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
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.).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
64
MCET\_Mock group: Multimodal Cognitive Enhancement Therapy (MCET) (3 sessions/wk) Mock\_MCET group: mock-therapy (3 sessions/wk)
4 weeks wash-out period in both arms and cross-over
MCET\_Mock group: mock therapy (MCET) (3 sessions/wk) Mock\_MCET group: Multimodal Cognitive Enhancement Therapy (MCET) (3 sessions/wk)
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
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)
To evaluate the effect on the global cognition
Time frame: baseline, week8 (after period 1), week 20 (after period 2), 6 months after period 2
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)
To evaluate the effect on global cognition
Time frame: baseline, week8 (after period 1), week 20 (after period 2), 6 months after period 2
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)
To evaluate the effect on the functional level (basic/instrumental activities of daily living)
Time frame: baseline, week8 (after period 1), week 20 (after period 2), 6 months after period 2
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)
To evaluate the effect on the behavioral and psychological symptoms of dementia
Time frame: baseline, week8 (after period 1), week 20 (after period 2), 6 months after period 2
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)
To evaluate the effect on the patient's self-rating quality of life
Time frame: baseline, week8 (after period 1), week 20 (after period 2), 6 months after period 2
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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)
To evaluate the effect on the patient's quality of life evaluated by his/her caregivers
Time frame: baseline, week8 (after period 1), week 20 (after period 2), 6 months after period 2