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

Primary Purpose

Memory Disorder, Retention Disorder, Cognitive, Subjective Cognitive Impairment

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Memantine
Placebo
Sponsored by
Merz Pharmaceuticals GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Memory Disorder

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Universitätsklinikum der RWTH Aachen
  • Klinische Forschung Berlin-Mitte
  • Praxis Dr. Heidenreich
  • Universitätsklinikum Carl Gustav Carus
  • Praxis Dr. Albrecht
  • Praxis Dr. Reifschneider
  • Klinische Forschung Hannover-Mitte
  • ZSL Zentrum für medizinische Studien in Leipzig
  • Praxis Dr. Pauls
  • Praxis Dr. Kühn
  • Praxis Dr. Krause
  • Royal United Hospital
  • Community Pharmacology Services (CPS)
  • Moorgreen Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Memantine

Placebo

Arm Description

Outcomes

Primary Outcome Measures

"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.

Secondary Outcome Measures

Change from baseline to visit 3 and 5 of Patient Global Impression of Change (PGI-C)
Change from baseline to visit 4 in "Everyday Cognition 39" (ECog 39) total score
Change from baseline to visit 4 in "Hospital Anxiety and Depression Scale" (HADS) Score
Change from baseline to visit 3, 4, 5 of "Computer-based Neuropsychological Test Battery (C-NTB) by CogState Ltd.

Full Information

First Posted
December 15, 2010
Last Updated
November 26, 2013
Sponsor
Merz Pharmaceuticals GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01261741
Brief Title
Investigation of Memantine in the Treatment of Memory, Concentration or Attention Problems
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 Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merz Pharmaceuticals GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Memory Disorder, Retention Disorder, Cognitive, Subjective Cognitive Impairment, Memory, Concentration or Attention Problems

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
299 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Memantine
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Memantine
Intervention Description
Each subject will receive memantine 10mg tablets once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Each subject will receive matching placebo tablets once daily
Primary Outcome Measure Information:
Title
"Patient Global Impression of Change" (PGI-C) at visit 4
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline to visit 3 and 5 of Patient Global Impression of Change (PGI-C)
Time Frame
16 weeks
Title
Change from baseline to visit 4 in "Everyday Cognition 39" (ECog 39) total score
Time Frame
12 weeks
Title
Change from baseline to visit 4 in "Hospital Anxiety and Depression Scale" (HADS) Score
Time Frame
12 weeks
Title
Change from baseline to visit 3, 4, 5 of "Computer-based Neuropsychological Test Battery (C-NTB) by CogState Ltd.
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merz Medical Expert
Organizational Affiliation
Merz Pharmaceuticals GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Universitätsklinikum der RWTH Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Klinische Forschung Berlin-Mitte
City
Berlin-Mitte
ZIP/Postal Code
10117
Country
Germany
Facility Name
Praxis Dr. Heidenreich
City
Böblingen
ZIP/Postal Code
71032
Country
Germany
Facility Name
Universitätsklinikum Carl Gustav Carus
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Praxis Dr. Albrecht
City
Ellwangen
ZIP/Postal Code
73479
Country
Germany
Facility Name
Praxis Dr. Reifschneider
City
Erbach
ZIP/Postal Code
64711
Country
Germany
Facility Name
Klinische Forschung Hannover-Mitte
City
Hannover
ZIP/Postal Code
30159
Country
Germany
Facility Name
ZSL Zentrum für medizinische Studien in Leipzig
City
Leipzig
ZIP/Postal Code
04157
Country
Germany
Facility Name
Praxis Dr. Pauls
City
München
ZIP/Postal Code
80331
Country
Germany
Facility Name
Praxis Dr. Kühn
City
Oranienburg
ZIP/Postal Code
16515
Country
Germany
Facility Name
Praxis Dr. Krause
City
Wolfratshausen
ZIP/Postal Code
82515
Country
Germany
Facility Name
Royal United Hospital
City
Bath
ZIP/Postal Code
BA1 3NG
Country
United Kingdom
Facility Name
Community Pharmacology Services (CPS)
City
Glasgow
ZIP/Postal Code
G20 0XA
Country
United Kingdom
Facility Name
Moorgreen Hospital
City
West End, Southampton
ZIP/Postal Code
SO30 3JB
Country
United Kingdom

12. IPD Sharing Statement

Citations:
Citation
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
Results Reference
result

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

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