NCT01358955

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
293

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2011

Typical duration for not_applicable

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 24, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

August 28, 2013

Status Verified

August 1, 2013

Enrollment Period

1.8 years

First QC Date

May 20, 2011

Last Update Submit

August 27, 2013

Conditions

Mild Cognitive Impairment

Keywords

mild cognitive impairmentcognitive therapyprevention

Outcome Measures

Primary Outcomes (1)

  • Modified Alzheimer's Disease Assessment Scale-Cognitive subscale(ADAS-cog)

    postintervention, 12 weeks follow-up, and 24 weeks follow-up

Secondary Outcomes (16)

  • 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

  • +11 more secondary outcomes

Study Arms (3)

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.

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.

Other: Home-based cognitive intervention

Wait list Control

NO INTERVENTION

They will participate in cognitive intervention after ending this study.

Interventions

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.

Group cognitive intervention
Home-based cognitive interventionOTHER

The participants will do their paper and pencil homework for 30 minutes every business days for 12 weeks.

Home-based cognitive intervention

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Korea University Medical College

Ansan, South Korea

Location

Soonchunhyang University Hospital

Bucheon-si, 420-767, South Korea

Location

Bucheon St. Mary's Hospital, the Catholic University of Korea

Bucheon-si, South Korea

Location

Donga University Hospital

Busan, 602-715, South Korea

Location

Pusan National University Hospital

Busan, South Korea

Location

Daejun Eulji University Hopistal

Daejun, 302-799, South Korea

Location

Myongji Hospital

Goyang, 412-270, South Korea

Location

NHIC Ilsan Hospital

Goyang, South Korea

Location

Inha Univeristy Hospital

Incheon, 400-711, South Korea

Location

Jeju National University Hospital

Jeju City, South Korea

Location

Maryknoll Hospital

Pusan, South Korea

Location

Bobath Memorial Hospital

Seongnam, South Korea

Location

Sungkyunkwan University, Samsung Seoul Hospital

Seoul, 135-710, South Korea

Location

Asan Medical Center, Psychiatry

Seoul, 431-060, South Korea

Location

Inje University Sanggye Paik Hospital

Seoul, South Korea

Location

Konkuk University Medical Cener

Seoul, South Korea

Location

Ajou University Hospital

Suwon, South Korea

Location

Hyoja Geriatric Hospital

Yŏngin, South Korea

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Seong H Choi, MD, PhD

    Inha University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 20, 2011

First Posted

May 24, 2011

Study Start

March 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

August 28, 2013

Record last verified: 2013-08

Locations

KR(18)