Sensory-cognitive and Physical Fitness Training in Mild Cognitive Impairment

Not Applicable

Completed

• Conditions: Mild Alzheimer's Disease; Mild Cognitive Impairment (MCI)
• Interventions: Other: auditory discrimination training; Other: physical movement training

• Registration Number: NCT01061489
• Lead Sponsor: University of Konstanz

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2010-02-02
• Study First Submitted QC: 2010-02-02
• Study First Posted: 2010-02-03
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-13
• Last Update Posted: 2016-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sensory-cognitive training	auditory discrimination training	-
physical fitness	physical movement training	-

Primary Outcome Measures

Name	Time	Method
Change in global cognition	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 Outcome Measures

Name	Time	Method
electrophysiological, MRI, blood and liquor correlates	pre, post, 3-month follow-up

Trial Locations

Locations (2)

University of Ulm, Memory Clinic; 🇩🇪 Ulm, Germany

University of Konstanz; 🇩🇪 Konstanz, Germany