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

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.

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Other: group cognitive intervention; Other: Home-based cognitive intervention

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 Type: Interventional
• Enrollment (Actual): 293
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Ansan, Korea, Republic of
    • Korea University Medical College
  • Bucheon, Korea, Republic of, 420-767
    • Soonchunhyang University Hospital
  • Bucheon, Korea, Republic of
    • Bucheon St. Mary's Hospital, The Catholic University of Korea
  • Busan, Korea, Republic of
    • Pusan National University Hospital
  • Busan, Korea, Republic of, 602-715
    • DongA University Hospital
  • Daejun, Korea, Republic of, 302-799
    • Daejun Eulji University Hopistal
  • Goyang, Korea, Republic of
    • NHIC Ilsan Hospital
  • Goyang, Korea, Republic of, 412-270
    • Myongji Hospital
  • Incheon, Korea, Republic of, 400-711
    • Inha Univeristy Hospital
  • Jeju, Korea, Republic of
    • Jeju National University Hospital
  • Pusan, Korea, Republic of
    • Maryknoll Hospital
  • Seongnam, Korea, Republic of
    • Bobath Memorial Hospital
  • Seoul, Korea, Republic of
    • Inje University Sanggye Paik Hospital
  • Seoul, Korea, Republic of, 135-710
    • Sungkyunkwan University, Samsung Seoul Hospital
  • Seoul, Korea, Republic of, 431-060
    • Asan Medical Center, Psychiatry
  • Seoul, Korea, Republic of
    • Konkuk University Medical Cener
  • Suwon, Korea, Republic of
    • Ajou University Hospital
  • Yongin, Korea, Republic of
    • Hyoja Geriatric Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Modified Alzheimer's Disease Assessment Scale-Cognitive subscale(ADAS-cog)	postintervention, 12 weeks follow-up, and 24 weeks follow-up

Secondary Outcome Measures

Outcome Measure	Time Frame
story recall test	postintervention, 12 weeks follow-up, and 24 weeks follow-up
Digit span forward and backward	postintervention, 12 weeks follow-up, and 24 weeks follow-up
Word fluency test	postintervention, 12 weeks follow-up, and 24 weeks follow-up
color-word stroop test	postintervention, 12 weeks follow-up, and 24 weeks follow-up
Digit symbol test	postintervention, 12 weeks follow-up, and 24 weeks follow-up
prospective memory test	postintervention, 12 weeks follow-up, and 24 weeks follow-up
Mini-Mental State Examination	postintervention, 12 weeks follow-up, and 24 weeks follow-up
CDR-SB	postintervention, 12 weeks follow-up, and 24 weeks follow-up
K-AD8	postintervention, 12 weeks follow-up, and 24 weeks follow-up
PRMQ	postintervention, 12 weeks follow-up, and 24 weeks follow-up
MMQ-Strategy	postintervention, 12 weeks follow-up, and 24 weeks follow-up
QOL-AD	postintervention, 12 weeks follow-up, and 24 weeks follow-up
Geriatric Depression Scale-short form	postintervention, 12 weeks follow-up, and 24 weeks follow-up
Bayer ADL	postintervention, 12 weeks follow-up, and 24 weeks follow-up
CGA-NPI	postintervention, 12 weeks follow-up, and 24 weeks follow-up
Subjective cognitive assessment	postintervention, 12 weeks follow-up, and 24 weeks follow-up

Collaborators and Investigators

• Sponsor: Inha University Hospital
• Collaborators: Eisai Inc.
• Investigators: Principal Investigator: Seong H Choi, MD, PhD, Inha University Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: May 20, 2011
• First Submitted That Met QC Criteria: May 20, 2011
• First Posted (Estimate): May 24, 2011

Study Record Updates

• Last Update Posted (Estimate): August 28, 2013
• Last Update Submitted That Met QC Criteria: August 27, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: prevention; mild cognitive impairment; cognitive therapy
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: CogMCI study