Outcome Predictors of a Cognitive Intervention in aMCI (OutPreC MCI)
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|ClinicalTrials.gov Identifier: NCT01525368|
Recruitment Status : Completed
First Posted : February 2, 2012
Last Update Posted : November 13, 2014
Cognitive training has been shown to be successful in patients with amnestic mild cognitive impairment (aMCI), a group at high-risk for Alzheimer's disease (AD). Moreover, in a randomized controlled trial, the investigators recently found that aMCI patients receiving a cognitive intervention showed stable hypometabolism in FDG-PET, whereas patients in an active control group showed pronounced hypometabolism on follow-up scans in regions typically affected in AD.
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.
|Condition or disease||Intervention/treatment|
|Amnestic Mild Cognitive Impairment||Behavioral: cognitive intervention|
|Study Type :||Observational|
|Actual Enrollment :||110 participants|
|Observational Model:||Case Control|
|Official Title:||Outcome Predictors of a Complex Cognitive Intervention in Amnestic Mild Cognitive Impairment (aMCI)|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
|cognitive intervention group||
Behavioral: 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|
- Change in California Verbal Learning Test [ Time Frame: month 0 and month 6 ]
- Change in overall cognition (ADAScog) [ Time Frame: month 0 and month 6 ]
- Change in Face-Name Learning Test [ Time Frame: month 0 and month 6 ]
- Change in appraisal of quality of life (SF-36) [ Time Frame: month 0 and 6 ]
- Change in neurofunctional MRT (resting state fMRI) [ Time Frame: month 0 and 6 ]
- Change in depression scores (Beck Depression Inventory) [ Time Frame: month 0 and month 6 ]
- Change in working memory (Digit Span) [ Time Frame: month 0 and month 6 ]
- Change in attention (Trail Making Test) [ Time Frame: month 0 and month 6 ]
- Change in executive functions (Stroop Test) [ Time Frame: month 0 and month 6 ]
- Change in neurostructural MRI (diffusion tensor imaging) [ Time Frame: month 0 and month 6 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01525368
|Institute for Stroke and Dementia Research, Campus Grosshadern, Ludwig-Maximilian University|
|Munich, Germany, 81377|