Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00007858

Trial Description

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Title

Cognitive and motor training in mild cognitive impairment: an MRI study

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Although mild cognitive impairment is considered a risk factor for subsequent dementia of the Alzheimer type (AD), there is currently no drug treatment option. In this study, the influence of a combined memory and exercise training should be investigated for memory and attention processes in people with mild cognitive impairment.
The subjects were 12 weeks of cognitive-motor training undergone compared to a control group that did not train.
Further tasks should be handled at home. Before and after completion of the three-month training phase, a detailed neuropsychological testing of memory and attention performance was carried out.

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Brief Summary in Scientific Language

Memory dysfunction is the first and leading symptom of dementia of the Alzheimer type. In the context of improved early detection of the concept of mild cognitive impairment was introduced. This requires a subjective memory impairment that can be objectified in a cognitive test that exist in the absence of evidence of manifest dementia.
In addition to pharmacological therapies, there is a possibility of a cognitive intervention.
For this purpose, the effect of a 12-week combined memory and motor skills training was examined on memory performance in subjects with mild cognitive impairment:
- Impact on memory performance measured by a neuropsychological test battery.
- Impact on cortical morphology, structural integrity and functional plasticity as measured by MRI.
- The dependence of the observed changes of biological and genetic markers, such as homocysteine, apolipoprotein E phenotype Dopaminrezeptorpolymorphismen, asymmetric dimethylarginine (ADMA), brain-derived neurotrophic factor (BDNF) polymorphism and plasma levels.

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Organizational Data

  •   DRKS00007858
  •   2015/03/09
  •   [---]*
  •   yes
  •   Approved
  •   04/09, Ethikkommission der Medizinischen Fakultät der Otto-von-Guericke-Universität Magdeburg
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Secondary IDs

  •   U1111-1167-7319 
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Health Condition or Problem studied

  •   F06.7 -  Mild cognitive disorder
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Interventions/Observational Groups

  •   -20 Subjects with MCI: 12-week cognitive-motor training
    - 1 time weekly 120-135 min
  •   20 subjects with MCI: without 12-week cognitive-motor training
  •   21 healthy volunteers
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment, Other
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

- Episodic memory performance:

At the beginning and at the end of the training phase is detailed neuropsychological testing by VLMT (Verbal learning and memory test)

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Secondary Outcome

- BDNF plasma levels by ELISA:
At the beginning and at the end, and once after training

- Identification of the hippocampus volume by MRI:
at the beginning, after completion of the initial training period at 3 months and 6 months.

- Test for Attentional Performance: Rey-Osterrieth figure, logo test number range and block span, Verbal Fluency, Boston Naming Test, Trail-Making Test A and B, TAP

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2009/02/16
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   50   Years
  •   75   Years
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Additional Inclusion Criteria

- MCI

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Exclusion Criteria

- Probable dementia,

- History of severe diseases such as stroke or psychiatric disease,

- Treatment with antipsychotics and antidepressants,

- The existence of a relevant depressive mode with a value above 13 by the Beck Depression Inventory

- Unstable medical conditions

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinik für Neurologie
    • Mr.  Prof. Dr.  Hans-Jochen  Heinze 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Universitätsklinik für Neurologie
    • Mr.  Dr. med.  Daniel  Bittner 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Universitätsklinik für Neurologie
    • Mr.  Dr. med.  Daniel  Bittner 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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Sources of Monetary or Material Support

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    • FAN GmbHZenit Technologie-Park
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    •   +49-391-6263-437
    •   +49-391-6263-438
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2011/03/31
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Trial Publications, Results and other Documents

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