Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
110 participants
OBSERVATIONAL
2010-09-30
2014-07-31
Brief Summary
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Previous studies indicate that not all patients respond equally well to a cognitive intervention. Identifying factors that predict response to treatment could help selecting patients for a targeted intervention. A potentially important predictor is cognitive reserve defined as premorbid cognitive performance. The hypothesis is that different levels of cognitive reserve (high cognitive reserve vs. low cognitive reserve) have different neurostructural and neurofunctional correlates and influence treatment response in a different way. Moreover, the impact of white matter lesions on treatment effects will be investigated.
The investigator will perform a complex cognitive training program. Forty patients with aMCI (20 with high cognitive reserve, 20 with low cognitive reserve) will be recruited in this study. Since the patients are recruited consecutively, an estimated overall number of 80 will be included and receive the training of whom about 40 will meet the inclusion criteria for our cognitive-reserve-study (high or low cognitive reserve). Data of the whole group will be used to analyze the potential impact of white matter lesions on response to the intervention. Cognitive effects of the intervention will be evaluated by neuropsychological testing. Neurofunctional and neurostructural changes depending on cognitive reserve will be measured using resting state fMRI and diffusion tensor imaging (DTI).
For comparison, a group of 30 aMCI patients will be recruited as an active control group receiving study investigations (neuropsychological testing as well as MRIs), and exercises for self-study at home, not the complex cognitive intervention.
Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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cognitive intervention group
cognitive intervention
Complex modular cognitive intervention focussing on memory aspects (e.g. internal memory strategies, external memory aids), other cognitive functions (e.g. attention) as well as social interactions.
active control group
No interventions assigned to this group
Interventions
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cognitive intervention
Complex modular cognitive intervention focussing on memory aspects (e.g. internal memory strategies, external memory aids), other cognitive functions (e.g. attention) as well as social interactions.
Eligibility Criteria
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Inclusion Criteria
* No evidence for other psychiatric axis I disorders according to DSM-IV criteria.
* No evidence for neurological disorders (e.g. stroke)
* No uncontrolled arterial hypertension or diabetes mellitus
* No history of drug / alcohol abuse
* The patient is able to provide written informed consent to participate in the study.
* for the cognitive-reserve-study patients, a high (low) cognitive reserve is defined as a verbal IQ score of \>/= 120 (\</= 110) as assessed by the MWT-B, a German multiple vocabulary test
Exclusion Criteria
* Uncontrolled arterial hypertension or diabetes mellitus
* History of drug / alcohol abuse
* No ability to participate and no willing to give informed consent and comply with the study restrictions.
ALL
No
Sponsors
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Ludwig-Maximilians - University of Munich
OTHER
Responsible Party
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Katharina Buerger
Katharina Buerger, MD, Institute for Stroke and Dementia Research
Locations
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Institute for Stroke and Dementia Research, Campus Grosshadern, Ludwig-Maximilian University
Munich, , Germany
Countries
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Other Identifiers
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cogT002
Identifier Type: -
Identifier Source: org_study_id