Efficacy Study of Cognitive Intervention in Amnestic Mild Cognitive Impairment

Mild Cognitive Impairment Clinical Trial

— CogMCI  

Official title:

A Multicenter, Randomized Trial to Assess Efficacy of Home-based and Group Cognitive Intervention Programs in Amnestic Mild Cognitive Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01358955
• Other study ID #: CogMCI study
• Status: Completed
• Phase: N/A
• First received: May 20, 2011
• Last updated: August 27, 2013
• Start date: March 2011
• Est. completion date: January 2013

Study information

• Verified date: August 2013
• Source: Inha University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 293
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Mild Cognitive Impairment

Intervention

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.
• Home-based cognitive intervention
The participants will do their paper and pencil homework for 30 minutes every business days for 12 weeks.

Locations

Country	Name	City	State
Korea, Republic of	Korea University Medical College	Ansan
Korea, Republic of	Bucheon St. Mary's Hospital, the Catholic University of Korea	Bucheon
Korea, Republic of	Soonchunhyang University Hospital	Bucheon
Korea, Republic of	Donga University Hospital	Busan
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	Daejun Eulji University Hopistal	Daejun
Korea, Republic of	Myongji Hospital	Goyang
Korea, Republic of	NHIC Ilsan Hospital	Goyang
Korea, Republic of	Inha Univeristy Hospital	Incheon
Korea, Republic of	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	Inje University Sanggye Paik Hospital	Seoul
Korea, Republic of	Konkuk University Medical Cener	Seoul
Korea, Republic of	Sungkyunkwan University, Samsung Seoul Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon
Korea, Republic of	Hyoja Geriatric Hospital	Yongin

Sponsors (2)

Lead Sponsor	Collaborator
Inha University Hospital	Eisai Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Alzheimer's Disease Assessment Scale-Cognitive subscale(ADAS-cog)		postintervention, 12 weeks follow-up, and 24 weeks follow-up	No
Secondary	story recall test		postintervention, 12 weeks follow-up, and 24 weeks follow-up	No
Secondary	Digit span forward and backward		postintervention, 12 weeks follow-up, and 24 weeks follow-up	No
Secondary	Word fluency test		postintervention, 12 weeks follow-up, and 24 weeks follow-up	No
Secondary	color-word stroop test		postintervention, 12 weeks follow-up, and 24 weeks follow-up	No
Secondary	Digit symbol test		postintervention, 12 weeks follow-up, and 24 weeks follow-up	No
Secondary	prospective memory test		postintervention, 12 weeks follow-up, and 24 weeks follow-up	No
Secondary	Mini-Mental State Examination		postintervention, 12 weeks follow-up, and 24 weeks follow-up	No
Secondary	CDR-SB		postintervention, 12 weeks follow-up, and 24 weeks follow-up	No
Secondary	K-AD8		postintervention, 12 weeks follow-up, and 24 weeks follow-up	No
Secondary	PRMQ		postintervention, 12 weeks follow-up, and 24 weeks follow-up	No
Secondary	MMQ-Strategy		postintervention, 12 weeks follow-up, and 24 weeks follow-up	No
Secondary	QOL-AD		postintervention, 12 weeks follow-up, and 24 weeks follow-up	No
Secondary	Geriatric Depression Scale-short form		postintervention, 12 weeks follow-up, and 24 weeks follow-up	No
Secondary	Bayer ADL		postintervention, 12 weeks follow-up, and 24 weeks follow-up	No
Secondary	CGA-NPI		postintervention, 12 weeks follow-up, and 24 weeks follow-up	No
Secondary	Subjective cognitive assessment		postintervention, 12 weeks follow-up, and 24 weeks follow-up	No