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

Seoul National University

Status and phase: Completed; Phase 3

Conditions: Mild Cognitive Impairment

Treatments: Device: Phase II U-SMART (4 wks); Other: Washout (2 wks); Device: Phase I U-SMART (4 wks)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01688128

E-1207/162-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 55 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Intervention_Control group

Experimental group

Description:

Phase I: U-SMART for 4 weeks (2 session/week); Washout: for 2 weeks; Phase II: No intervention for 4 weeks

Treatment:

Other: Washout (2 wks)

Device: Phase I U-SMART (4 wks)

Control_Intervention group

Experimental group

Description:

Phase I: No intervention for 4 weeks; Washout: for 2 weeks; Phase II: U-SMART for 4 weeks (2 session/week)

Treatment:

Device: Phase II U-SMART (4 wks)

Other: Washout (2 wks)