Efficacy of Cognitive Training in Subjective Memory Impairment

NCT ID: NCT02555774

Last Updated: 2018-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-02-29

Brief Summary

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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.

Detailed Description

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Subjective memory impairment is currently thought to be a risky state of progression to Alzheimer's disease. This study aims to confirm whether cognitive training in subjective memory impairment would show improvement in the subjective and objective cognition. We include subjects with normal cognition but complained subjective feeling of memory decline and conduct cognitive training programs combined with lifestyle modifications for 3 months. We evaluate the neuropsychological tests and questionnaires about subjective improvement after 3 months of interventions.

Conditions

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Memory Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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cognitive training

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.

Group Type EXPERIMENTAL

cognitive training

Intervention Type BEHAVIORAL

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.

lifestyle modification

Intervention Type BEHAVIORAL

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

lifestyle modification

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.

Group Type ACTIVE_COMPARATOR

lifestyle modification

Intervention Type BEHAVIORAL

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

No intervention

This group receives no intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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cognitive training

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.

Intervention Type BEHAVIORAL

lifestyle modification

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

55 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jae-Hong Lee

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jae-Hong Lee, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Jae-Hong Lee

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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YJeongHong

Identifier Type: -

Identifier Source: org_study_id

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