Completed

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

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What is being tested

Phase I U-SMART (4 wks)

+ Washout (2 wks)

+ Washout (2 wks)

DeviceOther
Who is being recruted

Mental Disorders+8

+ Brain Diseases

+ Central Nervous System Diseases

From 55 to 90 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: August 2012
See protocol details

Summary

Principal SponsorSeoul National University Bundang Hospital
Last updated: April 20, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01688128
Principal SponsorSeoul National University Bundang Hospital
Last updated: April 20, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 55 to 90 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersBrain DiseasesCentral Nervous System DiseasesCognition DisordersDementiaNervous System DiseasesNeurodegenerative DiseasesNeurocognitive DisordersTauopathiesAlzheimer DiseaseCognitive Dysfunction

Criteria

4 inclusion criteria required to participate
Aged 55-90
Clinical Dementia Rating (CDR) of 0 or 0.5
Diagnosed to mild cognitive impairment by International Working Group on Mild Cognitive Impairment
Educational level above 1 year and confirmed literacy
8 exclusion criteria prevent from participating
Any neurological conditions causing cognitive decline such as Parkinson's disease, brain hemorrhage, brain tumor, normal pressure hydrocephalus
Diagnosed to dementia by DSM-IV
Evidence of delirium, confusion
Evidence of severe cerebrovascular pathology
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Seoul National University Bundang Hospital

Seongnam-si, South KoreaOpen Seoul National University Bundang Hospital in Google Maps
CompletedOne Study Center