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

November 11, 2014 updated by: Katharina Buerger, Ludwig-Maximilians - University of Munich

Outcome Predictors of a Complex Cognitive Intervention in Amnestic Mild Cognitive Impairment (aMCI)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Munich, Germany, 81377
        • Institute for Stroke and Dementia Research, Campus Grosshadern, Ludwig-Maximilian University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Consecutive aMCI patients of an University-based memory clinic

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in California Verbal Learning Test
Time Frame: month 0 and month 6
month 0 and month 6
Change in overall cognition (ADAScog)
Time Frame: month 0 and month 6
month 0 and month 6
Change in Face-Name Learning Test
Time Frame: month 0 and month 6
month 0 and month 6

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in appraisal of quality of life (SF-36)
Time Frame: month 0 and 6
month 0 and 6
Change in neurofunctional MRT (resting state fMRI)
Time Frame: month 0 and 6
month 0 and 6
Change in depression scores (Beck Depression Inventory)
Time Frame: month 0 and month 6
month 0 and month 6
Change in working memory (Digit Span)
Time Frame: month 0 and month 6
month 0 and month 6
Change in attention (Trail Making Test)
Time Frame: month 0 and month 6
month 0 and month 6
Change in executive functions (Stroop Test)
Time Frame: month 0 and month 6
month 0 and month 6
Change in neurostructural MRI (diffusion tensor imaging)
Time Frame: month 0 and month 6
month 0 and month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ludwig-Maximilians - University of Munich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (ACTUAL)

July 1, 2014

Study Completion (ACTUAL)

July 1, 2014

Study Registration Dates

First Submitted

January 24, 2012

First Submitted That Met QC Criteria

January 31, 2012

First Posted (ESTIMATE)

February 2, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

November 13, 2014

Last Update Submitted That Met QC Criteria

November 11, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • cogT002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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