Sensory-cognitive and Physical Fitness Training in Mild Cognitive Impairment

Mild Cognitive Impairment (MCI) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01061489
• Other study ID #: WIN-Kol-09
• Status: Completed
• Phase: N/A
• First received: February 2, 2010
• Last updated: July 13, 2016
• Start date: August 2009
• Est. completion date: March 2013

Study information

• Verified date: July 2016
• Source: University of Konstanz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognition Disorders
• Mild Alzheimer's Disease
• Mild Cognitive Impairment
• Mild Cognitive Impairment (MCI)

Intervention

Other:
• auditory discrimination training
10-week neuroplasticity-based training (5 days/week, 1 hour each, PC-based), training at home
• physical movement training
10-week training, small groups (2 days/week, 1 hour each) plus homework (3 days/week)

Locations

Country	Name	City	State
Germany	University of Konstanz	Konstanz
Germany	University of Ulm, Memory Clinic	Ulm

Sponsors (2)

Lead Sponsor	Collaborator
University of Konstanz	University of Ulm

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	electrophysiological, MRI, blood and liquor correlates		pre, post, 3-month follow-up	No

External Links

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