NCT01261741

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
299

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2010

Shorter than P25 for phase_2

Geographic Reach
2 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 15, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 16, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

November 27, 2013

Status Verified

November 1, 2013

Enrollment Period

9 months

First QC Date

December 15, 2010

Last Update Submit

November 26, 2013

Conditions

Memory DisorderRetention Disorder, CognitiveSubjective Cognitive ImpairmentMemory, Concentration or Attention Problems

Outcome Measures

Primary Outcomes (1)

  • "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.

    12 weeks

Secondary Outcomes (4)

  • Change from baseline to visit 3 and 5 of Patient Global Impression of Change (PGI-C)

    16 weeks

  • Change from baseline to visit 4 in "Everyday Cognition 39" (ECog 39) total score

    12 weeks

  • Change from baseline to visit 4 in "Hospital Anxiety and Depression Scale" (HADS) Score

    12 weeks

  • Change from baseline to visit 3, 4, 5 of "Computer-based Neuropsychological Test Battery (C-NTB) by CogState Ltd.

    16 weeks

Study Arms (2)

Memantine

EXPERIMENTAL
Drug: Memantine

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

MemantineDRUG

Each subject will receive memantine 10mg tablets once daily

Memantine
PlaceboDRUG

Each subject will receive matching placebo tablets once daily

Placebo

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Universitätsklinikum der RWTH Aachen

Aachen, 52074, Germany

Location

Praxis Dr. Heidenreich

Böblingen, 71032, Germany

Location

Universitätsklinikum Carl Gustav Carus

Dresden, 01307, Germany

Location

Praxis Dr. Albrecht

Ellwangen, 73479, Germany

Location

Praxis Dr. Reifschneider

Erbach im Odenwald, 64711, Germany

Location

Klinische Forschung Hannover-Mitte

Hanover, 30159, Germany

Location

ZSL Zentrum für medizinische Studien in Leipzig

Leipzig, 04157, Germany

Location

Klinische Forschung Berlin-Mitte

Mitte, 10117, Germany

Location

Praxis Dr. Pauls

München, 80331, Germany

Location

Praxis Dr. Kühn

Oranienburg, 16515, Germany

Location

Praxis Dr. Krause

Wolfratshausen, 82515, Germany

Location

Royal United Hospital

Bath, BA1 3NG, United Kingdom

Location

Community Pharmacology Services (CPS)

Glasgow, G20 0XA, United Kingdom

Location

Moorgreen Hospital

West End, Southampton, SO30 3JB, United Kingdom

Location

Related Publications (1)

  • 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

    RESULT

MeSH Terms

Conditions

Memory Disorders

Interventions

Memantine

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AmantadineAdamantaneBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Merz Medical Expert

    Merz Pharmaceuticals GmbH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2010

First Posted

December 16, 2010

Study Start

November 1, 2010

Primary Completion

August 1, 2011

Study Completion

September 1, 2011

Last Updated

November 27, 2013

Record last verified: 2013-11

Locations

GB(3)DE(11)