Sensory-cognitive and Physical Fitness Training in Mild Cognitive Impairment

Study Overview
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Brief Summary
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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.

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

Conditions
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Mild Cognitive Impairment (MCI), Mild Alzheimer's Disease

Intervention / Treatment
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* Other: auditory discrimination training
* Other: physical movement training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sensory-cognitive training<br> | Other: auditory discrimination training<br>* 10-week neuroplasticity-based training (5 days/week, 1 hour each, PC-based), training at home<br>|
| Experimental: physical fitness<br> | Other: physical movement training<br>* 10-week training, small groups (2 days/week, 1 hour each) plus homework (3 days/week)<br>|
| No Intervention: waiting list (control group)<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in global cognition | 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). | pre, post, 3-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| electrophysiological, MRI, blood and liquor correlates |  | pre, post, 3-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neuroplasticity, Mild Cognitive Impairment (MCI), Alzheimer, sensory-cognitive training, physical fitness