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

Phase 3

Completed

• Conditions: Mild Cognitive Impairment; Dementia, Mild
• Interventions: Other: Period I MCET (8 wks); Other: Period II MCET (8 wks); Other: Washout (4 wks)

• Registration Number: NCT02350738
• Lead Sponsor: Ki Woong Kim

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.).

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2015-01-21
• Study First Submitted QC: 2015-01-26
• Study First Posted: 2015-01-30
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-24
• Last Update Posted: 2015-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Mock_MCET group	Period II MCET (8 wks)	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);
MCET_Mock group	Washout (4 wks)	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	Washout (4 wks)	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);
MCET_Mock group	Period I MCET (8 wks)	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)

Primary Outcome Measures

Name	Time	Method
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)	baseline, week8 (after period 1), week 20 (after period 2), 6 months after period 2	To evaluate the effect on the global cognition

Secondary Outcome Measures

Name	Time	Method
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)	baseline, week8 (after period 1), week 20 (after period 2), 6 months after period 2	To evaluate the effect on the functional level (basic/instrumental activities of daily living)
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)	baseline, week8 (after period 1), week 20 (after period 2), 6 months after period 2	To evaluate the effect on global cognition
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)	baseline, week8 (after period 1), week 20 (after period 2), 6 months after period 2	To evaluate the effect on the patient's quality of life evaluated by his/her caregivers
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)	baseline, week8 (after period 1), week 20 (after period 2), 6 months after period 2	To evaluate the effect on the patient's self-rating quality of life
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)	baseline, week8 (after period 1), week 20 (after period 2), 6 months after period 2	To evaluate the effect on the behavioral and psychological symptoms of dementia

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi, Korea, Republic of