Efficacy of Cognitive Training in Subjective Memory Impairment

A Prospective, Three-arm, Parallel Design, Controlled Trial to Assess Efficacy of Cognitive Training in Subjective Memory Impairment

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.

Study Overview

• Status: Completed
• Conditions: Memory Loss
• Intervention / Treatment: Behavioral: cognitive training; Behavioral: lifestyle modification

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Jae-Hong Lee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.; 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
Active Comparator: 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.	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
No Intervention: No intervention; This group receives no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
cognitive failure questionnaire	questionnaire for measuring self reported cognitive status. score range: 0-100. Higher score means worse cognitive status.	3 month
Mini-mental state examination	mini-mental state examination that examines general cognition. range 0-20. Higher score means better cognition.	3 month
Geriatric depression scale	questionnaire for depression measuring. score range:0-15. lower score means less depression.	3 month
Beck anxiety index	questionnaire for self reporting anxiety measuring. range:0-63. low score means less anxiety.	3 month
Seoul instrumental activities of daily living	scale for measuring activities of daily living limitation. score range 0-45. low score means better ability.	3 month
Rey complex figure copy test	test for visuospatial function. Participants should copy the complex figure. score range: 0-36. Higher score means better visuospatial function.	3 month
Digit symbol test	a test for attention and psychomotor speed. Participants are instructed to write an appropriately matched code for each number. Correct number is counted. score range: 0-76. Higher score means better function.	3 month
Seoul verbal learning test, immediate recall	measuring tool for immediate memory function. Investigators read 12 words to participants. Participants should remember the words. Tests are done 3 times. score range: 0-36. Higher score means better immediate memory function	3 month
Seoul verbal learning test, delayed recall	measuring tool for 20 minutes delayed memory function. After 20 minutes from the immediate recall test, participants should remember the words. score range: 0-12. Higher score means better delayed memory function	3 month
Seoul verbal learning test, delayed recall	measuring tool for cued recall of verbal memory function. score range: 0-24. 2. Higher score means better memory recognition function	3 month
Logical memory test, delayed recall	logical memory test is a part of a neuropsychological test named Wechsler	3 month

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Investigators: Principal Investigator: Jae-Hong Lee, MD,PhD, Asan Medical Center

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: September 18, 2015
• First Submitted That Met QC Criteria: September 21, 2015
• First Posted (Estimate): September 22, 2015

Study Record Updates

• Last Update Posted (Actual): August 7, 2018
• Last Update Submitted That Met QC Criteria: August 6, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: cognitive training; subjective memory impairment
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Memory Disorders
• Other Study ID Numbers: YJeongHong