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

Mild Cognitive Impairment Clinical Trial

— MCI  

Official title:

Memory Aid - Computer Based Working Memory Training in Elderly With Mild Cognitive Impairment (MCI). A Randomized, Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01991405
• Other study ID #: MCI Working Memory Training.
• Status: Recruiting
• Phase: N/A
• First received: November 18, 2013
• Last updated: May 22, 2014
• Start date: August 2013
• Est. completion date: December 2016

Study information

• Verified date: May 2014
• Source: Sorlandet Hospital HF
• Contact: Gro C Løhaugen, PhD
• Phone: 0047-95844805
• Email: gro.c.lohaugen[@]ntnu.no
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics Commitee
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Mild Cognitive Impairment

Intervention

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.

Locations

Country	Name	City	State
Norway	Sorlandet Hospital HF	Arendal	Aust-Agder

Sponsors (1)

Lead Sponsor	Collaborator
Sorlandet Hospital HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Changes from baseline (3, 6 and 12 months after intervention).	No
Secondary	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.	Changes from baseline (3, 6 and 12 months after intervention).	No