Mild Cognitive Impairment Clinical Trial
— MCIOfficial 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.
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.
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Norway | Sorlandet Hospital HF | Arendal | Aust-Agder |
Lead Sponsor | Collaborator |
---|---|
Sorlandet Hospital HF |
Norway,
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 |
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