Mild Cognitive ImpairmentMCINCT01991405
Memory Aid - Working Memory Training in Patients With Mild Cognitive Impairment.
A study testing Computerized Working Memory Training. in people with Mild Cognitive Impairment, run by Sorlandet Hospital HF at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Computerized Working Memory Training.
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2013to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Sorlandet Hospital HF
Arendal, Aust-Agder, 4838
Susanne S Hernes, MD, 0047-48136020, susanne.sorensen.hernes@sshf.no
About this study
Official title: Memory Aid - Computer Based Working Memory Training in Elderly With Mild Cognitive Impairment (MCI). A Randomized, Controlled Trial.
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.
Read more
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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Computerized Working Memory Training.
- Keywords
- Mild Cognitive Impairment, Working Memory Training, Neuropsychological function in MCI
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized Working Memory Training.Device
Also called Cogmed (r) from Pearson Assessment Inc.
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.
| Study group | Role | What they receive |
|---|---|---|
| Computerized Working Memory Training. | Sham comparator | 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. Receives: Device: Computerized Working Memory Training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Changes from baseline (3, 6 and 12 months after intervention).
Secondary outcomes (1)
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.
Measured: Changes from baseline (3, 6 and 12 months after intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Svein Gunnar Gundersen, PhD, Study director, Head of research department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01991405
- Sponsor's protocol ID
- MCI Working Memory Training.
- Acronym
- MCI
- Status last verified
- May 2014
- First submitted
- 18 Nov 2013
- Last updated
- 23 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Nordnes PR, Edwin TH, Flak MM, Lohaugen GCC, Skranes J, Chang L, Hol HR, Ulstein I, Hernes SS. The effect of working memory training on patient and informant reported executive function in mild cognitive impairment: an interventional study. BMC Neurol. 2025 Sep 30;25(1):404. doi: 10.1186/s12883-025-04381-4.
PubMed 41029506Flak 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.
PubMed 24886034
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Memory Aid - Computer Based Working Memory Training in Elderly With Mild Cognitive Impairment (MCI). A Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT01991405
- Acronym / sponsor ID
- MCI / MCI Working Memory Training.
- Conditions
- Mild Cognitive Impairment
- Keywords
- Mild Cognitive Impairment, Working Memory Training, Neuropsychological function in MCI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sorlandet Hospital HFOther government
- Study start
- Aug 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Computerized Working Memory Training. | Sham comparator | Device: 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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who meet the Peterson diagnostic criteria of MCI:
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computerized Working Memory Training.Also: Cogmed (r) from Pearson Assessment Inc.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. | Device | Computerized Working Memory Training. |
Primary outcome
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).
1 secondary outcome
Episodic memory function.
Time frame: Changes from baseline (3, 6 and 12 months after intervention).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2014.
- Derived from this study: PubMed 41029506Nordnes PR, Edwin TH, Flak MM, Lohaugen GCC, Skranes J, Chang L, Hol HR, Ulstein I, Hernes SS. The effect of working memory training on patient and informant reported executive function in mild cognitive impairment: an interventional study. BMC Neurol. 2025 Sep 30;25(1):404. doi: 10.1186/s12883-025-04381-4.
- Derived from this study: PubMed 24886034Flak 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Svein Gunnar Gundersen, PhD study director
Head of research department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized Working Memory Training. in people with Mild Cognitive Impairment, run by Sorlandet Hospital HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gro C Løhaugen, PhD (0047-95844805, gro.c.lohaugen@ntnu.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Working Memory function. (time frame: Changes from baseline (3, 6 and 12 months after intervention).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01991405, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2014.