A Prospective, Three-arm, Parallel Design, Controlled Trial to Assess Efficacy of Cognitive Training in Subjective Memory Impairment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Asan Medical Center
- Enrollment
- 65
- Locations
- 1
- Primary Endpoint
- Pattern recognition memory test
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 55 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
cognitive training
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.
Intervention: cognitive training (Behavioral)
cognitive training
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.
Intervention: lifestyle modification (Behavioral)
lifestyle modification
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.
Intervention: lifestyle modification (Behavioral)
No intervention
This group receives no intervention.
Outcomes
Primary Outcomes
Pattern recognition memory test
Time Frame: 3 month
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
Time Frame: 3 month
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.
Paired associates learning test
Time Frame: 3 month
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
Time Frame: 3 month
rapid visual information processing is a part of computerized neuropsychological test battery named CANTAB. The score is shown as correct response rate.%
Secondary Outcomes
- Seoul verbal learning test, delayed recall(3 month)
- cognitive failure questionnaire(3 month)
- Beck anxiety index(3 month)
- Seoul instrumental activities of daily living(3 month)
- Rey complex figure copy test(3 month)
- Mini-mental state examination(3 month)
- Logical memory test, delayed recall(3 month)
- Seoul verbal learning test, immediate recall(3 month)
- Geriatric depression scale(3 month)
- Digit symbol test(3 month)
Investigators
Jae-Hong Lee
Professor
Asan Medical Center