Memory LossNCT02555774
Efficacy of Cognitive Training in Subjective Memory Impairment
A study testing cognitive training and lifestyle modification in people with Memory Loss, run by Asan Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Memory Loss
- What is being tested?
- cognitive training and lifestyle modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2014to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Memory Loss
- Being tested
- cognitive training, lifestyle modification
- Keywords
- subjective memory impairment, cognitive training
- Medical subject headings
- Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive trainingBehavioural
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 modificationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: cognitive training; Behavioral: 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. Receives: Behavioral: lifestyle modification |
| No intervention | No intervention | This group receives no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.%
Measured: 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.%
Measured: 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.
Measured: 3 month
Secondary outcomes (11)
cognitive failure questionnaire
questionnaire for measuring self reported cognitive status. score range: 0-100. Higher score means worse cognitive status.
Measured: 3 month
Mini-mental state examination
mini-mental state examination that examines general cognition. range 0-20. Higher score means better cognition.
Measured: 3 month
Geriatric depression scale
questionnaire for depression measuring. score range:0-15. lower score means less depression.
Measured: 3 month
Beck anxiety index
questionnaire for self reporting anxiety measuring. range:0-63. low score means less anxiety.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 3 month
Logical memory test, delayed recall
logical memory test is a part of a neuropsychological test named Wechsler
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2015 (estimated)
- Study startMay 2014
- Primary completionNov 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Memory LossStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae-Hong Lee, Asan Medical Center
- Investigators
- Jae-Hong Lee, MD,PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02555774
- Sponsor's protocol ID
- YJeongHong
- Status last verified
- Aug 2018
- First submitted
- 18 Sep 2015
- Last updated
- 7 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Three-arm, Parallel Design, Controlled Trial to Assess Efficacy of Cognitive Training in Subjective Memory Impairment
- ClinicalTrials.gov ID
- NCT02555774
- Acronym / sponsor ID
- YJeongHong
- Conditions
- Memory Loss
- Keywords
- subjective memory impairment, cognitive training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 22 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cognitive training | Experimental | Behavioral: cognitive training, Behavioral: lifestyle modificationCognitive 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. |
| lifestyle modification | Active comparator | Behavioral: lifestyle modificationThis 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. |
| No intervention | No intervention | –This group receives no intervention. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive trainingcognitive 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. | Behavioural | cognitive training |
| lifestyle modificationeducation 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 | Behavioural | cognitive training, lifestyle modification |
Primary outcome
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.
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.%
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.%
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.
11 secondary outcomes
cognitive failure questionnaire
Time frame: 3 month
Mini-mental state examination
Time frame: 3 month
Geriatric depression scale
Time frame: 3 month
Beck anxiety index
Time frame: 3 month
Seoul instrumental activities of daily living
Time frame: 3 month
Rey complex figure copy test
Time frame: 3 month
Digit symbol test
Time frame: 3 month
Seoul verbal learning test, immediate recall
Time frame: 3 month
Seoul verbal learning test, delayed recall
Time frame: 3 month
Seoul verbal learning test, delayed recall
Time frame: 3 month
Logical memory test, delayed recall
Time frame: 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jae-Hong Lee, MD,PhD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive training and lifestyle modification in people with Memory Loss, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Paired associates learning test (time frame: 3 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2018.