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Completed

NCT Number: NCT02555774

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.

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Key information

Conditions

Memory Loss Memory Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

55 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jae-Hong Lee

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive training

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

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

Primary outcomes

  1. Paired associates learning test

    Time frame: 3 month

    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.

  2. Rapid visual information processing test

    Time frame: 3 month

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

  3. Pattern recognition memory test

    Time frame: 3 month

    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.%

  4. Spatial working memory test

    Time frame: 3 month

    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.

Secondary outcomes

  1. cognitive failure questionnaire

    Time frame: 3 month

    questionnaire for measuring self reported cognitive status. score range: 0-100. Higher score means worse cognitive status.

  2. Mini-mental state examination

    Time frame: 3 month

    mini-mental state examination that examines general cognition. range 0-20. Higher score means better cognition.

  3. Geriatric depression scale

    Time frame: 3 month

    questionnaire for depression measuring. score range:0-15. lower score means less depression.

  4. Beck anxiety index

    Time frame: 3 month

    questionnaire for self reporting anxiety measuring. range:0-63. low score means less anxiety.

  5. Seoul instrumental activities of daily living

    Time frame: 3 month

    scale for measuring activities of daily living limitation. score range 0-45. low score means better ability.

  6. Rey complex figure copy test

    Time frame: 3 month

    test for visuospatial function. Participants should copy the complex figure. score range: 0-36. Higher score means better visuospatial function.

  7. Digit symbol test

    Time frame: 3 month

    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.

  8. Seoul verbal learning test, immediate recall

    Time frame: 3 month

    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

  9. Seoul verbal learning test, delayed recall

    Time frame: 3 month

    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

  10. Seoul verbal learning test, delayed recall

    Time frame: 3 month

    measuring tool for cued recall of verbal memory function. score range: 0-24. 2. Higher score means better memory recognition function

  11. Logical memory test, delayed recall

    Time frame: 3 month

    logical memory test is a part of a neuropsychological test named Wechsler

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Sep 22, 2015
Registry last updated
Aug 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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