Clinical trial NCT01358955: Efficacy Study of Cognitive Intervention in Amnestic Mild Cognitive Impairment
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
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: mild cognitive impairment
cognitive therapy
prevention
Lead sponsor: Inha University Hospital
Sponsor class: OTHER
Collaborators: name: Eisai Inc.
First posted: 2011-05-24
Enrollment: 293
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Modified Alzheimer's Disease Assessment Scale-Cognitive subscale(ADAS-cog)
timeFrame: postintervention, 12 weeks follow-up, and 24 weeks follow-up
Secondary outcomes:
measure: story recall test
timeFrame: postintervention, 12 weeks follow-up, and 24 weeks follow-up
measure: Digit span forward and backward
timeFrame: postintervention, 12 weeks follow-up, and 24 weeks follow-up
measure: Word fluency test
timeFrame: postintervention, 12 weeks follow-up, and 24 weeks follow-up
measure: color-word stroop test
timeFrame: postintervention, 12 weeks follow-up, and 24 weeks follow-up
measure: Digit symbol test
timeFrame: postintervention, 12 weeks follow-up, and 24 weeks follow-up
measure: prospective memory test
timeFrame: postintervention, 12 weeks follow-up, and 24 weeks follow-up
measure: Mini-Mental State Examination
timeFrame: postintervention, 12 weeks follow-up, and 24 weeks follow-up
measure: CDR-SB
timeFrame: postintervention, 12 weeks follow-up, and 24 weeks follow-up
measure: K-AD8
timeFrame: postintervention, 12 weeks follow-up, and 24 weeks follow-up
measure: PRMQ
timeFrame: postintervention, 12 weeks follow-up, and 24 weeks follow-up
measure: MMQ-Strategy
timeFrame: postintervention, 12 weeks follow-up, and 24 weeks follow-up
measure: QOL-AD
timeFrame: postintervention, 12 weeks follow-up, and 24 weeks follow-up
measure: Geriatric Depression Scale-short form
timeFrame: postintervention, 12 weeks follow-up, and 24 weeks follow-up
measure: Bayer ADL
timeFrame: postintervention, 12 weeks follow-up, and 24 weeks follow-up
measure: CGA-NPI
timeFrame: postintervention, 12 weeks follow-up, and 24 weeks follow-up
measure: Subjective cognitive assessment
timeFrame: postintervention, 12 weeks follow-up, and 24 weeks follow-up
Other outcomes:
Locations:
city: Ansan
country: Korea, Republic of
facility: Korea University Medical College
city: Bucheon
country: Korea, Republic of
facility: Soonchunhyang University Hospital
city: Bucheon
country: Korea, Republic of
facility: Bucheon St. Mary's Hospital, the Catholic University of Korea
city: Busan
country: Korea, Republic of
facility: Donga University Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daejun
country: Korea, Republic of
facility: Daejun Eulji University Hopistal
city: Goyang
country: Korea, Republic of
facility: Myongji Hospital
city: Goyang
country: Korea, Republic of
facility: NHIC Ilsan Hospital
city: Incheon
country: Korea, Republic of
facility: Inha Univeristy Hospital
city: Jeju
country: Korea, Republic of
facility: Jeju National University Hospital
city: Pusan
country: Korea, Republic of
facility: Maryknoll Hospital
city: Seongnam
country: Korea, Republic of
facility: Bobath Memorial Hospital
city: Seoul
country: Korea, Republic of
facility: Sungkyunkwan University, Samsung Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center, Psychiatry
city: Seoul
country: Korea, Republic of
facility: Inje University Sanggye Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Cener
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Yongin
country: Korea, Republic of
facility: Hyoja Geriatric Hospital
Study officials:
affiliation: Inha University Hospital
name: Seong H Choi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: