Back to resultsEfficacy Study of Cognitive Intervention in Amnestic Mild Cognitive Impairment (CogMCI)
Primary Purpose
Mild Cognitive Impairment
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
group cognitive intervention
Home-based cognitive intervention
Sponsored by
About this trial
This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring mild cognitive impairment, cognitive therapy, prevention
Eligibility Criteria
Inclusion Criteria:
- 50 to 85 years of age
- 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 patient who were involved in other clinical trials or treated with experimental drug within 4 weeks
- 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
Sites / Locations
- Korea University Medical College
- Soonchunhyang University Hospital
- Bucheon St. Mary's Hospital, the Catholic University of Korea
- Donga University Hospital
- Pusan National University Hospital
- Daejun Eulji University Hopistal
- Myongji Hospital
- NHIC Ilsan Hospital
- Inha Univeristy Hospital
- Jeju National University Hospital
- Maryknoll Hospital
- Bobath Memorial Hospital
- Sungkyunkwan University, Samsung Seoul Hospital
- Asan Medical Center, Psychiatry
- Inje University Sanggye Paik Hospital
- Konkuk University Medical Cener
- Ajou University Hospital
- Hyoja Geriatric Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
Group cognitive intervention
Home-based cognitive intervention
Wait list Control
Arm Description
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.
The participants will do their homework for 30 minutes every business days for 12 weeks.
They will participate in cognitive intervention after ending this study.
Outcomes
Primary Outcome Measures
Modified Alzheimer's Disease Assessment Scale-Cognitive subscale(ADAS-cog)
Secondary Outcome Measures
story recall test
Digit span forward and backward
Word fluency test
color-word stroop test
Digit symbol test
prospective memory test
Mini-Mental State Examination
CDR-SB
K-AD8
PRMQ
MMQ-Strategy
QOL-AD
Geriatric Depression Scale-short form
Bayer ADL
CGA-NPI
Subjective cognitive assessment
Full Information
NCT ID
NCT01358955
First Posted
May 20, 2011
Last Updated
August 27, 2013
Sponsor
Inha University Hospital
Collaborators
Eisai Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01358955
Brief Title
Efficacy Study of Cognitive Intervention in Amnestic Mild Cognitive Impairment
Acronym
CogMCI
Official Title
A Multicenter, Randomized Trial to Assess Efficacy of Home-based and Group Cognitive Intervention Programs in Amnestic Mild Cognitive Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inha University Hospital
Collaborators
Eisai Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
There will be a significant difference in cognitive function between cognitive intervention group (group therapy) and a wait list control group.
There will be a significant difference in cognitive function between a home-based cognitive intervention group and a wait list control group.
Detailed Description
The change of Modified ADAS-cog score from the baseline to post-intervention will be compared between the cognitive intervention group and wait list control group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
mild cognitive impairment, cognitive therapy, prevention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
293 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group cognitive intervention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Home-based cognitive intervention
Arm Type
Active Comparator
Arm Description
The participants will do their homework for 30 minutes every business days for 12 weeks.
Arm Title
Wait list Control
Arm Type
No Intervention
Arm Description
They will participate in cognitive intervention after ending this study.
Intervention Type
Other
Intervention Name(s)
group cognitive intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Home-based cognitive intervention
Intervention Description
The participants will do their paper and pencil homework for 30 minutes every business days for 12 weeks.
Primary Outcome Measure Information:
Title
Modified Alzheimer's Disease Assessment Scale-Cognitive subscale(ADAS-cog)
Time Frame
postintervention, 12 weeks follow-up, and 24 weeks follow-up
Secondary Outcome Measure Information:
Title
story recall test
Time Frame
postintervention, 12 weeks follow-up, and 24 weeks follow-up
Title
Digit span forward and backward
Time Frame
postintervention, 12 weeks follow-up, and 24 weeks follow-up
Title
Word fluency test
Time Frame
postintervention, 12 weeks follow-up, and 24 weeks follow-up
Title
color-word stroop test
Time Frame
postintervention, 12 weeks follow-up, and 24 weeks follow-up
Title
Digit symbol test
Time Frame
postintervention, 12 weeks follow-up, and 24 weeks follow-up
Title
prospective memory test
Time Frame
postintervention, 12 weeks follow-up, and 24 weeks follow-up
Title
Mini-Mental State Examination
Time Frame
postintervention, 12 weeks follow-up, and 24 weeks follow-up
Title
CDR-SB
Time Frame
postintervention, 12 weeks follow-up, and 24 weeks follow-up
Title
K-AD8
Time Frame
postintervention, 12 weeks follow-up, and 24 weeks follow-up
Title
PRMQ
Time Frame
postintervention, 12 weeks follow-up, and 24 weeks follow-up
Title
MMQ-Strategy
Time Frame
postintervention, 12 weeks follow-up, and 24 weeks follow-up
Title
QOL-AD
Time Frame
postintervention, 12 weeks follow-up, and 24 weeks follow-up
Title
Geriatric Depression Scale-short form
Time Frame
postintervention, 12 weeks follow-up, and 24 weeks follow-up
Title
Bayer ADL
Time Frame
postintervention, 12 weeks follow-up, and 24 weeks follow-up
Title
CGA-NPI
Time Frame
postintervention, 12 weeks follow-up, and 24 weeks follow-up
Title
Subjective cognitive assessment
Time Frame
postintervention, 12 weeks follow-up, and 24 weeks follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
50 to 85 years of age
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 patient who were involved in other clinical trials or treated with experimental drug within 4 weeks
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seong H Choi, MD, PhD
Organizational Affiliation
Inha University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea University Medical College
City
Ansan
Country
Korea, Republic of
Facility Name
Soonchunhyang University Hospital
City
Bucheon
ZIP/Postal Code
420-767
Country
Korea, Republic of
Facility Name
Bucheon St. Mary's Hospital, the Catholic University of Korea
City
Bucheon
Country
Korea, Republic of
Facility Name
Donga University Hospital
City
Busan
ZIP/Postal Code
602-715
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Daejun Eulji University Hopistal
City
Daejun
ZIP/Postal Code
302-799
Country
Korea, Republic of
Facility Name
Myongji Hospital
City
Goyang
ZIP/Postal Code
412-270
Country
Korea, Republic of
Facility Name
NHIC Ilsan Hospital
City
Goyang
Country
Korea, Republic of
Facility Name
Inha Univeristy Hospital
City
Incheon
ZIP/Postal Code
400-711
Country
Korea, Republic of
Facility Name
Jeju National University Hospital
City
Jeju
Country
Korea, Republic of
Facility Name
Maryknoll Hospital
City
Pusan
Country
Korea, Republic of
Facility Name
Bobath Memorial Hospital
City
Seongnam
Country
Korea, Republic of
Facility Name
Sungkyunkwan University, Samsung Seoul Hospital
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Asan Medical Center, Psychiatry
City
Seoul
ZIP/Postal Code
431-060
Country
Korea, Republic of
Facility Name
Inje University Sanggye Paik Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Konkuk University Medical Cener
City
Seoul
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Suwon
Country
Korea, Republic of
Facility Name
Hyoja Geriatric Hospital
City
Yongin
Country
Korea, Republic of
12. IPD Sharing Statement
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Efficacy Study of Cognitive Intervention in Amnestic Mild Cognitive Impairment
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