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Mild Cognitive ImpairmentPhase 3U-SMARTNCT01688128

Efficacy of Ubiquitous SR-based Memory Advancement and Rehabilitation Training (U-SMART)

A Phase 3 study testing Phase I U-SMART (4 wks), Washout (2 wks) and Phase II U-SMART (4 wks) in people with Mild Cognitive Impairment, run by Seoul National University Bundang Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to examine the efficacy of the Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training (U-SMART) in the elderly individuals with mild cognitive impairment (MCI) by an open-label, controlled, crossover Trial. 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?
Phase I U-SMART (4 wks), Washout (2 wks) and Phase II U-SMART (4 wks)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteSouth Korea
Study dates
Aug 2012to Dec 2015
Phase
Phase 3
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
  • 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

Other trials in South Korea

About this study

Official title: An Open-label, Controlled, Cross-over Trial of Ubiquitous SR-based Memory Advancement and Rehabilitation Training (U-SMART) in Mild Cognitive Impairment

The purpose of this study is to examine the efficacy of the Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training (U-SMART) in the elderly individuals with mild cognitive impairment (MCI) by an open-label, controlled, crossover Trial.

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 showed its feasibility and efficacy in the elderly individuals with mild cognitive impairment in the preliminary study. (ClinicalTrials.gov ID: NCT01628653) To validate the efficacy of the U-SMART, an open-label, controlled, crossover design of clinical trial were planned in this study.

Being tested
Phase I U-SMART (4 wks), Washout (2 wks), Phase II U-SMART (4 wks)
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.

  • Phase I U-SMART (4 wks)Device

    Intervention_Control Group, 4-weeks U-SMART(2 session/week); Control_Intervention Group, no intervention

  • Washout (2 wks)Other

    2-weeks wash out period in both arms

  • Phase II U-SMART (4 wks)Device

    Intervention_Control Group, no intervention; Control_Intervention Group, 4-weeks U-SMART(2 session/week, Crossover design)

Study groups in NCT01688128
Study groupRoleWhat they receive
Intervention_Control groupExperimentalPhase I: U-SMART for 4 weeks (2 session/week); Washout: for 2 weeks; Phase II: No intervention for 4 weeks
Receives: Device: Phase I U-SMART (4 wks); Other: Washout (2 wks)
Control_Intervention groupExperimentalPhase I: No intervention for 4 weeks; Washout: for 2 weeks; Phase II: U-SMART for 4 weeks (2 session/week)
Receives: Other: Washout (2 wks); Device: Phase II U-SMART (4 wks)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in the Word List Test (memory, recall, recognition) of the CERAD Neuropsychological Assessment Battery before and after phase I intervention and before and after phase II intervention (crossover part of the study)

    To evaluate the efficacy of the U-SMART, the Word List Memory Test (WLMT), Word List Recall Test (WLRT), Word List Recognition Test (WLRcT) of the CERAD neuropsychological assessment battery were applied to all participants.

    Measured: Baseline, 5 weeks, 11weeks

Secondary outcomes (3)

  1. Change in the Subjective Memory Complaints Questionnaire (SMCQ) before and after phase I intervention and before and after phase II intervention (crossover part of the study)

    To evaluate the subjective memory improvement after the U-SMART, the Subjective Memory Complaints Questionnaire(SMCQ) was applied to all participants.

    Measured: Baseline, 5 weeks, 11weeks

  2. Change in the Geriatric Depression Scale (GDS) before and after phase I intervention and before and after phase II intervention (crossover part of the study)

    To evaluate the subjective mood after the U-SMART, the Geriatric Depression Scale was applied to all participants.

    Measured: Baseline, 5 weeks, 11weeks

  3. Change in the Mini-Mental State Examination before and after phase I intervention and before and after phase II intervention (crossover part of the study)

    To evaluate the global cognitive function after the U-SMART, the Mini-Mental State Examination was applied to all participants.

    Measured: Baseline, 5 weeks, 11weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01688128
Sponsor's protocol ID
E-1207/162-001
Acronym
U-SMART
Status last verified
Apr 2016
First submitted
12 Sep 2012
Last updated
20 Apr 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Han JW, Son KL, Byun HJ, Ko JW, Kim K, Hong JW, Kim TH, Kim KW. Efficacy of the Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training (USMART) program among patients with mild cognitive impairment: a randomized controlled crossover trial. Alzheimers Res Ther. 2017 Jun 6;9(1):39. doi: 10.1186/s13195-017-0264-8.

    PubMed 28587629

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Phase I U-SMART (4 wks), Washout (2 wks) and Phase II U-SMART (4 wks) 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 8 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 20 Apr 2016. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Change in the Word List Test (memory, recall, recognition) of the CERAD Neuropsychological Assessment Battery before and after phase I intervention and before and after phase II intervention (crossover part of the study) (time frame: Baseline, 5 weeks, 11weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01688128, which also lists 1 linked publication.

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 20 Apr 2016.

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