Efficacy Study of Cognitive Intervention in Amnestic Mild Cognitive Impairment
NCT ID: NCT01358955
Last Updated: 2013-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
293 participants
INTERVENTIONAL
2011-03-31
2013-01-31
Brief Summary
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* There will be a significant difference in cognitive function between a home-based cognitive intervention group and a wait list control group.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group cognitive intervention
The cognitive training will be administered twice a week for 12 weeks, located in hospital-based outpatient memory clinics. Each session will last approximately 90 minutes. The cognitive training programs will be offered in group sessions consisted of 5 participants.
group cognitive intervention
The cognitive training will be administered twice a week for 12 weeks, located in hospital-based outpatient memory clinics. Each session will last approximately 90 minutes. The cognitive training programs will be offered in group sessions consisted of 5 participants.
Home-based cognitive intervention
The participants will do their homework for 30 minutes every business days for 12 weeks.
Home-based cognitive intervention
The participants will do their paper and pencil homework for 30 minutes every business days for 12 weeks.
Wait list Control
They will participate in cognitive intervention after ending this study.
No interventions assigned to this group
Interventions
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group cognitive intervention
The cognitive training will be administered twice a week for 12 weeks, located in hospital-based outpatient memory clinics. Each session will last approximately 90 minutes. The cognitive training programs will be offered in group sessions consisted of 5 participants.
Home-based cognitive intervention
The participants will do their paper and pencil homework for 30 minutes every business days for 12 weeks.
Eligibility Criteria
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Inclusion Criteria
* memory complaint corroborated by a participant and an informant
* delayed recall score on the Seoul Verbal Learning Test (SVLT) below 1.0 standard deviations from the mean of the age and education-normative values among the Korean population
* Global CDR score is 0.5, Memory CDR score is 0.5 or 1.
* above 1.5 standard deviations from the mean of normative data of the respective age- and education-matched population on the Korean Mini-Mental State Examination
* normal functional activities
* not diagnosed with dementia
* Modified Hachinski Ischemic Score (HIS): 0-4
* brain magnetic resonance imaging or CT showing no clinical evidence of other diseases (i.e., normal pressure hydrocephalus, brain tumor, cerebrovascular disease) capable of producing cognitive impairment.
* Subjects are also required to have a reliable caregiver who meet the patient at least once a week and is sufficiently familiar with the patient to provide the investigator with accurate information.
* He/She can read and write
* written informed consent
Exclusion Criteria
* any patients with any severe or unstable medical disease that may prevent the patient from completing all study requirements (i.e., unstable or severe asthma or cardiovascular disease, active gastric ulcer, severe hepatic or renal disease)
* any patients with clinically significant laboratory abnormalities such as an abnormal thyroid function test, abnormal low level of vitamin B12 or folate, or positive venereal disease research laboratory test
* any patients with any primary neurodegenerative disorder or psychiatric disorder other than AD (i.e., Parkinson's disease, schizophrenia, or major depressive disorder)
* any patients with any history of drug or alcohol addiction during the past 10 years
* any hearing or visual impairment that can disturb the efficient evaluation of the patient
50 Years
85 Years
ALL
No
Sponsors
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Eisai Inc.
INDUSTRY
Inha University Hospital
OTHER
Responsible Party
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Chul Soo Kim
Professor
Principal Investigators
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Seong H Choi, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Inha University Hospital
Locations
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Korea University Medical College
Ansan, , South Korea
Soonchunhyang University Hospital
Bucheon-si, , South Korea
Bucheon St. Mary's Hospital, the Catholic University of Korea
Bucheon-si, , South Korea
Donga University Hospital
Busan, , South Korea
Pusan National University Hospital
Busan, , South Korea
Daejun Eulji University Hopistal
Daejun, , South Korea
Myongji Hospital
Goyang, , South Korea
NHIC Ilsan Hospital
Goyang, , South Korea
Inha Univeristy Hospital
Incheon, , South Korea
Jeju National University Hospital
Jeju City, , South Korea
Maryknoll Hospital
Pusan, , South Korea
Bobath Memorial Hospital
Seongnam, , South Korea
Sungkyunkwan University, Samsung Seoul Hospital
Seoul, , South Korea
Asan Medical Center, Psychiatry
Seoul, , South Korea
Inje University Sanggye Paik Hospital
Seoul, , South Korea
Konkuk University Medical Cener
Seoul, , South Korea
Ajou University Hospital
Suwon, , South Korea
Hyoja Geriatric Hospital
Yŏngin, , South Korea
Countries
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Other Identifiers
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CogMCI study
Identifier Type: -
Identifier Source: org_study_id