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

NCT ID: NCT01991405

Last Updated: 2014-05-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2016-12-31

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.

Conditions

Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: SHAM_COMPARATOR

Computerized Working Memory Training.

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Cogmed (r) from Pearson Assessment Inc.

Eligibility 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.

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sorlandet Hospital HF

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Svein Gunnar Gundersen, PhD

Role: STUDY_DIRECTOR

Head of research department

Locations

Sorlandet Hospital HF

Arendal, Aust-Agder, Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Gro C Løhaugen, PhD

Role: CONTACT

gro.c.lohaugen@ntnu.no

0047-95844805

Facility Contacts

Susanne S Hernes, MD

Role: primary

susanne.sorensen.hernes@sshf.no

0047-48136020

References

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.

Reference Type: DERIVED

PMID: 41029506 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24886034 (View on PubMed)

Other Identifiers

MCI Working Memory Training.

Identifier Type: -

Identifier Source: org_study_id