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Completed

NCT Number: NCT01525368

Outcome Predictors of a Cognitive Intervention in 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.

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Key information

Conditions

Amnestic Mild Cognitive Impairment Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute for Stroke and Dementia Research, Campus Grosshadern, Ludwig-Maximilian University

Munich, 81377, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cognitive intervention

Behavioral

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Registry information

Official study title

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

Acronym: OutPreC MCI

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Feb 2, 2012
Registry last updated
Nov 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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