Clinical trial NCT01991405: Memory Aid - Working Memory Training in Patients With Mild Cognitive Impairment.
Official title: Memory Aid - Computer Based Working Memory Training in Elderly With Mild Cognitive Impairment (MCI). A Randomized, Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Mild Cognitive Impairment
Working Memory Training
Neuropsychological function in MCI
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
First posted: 2013-11-25
Enrollment: 90
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Working Memory function.
timeFrame: Changes from baseline (3, 6 and 12 months after intervention).
Secondary outcomes:
measure: Episodic memory function.
timeFrame: Changes from baseline (3, 6 and 12 months after intervention).
Other outcomes:
Locations:
city: Arendal
country: Norway
facility: Sorlandet Hospital HF
state: Aust-Agder
Study officials:
affiliation: Head of research department
name: Svein Gunnar Gundersen, PhD
role: STUDY_DIRECTOR
References:
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.