Mild Cognitive ImpairmentCogMCINCT01358955
Efficacy Study of Cognitive Intervention in Amnestic Mild Cognitive Impairment
A study testing group cognitive intervention and Home-based cognitive intervention in people with Mild Cognitive Impairment, run by Inha University Hospital at 18 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- group cognitive intervention and Home-based cognitive intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 293 participants
- Where
- 18 sitesSouth Korea
- Study dates
- Mar 2011to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
South Korea18 sites
Korea University Medical College
Ansan
Soonchunhyang University Hospital
Bucheon-si, 420-767
Bucheon St. Mary's Hospital, the Catholic University of Korea
Bucheon-si
Donga University Hospital
Busan, 602-715
Pusan National University Hospital
Busan
Daejun Eulji University Hopistal
Daejun, 302-799
Myongji Hospital
Goyang, 412-270
NHIC Ilsan Hospital
Goyang
Inha Univeristy Hospital
Incheon, 400-711
Jeju National University Hospital
Jeju City
Maryknoll Hospital
Pusan
Bobath Memorial Hospital
Seongnam
Sungkyunkwan University, Samsung Seoul Hospital
Seoul, 135-710
Asan Medical Center, Psychiatry
Seoul, 431-060
Inje University Sanggye Paik Hospital
Seoul
Konkuk University Medical Cener
Seoul
Ajou University Hospital
Suwon
Hyoja Geriatric Hospital
Yŏngin
About this study
Official title: A Multicenter, Randomized Trial to Assess Efficacy of Home-based and Group Cognitive Intervention Programs in Amnestic Mild Cognitive Impairment
- 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.
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- group cognitive intervention, Home-based cognitive intervention
- Keywords
- mild cognitive impairment, cognitive therapy, prevention
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
group cognitive interventionOther
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 interventionOther
The participants will do their paper and pencil homework for 30 minutes every business days for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group cognitive intervention | Active comparator | 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. Receives: Other: group cognitive intervention |
| Home-based cognitive intervention | Active comparator | The participants will do their homework for 30 minutes every business days for 12 weeks. Receives: Other: Home-based cognitive intervention |
| Wait list Control | No intervention | They will participate in cognitive intervention after ending this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Alzheimer's Disease Assessment Scale-Cognitive subscale(ADAS-cog)
Measured: postintervention, 12 weeks follow-up, and 24 weeks follow-up
Secondary outcomes (16)
story recall test
Measured: postintervention, 12 weeks follow-up, and 24 weeks follow-up
Digit span forward and backward
Measured: postintervention, 12 weeks follow-up, and 24 weeks follow-up
Word fluency test
Measured: postintervention, 12 weeks follow-up, and 24 weeks follow-up
color-word stroop test
Measured: postintervention, 12 weeks follow-up, and 24 weeks follow-up
Digit symbol test
Measured: postintervention, 12 weeks follow-up, and 24 weeks follow-up
prospective memory test
Measured: postintervention, 12 weeks follow-up, and 24 weeks follow-up
Mini-Mental State Examination
Measured: postintervention, 12 weeks follow-up, and 24 weeks follow-up
CDR-SB
Measured: postintervention, 12 weeks follow-up, and 24 weeks follow-up
K-AD8
Measured: postintervention, 12 weeks follow-up, and 24 weeks follow-up
PRMQ
Measured: postintervention, 12 weeks follow-up, and 24 weeks follow-up
MMQ-Strategy
Measured: postintervention, 12 weeks follow-up, and 24 weeks follow-up
QOL-AD
Measured: postintervention, 12 weeks follow-up, and 24 weeks follow-up
Geriatric Depression Scale-short form
Measured: postintervention, 12 weeks follow-up, and 24 weeks follow-up
Bayer ADL
Measured: postintervention, 12 weeks follow-up, and 24 weeks follow-up
CGA-NPI
Measured: postintervention, 12 weeks follow-up, and 24 weeks follow-up
Subjective cognitive assessment
Measured: postintervention, 12 weeks follow-up, and 24 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2011 (estimated)
- Study startMar 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 293 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inha University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Eisai Inc.
- Responsible party
- Principal investigator, Chul Soo Kim, Inha University Hospital
- Investigators
- Seong H Choi, MD, PhD, Principal investigator, Inha University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01358955
- Sponsor's protocol ID
- CogMCI study
- Acronym
- CogMCI
- Status last verified
- Aug 2013
- First submitted
- 20 May 2011
- Last updated
- 28 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized Trial to Assess Efficacy of Home-based and Group Cognitive Intervention Programs in Amnestic Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT01358955
- Acronym / sponsor ID
- CogMCI / CogMCI study
- Conditions
- Mild Cognitive Impairment
- Keywords
- mild cognitive impairment, cognitive therapy, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 293 participants (actual)
- Lead sponsor
- Inha University HospitalUniversity, hospital or other
- Collaborators
- Eisai Inc.
- Study start
- Mar 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 24 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group cognitive intervention | Active comparator | Other: group cognitive interventionThe 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 | Active comparator | Other: Home-based cognitive interventionThe participants will do their homework for 30 minutes every business days for 12 weeks. |
| Wait list Control | No intervention | –They will participate in cognitive intervention after ending this study. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| group cognitive interventionThe 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. | Other | Group cognitive intervention |
| Home-based cognitive interventionThe participants will do their paper and pencil homework for 30 minutes every business days for 12 weeks. | Other | Home-based cognitive intervention |
Primary outcome
Modified Alzheimer's Disease Assessment Scale-Cognitive subscale(ADAS-cog)
Time frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up
16 secondary outcomes
story recall test
Time frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up
Digit span forward and backward
Time frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up
Word fluency test
Time frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up
color-word stroop test
Time frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up
Digit symbol test
Time frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up
prospective memory test
Time frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up
Mini-Mental State Examination
Time frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up
CDR-SB
Time frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up
K-AD8
Time frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up
PRMQ
Time frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up
MMQ-Strategy
Time frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up
QOL-AD
Time frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up
Geriatric Depression Scale-short form
Time frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up
Bayer ADL
Time frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up
CGA-NPI
Time frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up
Subjective cognitive assessment
Time frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seong H Choi, MD, PhD principal investigator
Inha University Hospital
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing group cognitive intervention and Home-based cognitive intervention in people with Mild Cognitive Impairment, run by Inha University Hospital at 18 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Alzheimer's Disease Assessment Scale-Cognitive subscale(ADAS-cog) (time frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2013.