Clinical trial NCT01061489: Sensory-cognitive and Physical Fitness Training in Mild Cognitive Impairment
Official title: Computer-based Sensory-cognitive and Physical Fitness Training in Mild Cognitive Impairment (MCI) and Mild Alzheimer's Disease (AD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment (MCI)
Mild Alzheimer's Disease
Keywords: neuroplasticity
Mild Cognitive Impairment (MCI)
Alzheimer
sensory-cognitive training
physical fitness
Lead sponsor: University of Konstanz
Sponsor class: OTHER
Collaborators: name: University of Ulm
First posted: 2010-02-03
Enrollment: 65
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in global cognition
timeFrame: pre, post, 3-month follow-up
Secondary outcomes:
measure: electrophysiological, MRI, blood and liquor correlates
timeFrame: pre, post, 3-month follow-up
Other outcomes:
Locations:
city: Konstanz
country: Germany
facility: University of Konstanz
city: Ulm
country: Germany
facility: University of Ulm, Memory Clinic
Study officials:
affiliation: Clinical and Biological Psychology, University of Ulm
name: Iris-Tatjana Kolassa, Prof. Dr.
role: STUDY_CHAIR
References:
citation: Kuster OC, Fissler P, Laptinskaya D, Thurm F, Scharpf A, Woll A, Kolassa S, Kramer AF, Elbert T, von Arnim CA, Kolassa IT. Cognitive change is more positively associated with an active lifestyle than with training interventions in older adults at risk of dementia: a controlled interventional clinical trial. BMC Psychiatry. 2016 Sep 8;16(1):315. doi: 10.1186/s12888-016-1018-z.