Clinical trial NCT02350738: Effects of Multimodal Cognitive Enhancement Therapy (MCET) for Ealy Dementia
Official title: Effects of Multimodal Cognitive Enhancement Therapy (MCET) for People With Mild Cognitive Impairment and Early Stage Dementia: a Randomized, Controlled, Double-blind, Cross-over Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mild Cognitive Impairment
Dementia, Mild
Keywords: Mild cognitive impairment
Dementia
Cognitive training
Cognitive rehabilitation
Cognitive therapy
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health & Welfare, Korea
First posted: 2015-01-30
Enrollment: 64
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: This study evaluates the effects of Multimodal Cognitive Enhancement Therapy (MCET) for people with mild cognitive impairment and early stage dementia by a randomized, controlled (mock-therapy), double-blind, cross-over trial

Detailed description: Multimodal Cognitive Enhancement Therapy (MCET) was developed for cognitive rehabilitation of mild cognitive impairment or ealy dementia. MCET consists of cognitive training, cognitive stimulation, reality orientation, physical therapy, reminiscence therapy and music therapy that obtained 'A' grade of recommendation by SIGN(Scottish Intercollegiate Guidelines Network) for their efficacy (one of the followings: global cognition/specific cognitive domain/mood/activities of daily living/behavioral and psychological symptoms/quality of life) based on the systematic review and meta-analysis performed by our research team.

This study investigated the efficacy of MCET compared with mock-therapy that consisted of random activities that were not based on clinical evidences (e.g., watching TV, conversation etc.).

Eligibility criteria: Inclusion Criteria:

* Aged 55-90
* Diagnosed to dementia by the Diagnostic and Statistical Manual, fourth edition (DSM-IV) or to mild cognitive impairment by International Working Group on Mild Cognitive Impairment
* Clinical Dementia Rating (CDR) of 0 or 0.5 for mild cognitive impairment, 0.5 or 1 for early dementia

Exclusion Criteria:

* Evidence of current delirium, confusion
* Any acute neurological conditions (infectious or inflammatory disorders such as viral, fungal or syphilis) or acute medical conditions
* Current major psychiatric disorder by DSM-IV such as major depressive episode or manic or psychotic episode

Primary outcomes:
measure: Change in the Mini-Mental State Examination for dementia screening before and after period I and before and after period II intervention (crossover part of the study)
timeFrame: baseline, week8 (after period 1), week 20 (after period 2), 6 months after period 2
Secondary outcomes:
measure: Change in the Korean version of Alzheimer's Disease Assessment Scale -cognitive subscale of Korean version (ADAS-KCog) before and after period I and before and after period II intervention (crossover part of the study)
timeFrame: baseline, week8 (after period 1), week 20 (after period 2), 6 months after period 2
measure: Change in the Disability Assessment for Dementia (DAD-K) before and after period I and before and after period II intervention (crossover part of the study)
timeFrame: baseline, week8 (after period 1), week 20 (after period 2), 6 months after period 2
measure: Change in the Revised Memory and Behavior Problems Checklist (RMBPC) before and after period I and before and after period II intervention (crossover part of the study)
timeFrame: baseline, week8 (after period 1), week 20 (after period 2), 6 months after period 2
measure: Change in the Quality of Life-AD (QoL-AD) of patients before and after period I and before and after period II intervention (crossover part of the study)
timeFrame: baseline, week8 (after period 1), week 20 (after period 2), 6 months after period 2
measure: Change in the Quality of Life-AD (QoL-AD) of caregivers before and after period I and before and after period II intervention (crossover part of the study)
timeFrame: baseline, week8 (after period 1), week 20 (after period 2), 6 months after period 2
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
name: Ki Woong Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: