NCT01061489

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 3, 2010

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

July 14, 2016

Status Verified

July 1, 2016

Enrollment Period

3.6 years

First QC Date

February 2, 2010

Last Update Submit

July 13, 2016

Conditions

Mild Cognitive Impairment (MCI)Mild Alzheimer's Disease

Keywords

neuroplasticityMild Cognitive Impairment (MCI)Alzheimersensory-cognitive trainingphysical fitness

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • electrophysiological, MRI, blood and liquor correlates

    pre, post, 3-month follow-up

Study Arms (3)

sensory-cognitive training

EXPERIMENTAL
Other: auditory discrimination training

physical fitness

EXPERIMENTAL
Other: physical movement training

waiting list (control group)

NO INTERVENTION

Interventions

auditory discrimination trainingOTHER

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

sensory-cognitive training
physical movement trainingOTHER

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

physical fitness

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Konstanz

Konstanz, 78457, Germany

Location

University of Ulm, Memory Clinic

Ulm, 89070, Germany

Location

Related Publications (1)

  • 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.

    PMID: 27608620DERIVED

Related Links

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Iris-Tatjana Kolassa, Prof. Dr.

    Clinical and Biological Psychology, University of Ulm

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Iris-Tatjana Kolassa

Study Record Dates

First Submitted

February 2, 2010

First Posted

February 3, 2010

Study Start

August 1, 2009

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

July 14, 2016

Record last verified: 2016-07

Locations

DE(2)