Mild Cognitive ImpairmentNCT03928613
Efficacy of the Cognitive Training Based on Location Information and Activity in People With Mild Cognitive Impairment
A study testing tablet based Cognitive Training based on location information in people with Mild Cognitive Impairment, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to examine therapeutic efficacy of cognitive Training based on location information and activity in people with mild cognitive impairment Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- tablet based Cognitive Training based on location information
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Apr 2019to 28 Feb 2020
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged above 60
- Confirmed literacy o Diagnosed with mild cognitive impairment by International Working Group on Mild Cognitive Impairment and Clinical Dementia Rating(CDR) of 0 or 0.5.
Who cannot join
- Evidence of delirium, confusion
- Any neurological conditions causing cognitive decline such as Parkinson's disease, brain hemorrhage, brain tumor, normal pressure hydrocephalus
- Evidence of severe cerebrovascular pathology
- Presence of depressive symptoms that could influence cognitive function
- Presence of medical comorbidities that could result in any difficulties in study participation
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital,
Seongnam-si, Gyeonggi-do, 13620
About this study
The purpose of this study is to examine therapeutic efficacy of cognitive Training based on location information and activity in people with mild cognitive impairment
Read the detailed description
- A single arm, open-label study.
- Cognitive Training based on location information and activity is consists of both cognitive training and exercise(walking) using objects in the participant's home. The researchers visit the participant's home and find objects that were mainly used in the real life and easy to access (table, computer, television, etc.) and attach the recognition Bluetooth Low Energy(BLE) Tag (sticker integrated). The stickers printed on the tags consist of word categories (eg animals) belonging to a particular category, so as to assist strategic recall in the stepped recall task. The participants follow the instruction from the tablet-based program to perform the task. During performing the cognitive training program, the participants are guided to walk between the tagged objects in their home.
- The participants are aged over 60 years old and diagnosed with mild cognitive impairment.
- Conditions
- Mild Cognitive Impairment
- Being tested
- tablet based Cognitive Training based on location information
- Keywords
- Cognitive training, Cognitive intervention, Cognitive rehabilitation
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tablet based Cognitive Training based on location informationBehavioural
Participants perform Tablet based Cognitive training using interactive voice services and tags three times (minimum 30 minutes per time) a week for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Mild Cognitive Impairment | Experimental | * Clinical dementia rating 0 or 0.5
* Diagnosed by physicians as mild cognitive impairment according to the criteria of International Working Group on Mild Cognitive Impairment Receives: Behavioral: tablet based Cognitive Training based on location information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CERAD-TS1 score
Total Score of the Consortium to Establish a Registry for Alzheimer's Disease (CERAD) Neuropsychological Assessment Battery (CERAD-TS1) . CERAD-TS1 is generated by simply summing the scores of six tests including the 1) Verbal fluency (range 0-24), 2) Boston naming test (0-15), 3) Word List Memory (0-30), 4) Word List Recall (0-10), 5) Word list recognition (0-10), 6) Constructional Praxis (0-11). The range of CERAD-TS1 score is 0 to 100 points), and the higher score represents the better cognitive function.
Measured: baseline and 6 weeks
Secondary outcomes (3)
Change in MMSE score
Mini-Mental State Examination (MMSE), ranged 0-30, the higher score represents the better cognitive function
Measured: baseline and 6 weeks
Change in SMCQ score
Subjective Memory Complaint Questionnaire (SMCQ), ranged 0-14, the higher score represents the more difficulties in memory function for everyday life
Measured: baseline and 6 weeks
Change in GDS score
Geriatric depression scale (GDS), ranged 0-30, the higher score represents the more severe depressive symptoms
Measured: baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2019
- Study start17 Apr 2019
- Primary completion31 Dec 2019
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Information & Communications Technology Planning & Evaluation, Korea
- Responsible party
- Principal investigator, Ji Won Han, Seoul National University Bundang Hospital
- Investigators
- Ji Won Han, M.D., Ph.D., Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03928613
- Sponsor's protocol ID
- B-1903-526-301
- Status last verified
- Mar 2020
- First submitted
- 24 Apr 2019
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Cognitive Training Based on Location Information and Activity in People With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT03928613
- Acronym / sponsor ID
- B-1903-526-301
- Conditions
- Mild Cognitive Impairment
- Keywords
- Cognitive training, Cognitive intervention, Cognitive rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- Institute of Information & Communications Technology Planning & Evaluation, Korea
- Study start
- 17 Apr 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 26 Apr 2019 (actual)
- 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.
The purpose of this study is to examine therapeutic efficacy of cognitive Training based on location information and activity in people with mild cognitive impairment
Detailed description
- A single arm, open-label study.
- Cognitive Training based on location information and activity is consists of both cognitive training and exercise(walking) using objects in the participant's home. The researchers visit the participant's home and find objects that were mainly used in the real life and easy to access (table, computer, television, etc.) and attach the recognition Bluetooth Low Energy(BLE) Tag (sticker integrated). The stickers printed on the tags consist of word categories (eg animals) belonging to a particular category, so as to assist strategic recall in the stepped recall task. The participants follow the instruction from the tablet-based program to perform the task. During performing the cognitive training program, the participants are guided to walk between the tagged objects in their home.
- The participants are aged over 60 years old and diagnosed with mild cognitive impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mild Cognitive Impairment | Experimental | Behavioral: tablet based Cognitive Training based on location information* Clinical dementia rating 0 or 0.5 * Diagnosed by physicians as mild cognitive impairment according to the criteria of International Working Group on Mild Cognitive Impairment |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged above 60
- Confirmed literacy o Diagnosed with mild cognitive impairment by International Working Group on Mild Cognitive Impairment and Clinical Dementia Rating(CDR) of 0 or 0.5.
Key exclusion criteria (5 listed)
- Evidence of delirium, confusion
- Any neurological conditions causing cognitive decline such as Parkinson's disease, brain hemorrhage, brain tumor, normal pressure hydrocephalus
- Evidence of severe cerebrovascular pathology
- Presence of depressive symptoms that could influence cognitive function
- Presence of medical comorbidities that could result in any difficulties in study participation
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 |
|---|---|---|
| tablet based Cognitive Training based on location informationParticipants perform Tablet based Cognitive training using interactive voice services and tags three times (minimum 30 minutes per time) a week for 6 weeks | Behavioural | Mild Cognitive Impairment |
Primary outcome
Change in CERAD-TS1 score
Time frame: baseline and 6 weeks
Total Score of the Consortium to Establish a Registry for Alzheimer's Disease (CERAD) Neuropsychological Assessment Battery (CERAD-TS1) . CERAD-TS1 is generated by simply summing the scores of six tests including the 1) Verbal fluency (range 0-24), 2) Boston naming test (0-15), 3) Word List Memory (0-30), 4) Word List Recall (0-10), 5) Word list recognition (0-10), 6) Constructional Praxis (0-11). The range of CERAD-TS1 score is 0 to 100 points), and the higher score represents the better cognitive function.
3 secondary outcomes
Change in MMSE score
Time frame: baseline and 6 weeks
Change in SMCQ score
Time frame: baseline and 6 weeks
Change in GDS score
Time frame: baseline and 6 weeks
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 18 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Ji Won Han, M.D., Ph.D. principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tablet based Cognitive Training based on location information in people with Mild Cognitive Impairment, run by Seoul National University Bundang Hospital 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 2 inclusion and 5 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 18 Mar 2020. 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?
Change in CERAD-TS1 score (time frame: baseline and 6 weeks). 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 18 Mar 2020.