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| Name | Class |
|---|---|
| Ministry of Health & Welfare, Korea | OTHER_GOV |
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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.).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MCET_Mock group | Experimental | Period I: MCET for 8 weeks (3 sessions/ week); Washout for 4 weeks and cross-over; Period II: mock therapy for 8 weeks (3 sessions/week) |
|
| Mock_MCET group | Experimental | Period I: mock therapy for 8 weeks (3 sessions/week); Washout for 4 weeks cross-over; Period II: MCET for 8 weeks (3 sessions/ week); |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Period I MCET (8 wks) | Other | MCET_Mock group: Multimodal Cognitive Enhancement Therapy (MCET) (3 sessions/wk) Mock_MCET group: mock-therapy (3 sessions/wk) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline, week8 (after period 1), week 20 (after period 2), 6 months after period 2 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline, week8 (after period 1), week 20 (after period 2), 6 months after period 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ki Woong Kim, M.D., Ph.D. | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D003704 | Dementia |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001927 | Brain Diseases |
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| Washout (4 wks) | Other | 4 weeks wash-out period in both arms and cross-over |
|
| Period II MCET (8 wks) | Other | MCET_Mock group: mock therapy (MCET) (3 sessions/wk) Mock_MCET group: Multimodal Cognitive Enhancement Therapy (MCET) (3 sessions/wk) |
|
| 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) | 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 | 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 | 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 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 | baseline, week8 (after period 1), week 20 (after period 2), 6 months after period 2 |
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |