Mild Cognitive ImpairmentPhase 1U-SMARTNCT01628653
Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training
A Phase 1 study testing U-SMART 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 feasibility and efficacy of the Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training (U-SMART) in the elderly individuals with mild cognitive impairment (MCI). Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- U-SMART
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2011to Feb 2012
- Phase
- Phase 1
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 55-90
- Educational level above 1 year and confirmed literacy
- Diagnosed to mild cognitive impairment by International Working Group on Mild Cognitive Impairment
- Clinical Dementia Rating (CDR) of 0 or 0.5
Who cannot join
- Diagnosed to dementia by DSM-IV
- 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
- History of loss-of-consciousness over 1 hour due to head trauma or repetitive head trauma of mild severity
- History of substance abuse or dependence such as alcohol
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- Presence of depressive symptoms that could influence cognitive function
- Presence of medical comorbidities that could result in cognitive decline
- Use of medication that could influence cognitive function seriously
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: Feasibility and Efficacy of the Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training (U-SMART) on Mild Cognitive Impairment
The purpose of this study is to examine feasibility and efficacy of the Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training (U-SMART) in the elderly individuals with mild cognitive impairment (MCI).
Read the detailed description
The Spaced Retrieval-based Memory Advancement and Rehabilitation Training (SMART) which consisted of 24 one-hour face-to-face sessions (Lee, Park et al. 2009) was developed based on the spaced retrieval training (SRT), which was effective in improving memory retention span of very mild to mild Alzheimer's disease patients. The Ubiquitous SMART (U-SMART) by transforming the current SMART to a self-administered program using an application working on IPAD was developed, and was examined its feasibility and efficacy in the elderly individuals with mild cognitive impairment.
- Conditions
- Mild Cognitive Impairment
- Being tested
- U-SMART
- Keywords
- Mild cognitive impairment, Cognitive rehabilitation, Cognitive therapy, Spaced retrieval Training, Alzheimer's disease, Memory enhancement, U-healthcare
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
U-SMARTDevice
4-weeks' training
| Study group | Role | What they receive |
|---|---|---|
| U-SMART | Experimental | U-SMART (Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training) Receives: Device: U-SMART |
What is being measured
The primary outcome is the main question the study is designed to answer.
the five-point Likert scales for satisfaction and compliance
To evaluate the feasibility of the U-SMART, the five-point Likert scales for satisfaction and compliance were applied to all participants.
Measured: after 4-weeks treatment
Word List Memory Test of the CERAD Neuropsychological Assessment Battery
To evaluate the efficacy of the U-SMART, the Word List Memory Test (WLMT) of the CERAD neuropsychological assessment battery was applied to all participants.
Measured: after 4-weeks treatment
Secondary outcomes (1)
Mini-Mental State Examination (MMSE)
Measured: after 4-weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2012 (estimated)
- Study startJun 2011
- Primary completionFeb 2012
- Study completionFeb 2012
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- KT Corporation
- Responsible party
- Principal investigator, Ki Woong Kim, Seoul National University Bundang Hospital
- Investigators
- Ki Woong Kim, M.D., Ph.D., Principal investigator, Seoul National University Bundang Hospital, Seong-nam, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01628653
- Sponsor's protocol ID
- 06-2011-084
- Acronym
- U-SMART
- Status last verified
- Jun 2012
- First submitted
- 23 Jun 2012
- Last updated
- 27 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Efficacy of the Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training (U-SMART) on Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT01628653
- Acronym / sponsor ID
- U-SMART / 06-2011-084
- Conditions
- Mild Cognitive Impairment
- Keywords
- Mild cognitive impairment, Cognitive rehabilitation, Cognitive therapy, Spaced retrieval Training, Alzheimer's disease, Memory enhancement, U-healthcare
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- KT Corporation
- Study start
- Jun 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 27 Jun 2012 (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.
The purpose of this study is to examine feasibility and efficacy of the Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training (U-SMART) in the elderly individuals with mild cognitive impairment (MCI).
Detailed description
The Spaced Retrieval-based Memory Advancement and Rehabilitation Training (SMART) which consisted of 24 one-hour face-to-face sessions (Lee, Park et al. 2009) was developed based on the spaced retrieval training (SRT), which was effective in improving memory retention span of very mild to mild Alzheimer's disease patients. The Ubiquitous SMART (U-SMART) by transforming the current SMART to a self-administered program using an application working on IPAD was developed, and was examined its feasibility and efficacy in the elderly individuals 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 |
|---|---|---|
| U-SMART | Experimental | Device: U-SMARTU-SMART (Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training) |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 55-90
- Educational level above 1 year and confirmed literacy
- Diagnosed to mild cognitive impairment by International Working Group on Mild Cognitive Impairment
- Clinical Dementia Rating (CDR) of 0 or 0.5
Key exclusion criteria (9 listed)
- Diagnosed to dementia by DSM-IV
- 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
- History of loss-of-consciousness over 1 hour due to head trauma or repetitive head trauma of mild severity
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 |
|---|---|---|
| U-SMART4-weeks' training | Device | U-SMART |
Primary outcome
the five-point Likert scales for satisfaction and compliance
Time frame: after 4-weeks treatment
To evaluate the feasibility of the U-SMART, the five-point Likert scales for satisfaction and compliance were applied to all participants.
Word List Memory Test of the CERAD Neuropsychological Assessment Battery
Time frame: after 4-weeks treatment
To evaluate the efficacy of the U-SMART, the Word List Memory Test (WLMT) of the CERAD neuropsychological assessment battery was applied to all participants.
1 secondary outcome
Mini-Mental State Examination (MMSE)
Time frame: after 4-weeks treatment
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 27 Jun 2012.
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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.
Ki Woong Kim, M.D., Ph.D. principal investigator
Seoul National University Bundang Hospital, Seong-nam, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing U-SMART 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 4 inclusion and 9 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 27 Jun 2012. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
the five-point Likert scales for satisfaction and compliance (time frame: after 4-weeks treatment). The study lists 2 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 27 Jun 2012.