Clinical trial NCT01688128: Efficacy of Ubiquitous SR-based Memory Advancement and Rehabilitation Training (U-SMART)
Official title: An Open-label, Controlled, Cross-over Trial of Ubiquitous SR-based Memory Advancement and Rehabilitation Training (U-SMART) in Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mild Cognitive Impairment
Keywords: Mild cognitive impairment
Cognitive rehabilitation
Cognitive therapy
Spaced retrieval Training
Alzheimer's disease
Memory enhancement
U-healthcare
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: KT Corporation
First posted: 2012-09-19
Enrollment: 50
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: Baseline, 5 weeks, 11weeks
Secondary outcomes:
measure: 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)
timeFrame: Baseline, 5 weeks, 11weeks
measure: 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)
timeFrame: Baseline, 5 weeks, 11weeks
measure: 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)
timeFrame: Baseline, 5 weeks, 11weeks
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
Study officials:
affiliation: Seoul National University Bundang Hospital, Seong-nam, Korea
name: Ki Woong Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.