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

NCT01688128 | Completed Phase 3 DMC

• 1 other identifier: E-1207/162-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mild Cognitive Impairment

Keywords

Mild cognitive impairment; Cognitive rehabilitation; Cognitive therapy; Spaced retrieval Training; Alzheimer's disease; Memory enhancement; U-healthcare

Outcome Measures

Primary Outcomes (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.

  Baseline, 5 weeks, 11weeks

Secondary Outcomes (3)

• 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)

  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)

  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)

  Baseline, 5 weeks, 11weeks

Study Arms (2)

Intervention_Control group

EXPERIMENTAL

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)

Control_Intervention group

EXPERIMENTAL

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)

Interventions

Phase I U-SMART (4 wks) DEVICE

Intervention\_Control Group, 4-weeks U-SMART(2 session/week); Control\_Intervention Group, no intervention

Intervention_Control group

Washout (2 wks) OTHER

2-weeks wash out period in both arms

Control_Intervention group; Intervention_Control group

Phase II U-SMART (4 wks) DEVICE

Intervention\_Control Group, no intervention; Control\_Intervention Group, 4-weeks U-SMART(2 session/week, Crossover design)

Control_Intervention group

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead
• KT Corporation: collaborator

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Related Publications (1)

• 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.

  PMID: 28587629 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Study Officials

• Ki Woong Kim, M.D., Ph.D.

  Seoul National University Bundang Hospital, Seong-nam, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, department of neuropsychiatry

Study Record Dates

• First Submitted: September 12, 2012
• First Posted: September 19, 2012
• Study Start: August 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 20, 2016

Record last verified: 2016-04

Locations

KR (1)