A Phase 3 interventional study of Phase I U-SMART (4 wks) and Washout (2 wks) in Mild Cognitive Impairment, sponsored by Seoul National University Bundang Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 55 Years to 90 Years. Per ClinicalTrials.gov, last updated 2016-04-20.
Sponsored by Seoul National University Bundang Hospital · Phase 3, Interventional, and Treatment
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.
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.
3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.
This study's enrollment of 50 is below the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →Seoul National University Bundang Hospital is the lead sponsor of 368 studies on the registry; 55 are open to participants now.
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Exclusion Criteria:
Phase I: U-SMART for 4 weeks (2 session/week); Washout: for 2 weeks; Phase II: No intervention for 4 weeks
Device: Phase I U-SMART (4 wks) · Other: Washout (2 wks)
Phase I: No intervention for 4 weeks; Washout: for 2 weeks; Phase II: U-SMART for 4 weeks (2 session/week)
Other: Washout (2 wks) · Device: Phase II U-SMART (4 wks)
Intervention_Control Group, 4-weeks U-SMART(2 session/week); Control_Intervention Group, no intervention
2-weeks wash out period in both arms
Intervention_Control Group, no intervention; Control_Intervention Group, 4-weeks U-SMART(2 session/week, Crossover design)
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.
Time frame: Baseline, 5 weeks, 11weeks
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.
Time frame: Baseline, 5 weeks, 11weeks
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.
Time frame: Baseline, 5 weeks, 11weeks
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.
Time frame: Baseline, 5 weeks, 11weeks
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Seoul National University Bundang Hospital