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

This study is currently recruiting participants.
Verified February 2012 by Ludwig-Maximilians - University of Munich
Sponsor:
Information provided by (Responsible Party):
Katharina Buerger, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT01525368
First received: January 24, 2012
Last updated: February 6, 2012
Last verified: February 2012
History of Changes
  Purpose

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).


Condition Intervention
Amnestic Mild Cognitive Impairment
 Behavioral: cognitive intervention

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Outcome Predictors of a Complex Cognitive Intervention in Amnestic Mild Cognitive Impairment (aMCI)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:
  • Change in California Verbal Learning Test [ Time Frame: month 0 and month 6 ] [ Designated as safety issue: No ]
  • Change in overall cognition (ADAScog) [ Time Frame: month 0 and month 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in appraisal of quality of life (SF-36) [ Time Frame: month 0 and 6 ] [ Designated as safety issue: No ]
  • Change in neurofunctional MRT (resting state fMRI) [ Time Frame: month 0 and 6 ] [ Designated as safety issue: No ]
  • Change in depression scores (Beck Depression Inventory) [ Time Frame: month 0 and month 6 ] [ Designated as safety issue: No ]
  • Change in working memory (Digit Span) [ Time Frame: month 0 and month 6 ] [ Designated as safety issue: No ]
  • Change in attention (Trail Making Test) [ Time Frame: month 0 and month 6 ] [ Designated as safety issue: No ]
  • Change in executive functions (Stroop Test) [ Time Frame: month 0 and month 6 ] [ Designated as safety issue: No ]
  • Change in neurostructural MRI (diffusion tensor imaging) [ Time Frame: month 0 and month 6 ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: September 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cognitive intervention 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01525368

Contacts
Contact: Katharina Buerger, MD +49 89 7095 8316 katharina.buerger@med.uni-muenchen.de

Locations
Germany
Institute for Stroke and Dementia Research, Campus Grosshadern, Ludwig-Maximilian University Recruiting
Munich, Germany, 81377
Contact: Martin Dichgans, MD     +49 89 7095 7801     martin.dichgans@med.uni-muenchen.de    
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
  More Information

No publications provided

Responsible Party: Katharina Buerger, Katharina Buerger, MD, Institute for Stroke and Dementia Research, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT01525368     History of Changes
Other Study ID Numbers: cogT002
Study First Received: January 24, 2012
Last Updated: February 6, 2012
Health Authority: Germany: Federal Ministry of Food, Agriculture and Consumer Protection

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

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013