Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training

NCT01628653 | Completed Phase 1 DMC

• 1 other identifier: 06-2011-084
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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).

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 (2)

• 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

• 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

Secondary Outcomes (1)

• Mini-Mental State Examination (MMSE)

  after 4-weeks treatment

Study Arms (1)

U-SMART

EXPERIMENTAL

U-SMART (Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training)

Device: U-SMART

Interventions

U-SMART DEVICE

4-weeks' training

U-SMART

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

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 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, department of neuropsychiatry

Study Record Dates

• First Submitted: June 23, 2012
• First Posted: June 27, 2012
• Study Start: June 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: June 27, 2012

Record last verified: 2012-06

Locations

KR (1)