Mild Cognitive Impairment (MCI)NCT01061489
Sensory-cognitive and Physical Fitness Training in Mild Cognitive Impairment
A study testing auditory discrimination training and physical movement training in people with Mild Cognitive Impairment (MCI) and Mild Alzheimer's Disease, run by University of Konstanz at 2 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Mild Cognitive Impairment (MCI), Mild Alzheimer's Disease
- What is being tested?
- auditory discrimination training and physical movement training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 2 sitesGermany
- Study dates
- Aug 2009to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
University of Konstanz
Konstanz, 78457
University of Ulm, Memory Clinic
Ulm, 89070
About this study
Official title: Computer-based Sensory-cognitive and Physical Fitness Training in Mild Cognitive Impairment (MCI) and Mild Alzheimer's Disease (AD)
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.
- Being tested
- auditory discrimination training, physical movement training
- Keywords
- neuroplasticity, Mild Cognitive Impairment (MCI), Alzheimer, sensory-cognitive training, physical fitness
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
auditory discrimination trainingOther
10-week neuroplasticity-based training (5 days/week, 1 hour each, PC-based), training at home
physical movement trainingOther
10-week training, small groups (2 days/week, 1 hour each) plus homework (3 days/week)
| Study group | Role | What they receive |
|---|---|---|
| sensory-cognitive training | Experimental | Not described Receives: Other: auditory discrimination training |
| physical fitness | Experimental | Not described Receives: Other: physical movement training |
| waiting list (control group) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: pre, post, 3-month follow-up
Secondary outcomes (1)
electrophysiological, MRI, blood and liquor correlates
Measured: pre, post, 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2010 (estimated)
- Study startAug 2009
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Konstanz
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ulm
- Responsible party
- Principal investigator, Iris-Tatjana Kolassa, University of Ulm
- Investigators
- Iris-Tatjana Kolassa, Prof. Dr., Study chair, Clinical and Biological Psychology, University of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01061489
- Sponsor's protocol ID
- WIN-Kol-09
- Status last verified
- Jul 2016
- First submitted
- 2 Feb 2010
- Last updated
- 14 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27608620
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-based Sensory-cognitive and Physical Fitness Training in Mild Cognitive Impairment (MCI) and Mild Alzheimer's Disease (AD)
- ClinicalTrials.gov ID
- NCT01061489
- Acronym / sponsor ID
- WIN-Kol-09
- Keywords
- neuroplasticity, Mild Cognitive Impairment (MCI), Alzheimer, sensory-cognitive training, physical fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of KonstanzUniversity, hospital or other
- Collaborators
- University of Ulm
- Study start
- Aug 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 3 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| sensory-cognitive training | Experimental | Other: auditory discrimination training |
| physical fitness | Experimental | Other: physical movement training |
| waiting list (control group) | No intervention | – |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| auditory discrimination training10-week neuroplasticity-based training (5 days/week, 1 hour each, PC-based), training at home | Other | sensory-cognitive training |
| physical movement training10-week training, small groups (2 days/week, 1 hour each) plus homework (3 days/week) | Other | physical fitness |
Primary outcome
Change in global cognition
Time frame: 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).
1 secondary outcome
electrophysiological, MRI, blood and liquor correlates
Time frame: pre, post, 3-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2016.
- Derived from this study: PubMed 27608620Kuster 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iris-Tatjana Kolassa, Prof. Dr. study chair
Clinical and Biological Psychology, University of Ulm
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing auditory discrimination training and physical movement training in people with Mild Cognitive Impairment (MCI) and Mild Alzheimer's Disease, run by University of Konstanz at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in global cognition (time frame: pre, post, 3-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01061489, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2016.