Efficacy of Cognitive Training in Subjective Memory Impairment

Study Overview
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Brief Summary
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This study evaluates the efficacy of cognitive training in subjects with subjective memory impairment. The first group will receive cognitive training and lifestyle modification in combination, the second group will receive only lifestyle modification, and the third group will receive no intervention.

Detailed Description
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Subjective memory impairment is currently thought to be a risky state of progression to Alzheimer's disease. This study aims to confirm whether cognitive training in subjective memory impairment would show improvement in the subjective and objective cognition. We include subjects with normal cognition but complained subjective feeling of memory decline and conduct cognitive training programs combined with lifestyle modifications for 3 months. We evaluate the neuropsychological tests and questionnaires about subjective improvement after 3 months of interventions.

Official Title
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A Prospective, Three-arm, Parallel Design, Controlled Trial to Assess Efficacy of Cognitive Training in Subjective Memory Impairment

Conditions
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Memory Loss

Intervention / Treatment
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* Behavioral: cognitive training
* Behavioral: lifestyle modification


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who showed normal range (above 16percentile of norm) in all domains of detailed neuropsychological tests battery named Seoul Neuropsychological Screening Battery (SNSB) Clinical dementia rating (CDR) score of 0 Subjects with at least 3 years of formal education Exclusion Criteria: Subjects with mild cognitive impairment or dementia Subjects who was diagnosed as any neurological disorders such as epilepsy, stroke, hemorrhage, hydrocephalus, Parkinson's disease or brain tumor Subjects with uncontrolled severe medical conditions according to investigator's opinion

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cognitive training<br>Cognitive training programs 2 times a week for 3 months (totally 24 sessions) for 90 minutes per session. Lifestyle modification is educated first, then weekly phone call for lifestyle modification is done by investigators. | Behavioral: cognitive training<br>* cognitive training is held 2 times a week for 3 months, 90 minutes per 1 session. It includes cognitive exercise of multiple cognitive domains such as memory, attention, calculation, executive function and visuospatial function.<br>Behavioral: lifestyle modification<br>* education about lifestyle modification is done by investigators at the first day of the trial and the investigators conduct weekly phone call to participants to educate the lifestyle modifications<br>|
| Active Comparator: lifestyle modification<br>This group receives only lifestyle modification for 3 months. Lifestyle modification is educated at the first, then weekly phone call for lifestyle modification is done by investigators. The method of lifestyle modification is same with the first arm. | Behavioral: lifestyle modification<br>* education about lifestyle modification is done by investigators at the first day of the trial and the investigators conduct weekly phone call to participants to educate the lifestyle modifications<br>|
| No Intervention: No intervention<br>This group receives no intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Paired associates learning test | paired associates learning test is a part of computerized neuropsychological tests battery named CANTAB (Cambridge Neuropsychological Test Automated Battery). The scores are shown as total number of errors. | 3 month | 
| Rapid visual information processing test | rapid visual information processing is a part of computerized neuropsychological test battery named CANTAB. The score is shown as correct response rate.% | 3 month | 
| Pattern recognition memory test | paired associates learning test is a part of computerized neuropsychological tests battery named CANTAB (Cambridge Neuropsychological Test Automated Battery). The score is shown as correct response rate.% | 3 month | 
| Spatial working memory test | paired associates learning test is a part of computerized neuropsychological tests battery named CANTAB (Cambridge Neuropsychological Test Automated Battery). The scores are shown as total number of errors. | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cognitive failure questionnaire | questionnaire for measuring self reported cognitive status. score range: 0-100. Higher score means worse cognitive status. | 3 month | 
| Mini-mental state examination | mini-mental state examination that examines general cognition. range 0-20. Higher score means better cognition. | 3 month | 
| Geriatric depression scale | questionnaire for depression measuring. score range:0-15. lower score means less depression. | 3 month | 
| Beck anxiety index | questionnaire for self reporting anxiety measuring. range:0-63. low score means less anxiety. | 3 month | 
| Seoul instrumental activities of daily living | scale for measuring activities of daily living limitation. score range 0-45. low score means better ability. | 3 month | 
| Rey complex figure copy test | test for visuospatial function. Participants should copy the complex figure. score range: 0-36. Higher score means better visuospatial function. | 3 month | 
| Digit symbol test | a test for attention and psychomotor speed. Participants are instructed to write an appropriately matched code for each number. Correct number is counted. score range: 0-76. Higher score means better function. | 3 month | 
| Seoul verbal learning test, immediate recall | measuring tool for immediate memory function. Investigators read 12 words to participants. Participants should remember the words. Tests are done 3 times. score range: 0-36. Higher score means better immediate memory function | 3 month | 
| Seoul verbal learning test, delayed recall | measuring tool for 20 minutes delayed memory function. After 20 minutes from the immediate recall test, participants should remember the words. score range: 0-12. Higher score means better delayed memory function | 3 month | 
| Seoul verbal learning test, delayed recall | measuring tool for cued recall of verbal memory function. score range: 0-24. 2. Higher score means better memory recognition function | 3 month | 
| Logical memory test, delayed recall | logical memory test is a part of a neuropsychological test named Wechsler | 3 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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subjective memory impairment, cognitive training