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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02555774
Other study ID # YJeongHong
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2014
Est. completion date February 2016

Study information

Verified date August 2018
Source Asan Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 65
Est. completion date February 2016
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender All
Age group 55 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
cognitive training
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.
lifestyle modification
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

Locations

Country Name City State
Korea, Republic of Jae-Hong Lee Seoul

Sponsors (1)

Lead Sponsor Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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 cognitive failure questionnaire questionnaire for measuring self reported cognitive status. score range: 0-100. Higher score means worse cognitive status. 3 month
Secondary Mini-mental state examination mini-mental state examination that examines general cognition. range 0-20. Higher score means better cognition. 3 month
Secondary Geriatric depression scale questionnaire for depression measuring. score range:0-15. lower score means less depression. 3 month
Secondary Beck anxiety index questionnaire for self reporting anxiety measuring. range:0-63. low score means less anxiety. 3 month
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Logical memory test, delayed recall logical memory test is a part of a neuropsychological test named Wechsler 3 month
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