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OpenTrials
Completed

NCT Number: NCT01061489

Sensory-cognitive and Physical Fitness Training in Mild Cognitive Impairment

Age-related cognitive decline is unavoidable. However, recent results of neuroplasticity-based research show that neuroplasticity-based training and physical activity might have the potential to decelerate or even reverse effects of aging and age-related cognitive impairments. Little is known whether these results also apply to pathological processes of aging such as mild cognitive impairment (MCI) and dementia.

This multi-center study aims at investigating efficiency and feasibility of a neuroplasticity-based auditory discrimination training and a physical fitness training for patients suffering from mild cognitive impairment or mild Alzheimer's disease (Mini Mental State Examination, MMSE > 19). Evaluation will include neuropsychological testing, electroencephalography (EEG) and magnetic resonance imaging (MRI) measurements as well as blood and liquor analyses.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Konstanz, Konstanz, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • focus: subjective and/or objective memory complaints with MMSE > 19 (MCI or mild Alzheimer's Disease, with stable medication for at least 3 months)
  • mild to moderate depression
  • corrected-to-normal hearing and vision
  • for MRI: non-magnetic metals inside the body
  • right handedness preferred

Exclusion criteria

  • cognitive impairment/ dementia with MMSE < 20, severe psychiatric or neurological disease (current and lifetime)
  • physical health that does not allow physical fitness tests and trainings
  • benzodiazepin, tricyclic antidepressants
  • for MRI: magnetic metal inside the body, cardiac pacemaker etc.
  • for liquor: insufficient blood coagulation, insufficient brain pressure

Treatment and study plan

auditory discrimination training

Other

10-week neuroplasticity-based training (5 days/week, 1 hour each, PC-based), training at home

physical movement training

Other

10-week training, small groups (2 days/week, 1 hour each) plus homework (3 days/week)

Primary outcomes

  1. Change in global cognition

    Time frame: pre, post, 3-month follow-up

    Average score of the two component scores "memory" and "attention / executive functions", derived from principal component analysis of 11 cognitive items (Munich verbal memory test (MVGT) encoding, MVGT long delayed free recall, free recall of the Alzheimer's Disease Assessment Scale, working memory in the Everyday Cognition Battery, Trail Making Test A and B, digit span forward and backward, digit-symbol-coding and semantic and phonematic fluency).

Secondary outcomes

  1. electrophysiological, MRI, blood and liquor correlates

    Time frame: pre, post, 3-month follow-up

Sponsors and collaborators

Lead sponsor

University of Konstanz

Other

Collaborators

  • University of Ulm

Registry information

Official study title

Computer-based Sensory-cognitive and Physical Fitness Training in Mild Cognitive Impairment (MCI) and Mild Alzheimer's Disease (AD)

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Feb 3, 2010
Registry last updated
Jul 14, 2016

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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