton, , United Kingdom

Site Status

Countries

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Germany United Kingdom

References

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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

Reference Type RESULT

Other Identifiers

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2010-020737-50

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MRZ 90001-2267 / 1

Identifier Type: -

Identifier Source: org_study_id