Memory Aid - Working Memory Training in Patients With Mild Cognitive Impairment. (MCI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Sorlandet Hospital HF
Sponsor:
Information provided by (Responsible Party):
Sorlandet Hospital HF
ClinicalTrials.gov Identifier:
NCT01991405
First received: November 18, 2013
Last updated: May 22, 2014
Last verified: May 2014
  Purpose

Background:

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.

Objectives:

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.

Relevance:

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 Intervention
Mild Cognitive Impairment
Device: Computerized Working Memory Training.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (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.

Resource links provided by NLM:


Further study details as provided by Sorlandet Hospital HF:

Primary Outcome Measures:
  • Working Memory function. [ Time Frame: Changes from baseline (3, 6 and 12 months after intervention). ] [ Designated as safety issue: No ]
    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:
  • Episodic memory function. [ Time Frame: Changes from baseline (3, 6 and 12 months after intervention). ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 90
Study Start Date: August 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01991405

Contacts
Contact: Gro C Løhaugen, PhD 0047-95844805 gro.c.lohaugen@ntnu.no

Locations
Norway
Sorlandet Hospital HF Recruiting
Arendal, Aust-Agder, Norway, 4838
Contact: Susanne S Hernes, MD    0047-48136020    susanne.sorensen.hernes@sshf.no   
Sponsors and Collaborators
Sorlandet Hospital HF
Investigators
Study Director: Svein Gunnar Gundersen, PhD Head of research department
  More Information

No publications provided by Sorlandet Hospital HF

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sorlandet Hospital HF
ClinicalTrials.gov Identifier: NCT01991405     History of Changes
Other Study ID Numbers: MCI Working Memory Training.
Study First Received: November 18, 2013
Last Updated: May 22, 2014
Health Authority: Norway: Regional Ethics Commitee

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

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

ClinicalTrials.gov processed this record on August 28, 2014