Memory Aid - Working Memory Training in Patients With Mild Cognitive Impairment. (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: NCT01991405
Recruitment Status : Unknown
Verified May 2014 by Sorlandet Hospital HF.
Recruitment status was:  Recruiting
First Posted : November 25, 2013
Last Update Posted : May 23, 2014
Information provided by (Responsible Party):
Sorlandet Hospital HF

Brief Summary:


Mild Cognitive Impairment (MCI) is a condition characterized by memory problems more severe than normal cognitive changes due to old age, and less severe than dementia. Reduced working memory (WM) is regarded as one of the core symptoms of an MCI-condition. Recent studies have indicated that WM can be improved trough computer based training.


The objective of the study is to evaluate if working memory training is effective in improving working memory in elderly MCI-patients. Further, to evaluate if cognitive training relates to structural changes in the white and gray matter of the brain, assessed by structural Magnetic Resonance Imaging. Cognitive phenotypes related to memory impairment and progression to dementia will also be investigated.

Patients and Methods:

The proposed study is a blinded, randomized and controlled trail that will include 90 elderly patients from a Memory Clinic diagnosed with MCI. The groups will be randomized to either training or a placebo version. The intervention is computerized working memory training performed for 45 minutes over 25 sessions. Neuropsychological assessment and structural MRI will be performed before, 6 and 12 months after training.


Currently there is no known treatment available for mild memory impairment/MCI, and few studies on specific cognitive training in MCI-patients have been performed. The proposed study has received funding from a Norwegian Health Region. If computer based training results in positive changes to memory functions in MCI patients this may represent a new, cost-effective treatment. Secondly, evaluation of training induced structural changes to grey or white matter may improve our understanding of the mechanisms behind effective cognitive interventions in MCI patients.

Condition or disease Intervention/treatment
Mild Cognitive Impairment Device: Computerized Working Memory Training.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Memory Aid - Computer Based Working Memory Training in Elderly With Mild Cognitive Impairment (MCI). A Randomized, Controlled Trial.
Study Start Date : August 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory
U.S. FDA Resources

Arm Intervention/treatment
Sham Comparator: Computerized Working Memory Training.
The Working Memory Training, includes both auditive and visual tasks, administrated on a computer, under guidance. 5 x 45 minutes per week, for 5 weeks. The placebo group will train at an fixed level (non-adaptive), but with otherwise identical computer programs.
Device: Computerized Working Memory Training.
Auditive and visual Working Memory tasks, administrated on a computer under guidance. 5 x 45 minutes per week, for 5 weeks. The intervention group will train at an "adaptive" level that is not to difficult nor to easy, which is hypothesized as optimal for learning and training effect. The placebo group will train with a "sham" program that is fixed ("non-adaptive" in difficulty level), but otherwise identical.
Other Name: Cogmed (r) from Pearson Assessment Inc.

Primary Outcome Measures :
  1. Working Memory function. [ Time Frame: Changes from baseline (3, 6 and 12 months after intervention). ]
    The study seeks to assess changes in the patients working memory function after an intervention of working memory training.The construct of "Working Memory" is measured on several levels: by neuropsychological tests (cognitive level), assessment of daily living skills (ADL-level), and measures of changes in the brains white and gray matter in areas that are correlated with working memory function (brain level).

Secondary Outcome Measures :
  1. Episodic memory function. [ Time Frame: Changes from baseline (3, 6 and 12 months after intervention). ]
    We will measure the patients results on a word list task, both immediate and delayed recall, as well as recognition. Low scores on word list learning is associated with progression to dementia. It is anticipated that patients with MCI are at risk for developing dementia. The study seeks to investigate if there is a correlation between the results on memory tests and progression to dementia in this patient group.

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients who meet the Peterson diagnostic criteria of MCI:

    1. memory complaints (preferably confirmed by an informant).
    2. memory impairment according to age and education.
    3. preserved general cognitive function.
    4. intact activities of daily living, absence of dementia.

Exclusion Criteria:

  • head trauma with post-traumatic loss of conscience for 30 minutes during lifespan.
  • loss of senses (blindness, deafness).
  • photo-sensitive epilepsy.
  • unsuitability for Magnetic Resonance Imaging-examination due to metal foreign bodies or severe claustrophobia.
  • drug and/or alcohol abuse.

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): NCT01991405

Contact: Gro C Løhaugen, PhD 0047-95844805

Sorlandet Hospital HF Recruiting
Arendal, Aust-Agder, Norway, 4838
Contact: Susanne S Hernes, MD    0047-48136020   
Sponsors and Collaborators
Sorlandet Hospital HF
Study Director: Svein Gunnar Gundersen, PhD Head of research department

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sorlandet Hospital HF Identifier: NCT01991405     History of Changes
Other Study ID Numbers: MCI Working Memory Training.
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: May 23, 2014
Last Verified: May 2014

Keywords provided by Sorlandet Hospital HF:
Mild Cognitive Impairment
Working Memory Training
Neuropsychological function in MCI

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