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

Mild Cognitive Impairment Clinical Trial

— U-SMART  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01688128
• Other study ID #: E-1207/162-001
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2012
• Last updated: April 18, 2016
• Start date: August 2012
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Mild Cognitive Impairment

Intervention

Device:
• Phase I U-SMART (4 wks)
Intervention_Control Group, 4-weeks U-SMART(2 session/week); Control_Intervention Group, no intervention

Other:
• Washout (2 wks)
2-weeks wash out period in both arms

Device:
• Phase II U-SMART (4 wks)
Intervention_Control Group, no intervention; Control_Intervention Group, 4-weeks U-SMART(2 session/week, Crossover design)

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital	KT Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 5 weeks, 11weeks	No
Secondary	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.	Baseline, 5 weeks, 11weeks	No
Secondary	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.	Baseline, 5 weeks, 11weeks	No
Secondary	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.	Baseline, 5 weeks, 11weeks	No