NCT02480738

Brief Summary

This study is to investigate the effectiveness of computerized cognitive training, and corresponding neural substrates through multimodal neuroimaging assessment, in the elderly with normal cognition, subjective cognitive impairment, and mild cognitive impairment.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2012

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

June 1, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 22, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 24, 2015

Completed
Last Updated

May 20, 2019

Status Verified

May 1, 2019

Enrollment Period

10 months

First QC Date

June 22, 2015

Last Update Submit

May 16, 2019

Conditions

Mild Cognitive Impairment

Keywords

subjective cognitive impairment

Outcome Measures

Primary Outcomes (1)

  • Clinical improvement in the follow-up neuropsychological tests

    changes in memory and frontal domain subscores between the baseline and follow-up

    12 weeks

Secondary Outcomes (4)

  • Cortical thickness changes between baseline and follow-up volumetric MRI

    12 weeks

  • White matter integrities changes between baseline and follow-up diffusion tensor imaging

    12 weeks

  • Spectral ratio changes between baseline and follow-up EEG

    12 weeks

  • local activation pattern changes between baseline and follow-up Fludeoxyglucose PET

    12 weeks

Study Arms (3)

Mild cognitive impairment

EXPERIMENTAL

Intervention: Computerized Cognitive Training Apparatus

Behavioral: Computerized Cognitive Training Apparatus

Subjective cognitive impairment

EXPERIMENTAL

Intervention: Computerized Cognitive Training Apparatus

Behavioral: Computerized Cognitive Training Apparatus

Normal controls

ACTIVE COMPARATOR

Intervention: Computerized Cognitive Training Apparatus

Behavioral: Computerized Cognitive Training Apparatus

Interventions

Computerized Cognitive Training ApparatusBEHAVIORAL

CoCoTA was developed through collaborative research with the Korean Institute of Science and Technology (KIST) and Primpo Co. Ltd. (www.primpo.com). It was designed to stimulate numerous cognitive domains simultaneously by using sounds and objects familiar to Korean elderly. Training themes and scenarios were developed and evaluated by six board-certified neurologists and three neuropsychologists who specialize in dementia. Each subject participated in a total of 24 sessions of cognitive training, which consisted of 40 minutes of training, twice per week. To assure the consistency of cognitive training, trained personnel stayed nearby the subjects to help throughout the training process.

Also known as: CoCoTA
Mild cognitive impairmentNormal controlsSubjective cognitive impairment

Eligibility Criteria

Age51 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages \>50 to ≤70
  • Years of education ≥ 6 years
  • No physical barrier preventing the dominant hand from using the computer mouse

You may not qualify if:

  • Subjects who had any structural lesions or psychiatric disorders that explained the memory deficits
  • Subjects had to be able to undergo pre- and post-training evaluations such as electroencephalography (EEG), FDG-PET, and magnetic resonance imaging (MRI)
  • Subjects who had scalp lesions, severe back pain, or claustrophobia that precluded pre- and post-training evaluations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Na HR, Lim JS, Kim WJ, Jang JW, Baek MJ, Kim J, Park YH, Park SY, Kim S. Multimodal Assessment of Neural Substrates in Computerized Cognitive Training: A Preliminary Study. J Clin Neurol. 2018 Oct;14(4):454-463. doi: 10.3988/jcn.2018.14.4.454. Epub 2018 Jun 26.

    PMID: 30198220RESULT

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • SangYun Kim, MD,PhD

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 22, 2015

First Posted

June 24, 2015

Study Start

June 1, 2012

Primary Completion

April 1, 2013

Study Completion

July 1, 2013

Last Updated

May 20, 2019

Record last verified: 2019-05