NCT02555774

Brief Summary

This study evaluates the efficacy of cognitive training in subjects with subjective memory impairment. The first group will receive cognitive training and lifestyle modification in combination, the second group will receive only lifestyle modification, and the third group will receive no intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2014

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 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 22, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

August 7, 2018

Status Verified

August 1, 2018

Enrollment Period

1.5 years

First QC Date

September 18, 2015

Last Update Submit

August 6, 2018

Conditions

Memory Loss

Keywords

subjective memory impairmentcognitive training

Outcome Measures

Primary Outcomes (4)

  • Paired associates learning test

    paired associates learning test is a part of computerized neuropsychological tests battery named CANTAB (Cambridge Neuropsychological Test Automated Battery). The scores are shown as total number of errors.

    3 month

  • Rapid visual information processing test

    rapid visual information processing is a part of computerized neuropsychological test battery named CANTAB. The score is shown as correct response rate.%

    3 month

  • Pattern recognition memory test

    paired associates learning test is a part of computerized neuropsychological tests battery named CANTAB (Cambridge Neuropsychological Test Automated Battery). The score is shown as correct response rate.%

    3 month

  • Spatial working memory test

    paired associates learning test is a part of computerized neuropsychological tests battery named CANTAB (Cambridge Neuropsychological Test Automated Battery). The scores are shown as total number of errors.

    3 month

Secondary Outcomes (11)

  • cognitive failure questionnaire

    3 month

  • Mini-mental state examination

    3 month

  • Geriatric depression scale

    3 month

  • Beck anxiety index

    3 month

  • Seoul instrumental activities of daily living

    3 month

  • +6 more secondary outcomes

Study Arms (3)

cognitive training

EXPERIMENTAL

Cognitive training programs 2 times a week for 3 months (totally 24 sessions) for 90 minutes per session. Lifestyle modification is educated first, then weekly phone call for lifestyle modification is done by investigators.

Behavioral: cognitive trainingBehavioral: lifestyle modification

lifestyle modification

ACTIVE COMPARATOR

This group receives only lifestyle modification for 3 months. Lifestyle modification is educated at the first, then weekly phone call for lifestyle modification is done by investigators. The method of lifestyle modification is same with the first arm.

Behavioral: lifestyle modification

No intervention

NO INTERVENTION

This group receives no intervention.

Interventions

cognitive trainingBEHAVIORAL

cognitive training is held 2 times a week for 3 months, 90 minutes per 1 session. It includes cognitive exercise of multiple cognitive domains such as memory, attention, calculation, executive function and visuospatial function.

cognitive training
lifestyle modificationBEHAVIORAL

education about lifestyle modification is done by investigators at the first day of the trial and the investigators conduct weekly phone call to participants to educate the lifestyle modifications

cognitive traininglifestyle modification

Eligibility Criteria

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

You may qualify if:

  • Subjects who showed normal range (above 16percentile of norm) in all domains of detailed neuropsychological tests battery named Seoul Neuropsychological Screening Battery (SNSB)
  • Clinical dementia rating (CDR) score of 0
  • Subjects with at least 3 years of formal education

You may not qualify if:

  • Subjects with mild cognitive impairment or dementia
  • Subjects who was diagnosed as any neurological disorders such as epilepsy, stroke, hemorrhage, hydrocephalus, Parkinson's disease or brain tumor
  • Subjects with uncontrolled severe medical conditions according to investigator's opinion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jae-Hong Lee

Seoul, South Korea

Location

MeSH Terms

Conditions

Memory Disorders

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Jae-Hong Lee, MD,PhD

    Asan Medical Center

    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

September 18, 2015

First Posted

September 22, 2015

Study Start

May 1, 2014

Primary Completion

November 1, 2015

Study Completion

February 1, 2016

Last Updated

August 7, 2018

Record last verified: 2018-08

Locations

KR(1)