Efficacy Study of Cognitive Intervention in Amnestic Mild Cognitive Impairment (CogMCI)

This study has been completed.
Sponsor:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
Chul Soo Kim, Inha University Hospital
ClinicalTrials.gov Identifier:
NCT01358955
First received: May 20, 2011
Last updated: August 27, 2013
Last verified: August 2013
  Purpose
  • 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.

Condition Intervention
Mild Cognitive Impairment
Other: group cognitive intervention
Other: Home-based cognitive intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized Trial to Assess Efficacy of Home-based and Group Cognitive Intervention Programs in Amnestic Mild Cognitive Impairment

Resource links provided by NLM:


Further study details as provided by Inha University Hospital:

Primary Outcome Measures:
  • Modified Alzheimer's Disease Assessment Scale-Cognitive subscale(ADAS-cog) [ Time Frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • story recall test [ Time Frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up ] [ Designated as safety issue: No ]
  • Digit span forward and backward [ Time Frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up ] [ Designated as safety issue: No ]
  • Word fluency test [ Time Frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up ] [ Designated as safety issue: No ]
  • color-word stroop test [ Time Frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up ] [ Designated as safety issue: No ]
  • Digit symbol test [ Time Frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up ] [ Designated as safety issue: No ]
  • prospective memory test [ Time Frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up ] [ Designated as safety issue: No ]
  • Mini-Mental State Examination [ Time Frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up ] [ Designated as safety issue: No ]
  • CDR-SB [ Time Frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up ] [ Designated as safety issue: No ]
  • K-AD8 [ Time Frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up ] [ Designated as safety issue: No ]
  • PRMQ [ Time Frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up ] [ Designated as safety issue: No ]
  • MMQ-Strategy [ Time Frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up ] [ Designated as safety issue: No ]
  • QOL-AD [ Time Frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up ] [ Designated as safety issue: No ]
  • Geriatric Depression Scale-short form [ Time Frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up ] [ Designated as safety issue: No ]
  • Bayer ADL [ Time Frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up ] [ Designated as safety issue: No ]
  • CGA-NPI [ Time Frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up ] [ Designated as safety issue: No ]
  • Subjective cognitive assessment [ Time Frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up ] [ Designated as safety issue: No ]

Enrollment: 293
Study Start Date: March 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Other: 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.
Active Comparator: Home-based cognitive intervention
The participants will do their homework for 30 minutes every business days for 12 weeks.
Other: Home-based cognitive intervention
The participants will do their paper and pencil homework for 30 minutes every business days for 12 weeks.
No Intervention: Wait list Control
They will participate in cognitive intervention after ending this study.

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.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01358955

Locations
Korea, Republic of
Korea University Medical College
Ansan, Korea, Republic of
Soonchunhyang University Hospital
Bucheon, Korea, Republic of, 420-767
Bucheon St. Mary's Hospital, the Catholic University of Korea
Bucheon, Korea, Republic of
Donga University Hospital
Busan, Korea, Republic of, 602-715
Pusan National University Hospital
Busan, Korea, Republic of
Daejun Eulji University Hopistal
Daejun, Korea, Republic of, 302-799
Myongji Hospital
Goyang, Korea, Republic of, 412-270
NHIC Ilsan Hospital
Goyang, Korea, Republic of
Inha Univeristy Hospital
Incheon, Korea, Republic of, 400-711
Jeju National University Hospital
Jeju, Korea, Republic of
Maryknoll Hospital
Pusan, Korea, Republic of
Bobath Memorial Hospital
Seongnam, Korea, Republic of
Asan Medical Center, Psychiatry
Seoul, Korea, Republic of, 431-060
Inje University Sanggye Paik Hospital
Seoul, Korea, Republic of
Sungkyunkwan University, Samsung Seoul Hospital
Seoul, Korea, Republic of, 135-710
Konkuk University Medical Cener
Seoul, Korea, Republic of
Ajou University Hospital
Suwon, Korea, Republic of
Hyoja Geriatric Hospital
Yongin, Korea, Republic of
Sponsors and Collaborators
Inha University Hospital
Eisai Inc.
Investigators
Principal Investigator: Seong H Choi, MD, PhD Inha University Hospital
  More Information

No publications provided

Responsible Party: Chul Soo Kim, Professor, Inha University Hospital
ClinicalTrials.gov Identifier: NCT01358955     History of Changes
Other Study ID Numbers: CogMCI study
Study First Received: May 20, 2011
Last Updated: August 27, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Inha University Hospital:
mild cognitive impairment
cognitive therapy
prevention

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014