Effects of Multimodal Cognitive Enhancement Therapy (MCET) for Ealy Dementia

Study Overview
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Brief Summary
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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

Detailed Description
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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.).

Official Title
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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

Conditions
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Mild Cognitive Impairment, Dementia, Mild

Intervention / Treatment
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* Other: Period I MCET (8 wks)
* Other: Washout (4 wks)
* Other: Period II MCET (8 wks)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MCET_Mock group<br>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) | Other: Period I MCET (8 wks)<br>* MCET_Mock group: Multimodal Cognitive Enhancement Therapy (MCET) (3 sessions/wk) Mock_MCET group: mock-therapy (3 sessions/wk)<br>Other: Washout (4 wks)<br>* 4 weeks wash-out period in both arms and cross-over<br>|
| Experimental: Mock_MCET group<br>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); | Other: Washout (4 wks)<br>* 4 weeks wash-out period in both arms and cross-over<br>Other: Period II MCET (8 wks)<br>* MCET_Mock group: mock therapy (MCET) (3 sessions/wk) Mock_MCET group: Multimodal Cognitive Enhancement Therapy (MCET) (3 sessions/wk)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mild cognitive impairment, Dementia, Cognitive training, Cognitive rehabilitation, Cognitive therapy