Back to resultsEfficacy of Cognitive Training in Subjective Memory Impairment
Primary Purpose
Memory Loss
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
cognitive training
lifestyle modification
Sponsored by
About this trial
This is an interventional treatment trial for Memory Loss focused on measuring subjective memory impairment, cognitive training
Eligibility Criteria
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
Sites / Locations
- Jae-Hong Lee
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
cognitive training
lifestyle modification
No intervention
Arm Description
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.
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.
This group receives no intervention.
Outcomes
Primary Outcome Measures
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.
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.%
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.%
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.
Secondary Outcome Measures
cognitive failure questionnaire
questionnaire for measuring self reported cognitive status. score range: 0-100. Higher score means worse cognitive status.
Mini-mental state examination
mini-mental state examination that examines general cognition. range 0-20. Higher score means better cognition.
Geriatric depression scale
questionnaire for depression measuring. score range:0-15. lower score means less depression.
Beck anxiety index
questionnaire for self reporting anxiety measuring. range:0-63. low score means less anxiety.
Seoul instrumental activities of daily living
scale for measuring activities of daily living limitation. score range 0-45. low score means better ability.
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.
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.
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
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
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
Logical memory test, delayed recall
logical memory test is a part of a neuropsychological test named Wechsler
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02555774
Brief Title
Efficacy of Cognitive Training in Subjective Memory Impairment
Official Title
A Prospective, Three-arm, Parallel Design, Controlled Trial to Assess Efficacy of Cognitive Training in Subjective Memory Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Memory Loss
Keywords
subjective memory impairment, cognitive training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cognitive training
Arm Type
Experimental
Arm Description
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.
Arm Title
lifestyle modification
Arm Type
Active Comparator
Arm Description
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.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
This group receives no intervention.
Intervention Type
Behavioral
Intervention Name(s)
cognitive training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
lifestyle modification
Intervention Description
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
Primary Outcome Measure Information:
Title
Paired associates learning test
Description
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.
Time Frame
3 month
Title
Rapid visual information processing test
Description
rapid visual information processing is a part of computerized neuropsychological test battery named CANTAB. The score is shown as correct response rate.%
Time Frame
3 month
Title
Pattern recognition memory test
Description
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.%
Time Frame
3 month
Title
Spatial working memory test
Description
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.
Time Frame
3 month
Secondary Outcome Measure Information:
Title
cognitive failure questionnaire
Description
questionnaire for measuring self reported cognitive status. score range: 0-100. Higher score means worse cognitive status.
Time Frame
3 month
Title
Mini-mental state examination
Description
mini-mental state examination that examines general cognition. range 0-20. Higher score means better cognition.
Time Frame
3 month
Title
Geriatric depression scale
Description
questionnaire for depression measuring. score range:0-15. lower score means less depression.
Time Frame
3 month
Title
Beck anxiety index
Description
questionnaire for self reporting anxiety measuring. range:0-63. low score means less anxiety.
Time Frame
3 month
Title
Seoul instrumental activities of daily living
Description
scale for measuring activities of daily living limitation. score range 0-45. low score means better ability.
Time Frame
3 month
Title
Rey complex figure copy test
Description
test for visuospatial function. Participants should copy the complex figure. score range: 0-36. Higher score means better visuospatial function.
Time Frame
3 month
Title
Digit symbol test
Description
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.
Time Frame
3 month
Title
Seoul verbal learning test, immediate recall
Description
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
Time Frame
3 month
Title
Seoul verbal learning test, delayed recall
Description
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
Time Frame
3 month
Title
Seoul verbal learning test, delayed recall
Description
measuring tool for cued recall of verbal memory function. score range: 0-24. 2. Higher score means better memory recognition function
Time Frame
3 month
Title
Logical memory test, delayed recall
Description
logical memory test is a part of a neuropsychological test named Wechsler
Time Frame
3 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae-Hong Lee, MD,PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jae-Hong Lee
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
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Efficacy of Cognitive Training in Subjective Memory Impairment
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