NCT03405857

Brief Summary

The purpose of this study is to investigate the effect of cognitive rehabilitation program on the improvement of cognitive functions in patients with mild cognitive impairment(MCI).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

May 25, 2016

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 1, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 7, 2018

Completed
Last Updated

August 2, 2018

Status Verified

December 1, 2017

Enrollment Period

1.7 years

First QC Date

January 1, 2018

Last Update Submit

July 31, 2018

Conditions

Mild Cognitive Impairment

Keywords

mild cognitive impairmentcognitive training program

Outcome Measures

Primary Outcomes (8)

  • Change from baseline performance on Digit Span Test (Neuropsychological test) at 4 weeks and 8 weeks

    It measures auditory attention span and includes forward and backward trials. The participant listens to a series of numbers and calls the sequence correctly. The sequence increases in each trial. The final score is the longest number of sequential digits that the participant can remember correctly. The scores range from 3 to 8. The higher the score, the better the performance.

    baseline, 4 weeks and 8 weeks

  • Change from baseline performance on Visual Span Test (Neuropsychological test) at 4 weeks and 8 weeks

    It measures spatial attention span and includes forward and backward trials. The participant will see sequence of blocks "lit up" on a computer screen, and then repeat the sequence in order or back in order. The sequence increases in each trial. The final score is the longest number of sequential blocks that the participant can remember correctly. The scores range from 3 to 8. The higher the score, the better the performance.

    baseline, 4 weeks and 8 weeks

  • Change from baseline performance on Visual Continuous Performance Test (Neuropsychological test) at 4 weeks and 8 weeks

    It measures a participant's visual sustained and selective attention. The participant will see numbers from "0" to "9" presented on a computer screen and they must click the mouse when "3" appeared. The test will run for 9 minutes. The main scores produced in this test are omission errors, commission errors and reaction times. Higher score means worse performance.

    baseline, 4 weeks and 8 weeks

  • Change from baseline performance on Auditory Continuous Performance Test (Neuropsychological test) at 4 weeks and 8 weeks

    It measures a participant's auditory sustained and selective attention. The participant will hear numbers from "0" to "9", and when they hear "3" they must click the mouse. The test will run for 9 minutes. The main scores produced in this test are omission errors, commission errors and reaction times. Higher score means worse performance.

    baseline, 4 weeks and 8 weeks

  • Change from baseline performance on Trail Making Test (Neuropsychological test) at 4 weeks and 8 weeks

    It consists of type A and type B trials. The participant should connect the numbers (1\~25) as quickly as possible in type A trial, and connect the numbers (1\~13) and alphabets (A\~L) alternatively as quickly as possible in type B trial. The main scores produced in this test are completion time and errors. Higher score means worse performance.

    baseline, 4 weeks and 8 weeks

  • Change from baseline performance on Stroop test (Neuropsychological test) at 4 weeks and 8 weeks

    It measures a participant's processing speed, selective attention and inhibitory control. The participant will be asked to read 'word' of the colored words or 'name of the color' of the colored words in separate trials. The main scores produced in this test are completion time and errors. The contrast score of the two trial's completion time means interference.

    baseline, 4 weeks and 8 weeks

  • Change from baseline performance on Visual Recognition test (Neuropsychological test) at 4 weeks and 8 weeks

    It measures participant's visual memory. The participant will see 15 visual patterns presented on a computer screen and recognize them immediately. The participant will be asked to recognize the 15 patterns after 20 minutes again. The main scores produced in this test are the numbers of recognized patterns in immediate and delayed trials. Immediate memory score is the sum of 5 trial's correct response and score ranges between 0 and 60. Delayed memory score is the correct response of the delayed trial and the score range is 0 to 15. Higher score means better performance.

    baseline, 4 weeks and 8 weeks

  • Change from baseline performance on Auditory Verbal Learning test (Neuropsychological test) at 4 weeks and 8 weeks

    It measures participant's verbal memory. The participant will hear 15 words and recall them immediately and after 20 minutes again. The main scores produced in this test are the numbers of recalled words of the immediate and delayed trials. Immediate memory score is the sum of 5 trial's correct response and score ranges between 0 and 60. Delayed memory score is the correct response of the delayed trial and the score range is 0 to 15. Higher score means better performance.

    baseline, 4 weeks and 8 weeks

Secondary Outcomes (2)

  • Change from baseline score on Korean Version of Geriatric Depression Test Short Form (Depression scale) at 4 weeks and 8 weeks

    baseline, 4 weeks and 8 weeks

  • Change from baseline activity on functional Near-Infrared Spectroscopy (fNIRS) at 4 weeks and 8 weeks

    baseline, 4 weeks and 8 weeks

Study Arms (2)

Group 1

EXPERIMENTAL

Cognitive rehabilitation program will be administered for 4 weeks, three times a week, 30 minutes a day

Other: Cognitive rehabilitation program

Group 2

NO INTERVENTION

No intervention will be administered

Interventions

Cognitive rehabilitation programOTHER

Cognitive rehabilitation programs have been developed to improve the cognitive functions of the elderly or patients with cognitive impairments. The program includes sub-categories such as attention, working memory, memory and executive functions with various levels of difficulty.

Also known as: Computer-aided Cognitive Rehabilitation Training System
Group 1

Eligibility Criteria

Age55 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are diagnosed with mild cognitive impairment through clinical interview, neuropsychological tests and brain imaging
  • No history of neurologic diseases

You may not qualify if:

  • Severe cognitive problems(MMSE\<10)
  • Other psychiatric disorder including bipolar or schizophrenic disorder
  • Other problems disturbing cognitive tests

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Yun-Hee Kim, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 1, 2018

First Posted

January 23, 2018

Study Start

May 25, 2016

Primary Completion

January 25, 2018

Study Completion

April 7, 2018

Last Updated

August 2, 2018

Record last verified: 2017-12

Locations

KR(1)