Outcome Predictors of a Cognitive Intervention in aMCI (OutPreC MCI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01525368
Recruitment Status : Completed
First Posted : February 2, 2012
Last Update Posted : November 13, 2014
Information provided by (Responsible Party):
Katharina Buerger, Ludwig-Maximilians - University of Munich

Brief Summary:

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
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. Change in California Verbal Learning Test [ Time Frame: month 0 and month 6 ]
  2. Change in overall cognition (ADAScog) [ Time Frame: month 0 and month 6 ]
  3. Change in Face-Name Learning Test [ Time Frame: month 0 and month 6 ]

Secondary Outcome Measures :
  1. Change in appraisal of quality of life (SF-36) [ Time Frame: month 0 and 6 ]
  2. Change in neurofunctional MRT (resting state fMRI) [ Time Frame: month 0 and 6 ]
  3. Change in depression scores (Beck Depression Inventory) [ Time Frame: month 0 and month 6 ]
  4. Change in working memory (Digit Span) [ Time Frame: month 0 and month 6 ]
  5. Change in attention (Trail Making Test) [ Time Frame: month 0 and month 6 ]
  6. Change in executive functions (Stroop Test) [ Time Frame: month 0 and month 6 ]
  7. Change in neurostructural MRI (diffusion tensor imaging) [ Time Frame: month 0 and month 6 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Consecutive aMCI patients of an University-based memory clinic

Inclusion Criteria:

  • male or female patients, fulfilling Petersen´s criteria of amnestic mild cognitive impairment (aMCI)
  • 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:

  • Evidence for acute psychiatric or neurological disorders
  • 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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01525368

Institute for Stroke and Dementia Research, Campus Grosshadern, Ludwig-Maximilian University
Munich, Germany, 81377
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich

Responsible Party: Katharina Buerger, Katharina Buerger, MD, Institute for Stroke and Dementia Research, Ludwig-Maximilians - University of Munich Identifier: NCT01525368     History of Changes
Other Study ID Numbers: cogT002
First Posted: February 2, 2012    Key Record Dates
Last Update Posted: November 13, 2014
Last Verified: November 2014

Keywords provided by Katharina Buerger, Ludwig-Maximilians - University of Munich:
mild cognitive impairment
Alzheimer's disease
cognitive intervention
cognitive reserve

Additional relevant MeSH terms:
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders