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

Primary Purpose

Mild Cognitive Impairment

Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Computerized Working Memory Training.
Sponsored by
Sorlandet Hospital HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Mild Cognitive Impairment, Working Memory Training, Neuropsychological function in MCI

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sorlandet Hospital HFRecruiting

Arms of the Study

Arm 1

Arm Type

Sham Comparator

Arm Label

Computerized Working Memory Training.

Arm Description

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.

Outcomes

Primary Outcome Measures

Working Memory function.
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.
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.

Full Information

First Posted
November 18, 2013
Last Updated
May 22, 2014
Sponsor
Sorlandet Hospital HF
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1. Study Identification

Unique Protocol Identification Number
NCT01991405
Brief Title
Memory Aid - Working Memory Training in Patients With Mild Cognitive Impairment.
Acronym
MCI
Official Title
Memory Aid - Computer Based Working Memory Training in Elderly With Mild Cognitive Impairment (MCI). A Randomized, Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sorlandet Hospital HF

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Mild Cognitive Impairment, Working Memory Training, Neuropsychological function in MCI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Computerized Working Memory Training.
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Computerized Working Memory Training.
Other Intervention Name(s)
Cogmed (r) from Pearson Assessment Inc.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Working Memory function.
Description
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).
Time Frame
Changes from baseline (3, 6 and 12 months after intervention).
Secondary Outcome Measure Information:
Title
Episodic memory function.
Description
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.
Time Frame
Changes from baseline (3, 6 and 12 months after intervention).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who meet the Peterson diagnostic criteria of MCI: memory complaints (preferably confirmed by an informant). memory impairment according to age and education. preserved general cognitive function. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gro C Løhaugen, PhD
Phone
0047-95844805
Email
gro.c.lohaugen@ntnu.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Svein Gunnar Gundersen, PhD
Organizational Affiliation
Head of research department
Official's Role
Study Director
Facility Information:
Facility Name
Sorlandet Hospital HF
City
Arendal
State/Province
Aust-Agder
ZIP/Postal Code
4838
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susanne S Hernes, MD
Phone
0047-48136020
Email
susanne.sorensen.hernes@sshf.no

12. IPD Sharing Statement

Citations:
PubMed Identifier
24886034
Citation
Flak MM, Hernes SS, Chang L, Ernst T, Douet V, Skranes J, Lohaugen GC. The Memory Aid study: protocol for a randomized controlled clinical trial evaluating the effect of computer-based working memory training in elderly patients with mild cognitive impairment (MCI). Trials. 2014 May 3;15:156. doi: 10.1186/1745-6215-15-156. Erratum In: Trials. 2016;17:40. Chang, Linda; Ernst, Thomas; and Douet, Vanessa [Added].
Results Reference
derived

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

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