Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training

Mild Cognitive Impairment Clinical Trial

— U-SMART  

Official title:

Feasibility and Efficacy of the Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training (U-SMART) on Mild Cognitive Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01628653
• Other study ID #: 06-2011-084
• Status: Completed
• Phase: Phase 1
• First received: June 23, 2012
• Last updated: June 23, 2012
• Start date: June 2011
• Est. completion date: February 2012

Study information

• Verified date: June 2012
• 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 feasibility and efficacy of the Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training (U-SMART) in the elderly individuals with mild cognitive impairment (MCI).

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 was examined its feasibility and efficacy in the elderly individuals with mild cognitive impairment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• 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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Mild Cognitive Impairment

Intervention

Device:
• U-SMART
4-weeks' training

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	the five-point Likert scales for satisfaction and compliance	To evaluate the feasibility of the U-SMART, the five-point Likert scales for satisfaction and compliance were applied to all participants.	after 4-weeks treatment	No
Primary	Word List Memory Test of the CERAD Neuropsychological Assessment Battery	To evaluate the efficacy of the U-SMART, the Word List Memory Test (WLMT) of the CERAD neuropsychological assessment battery was applied to all participants.	after 4-weeks treatment	No
Secondary	Mini-Mental State Examination (MMSE)		after 4-weeks treatment	No