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

Primary Purpose

Mild Cognitive Impairment, Dementia, Mild

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Period I MCET (8 wks)

Washout (4 wks)

Period II MCET (8 wks)

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Mild cognitive impairment, Dementia, Cognitive training, Cognitive rehabilitation, Cognitive therapy

Eligibility Criteria

55 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

MCET_Mock group

Mock_MCET group

Arm Description

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)

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);

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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)

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

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

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

Full Information

NCT ID

NCT02350738

First Posted

January 21, 2015

Last Updated

July 24, 2015

Sponsor

Ki Woong Kim

Collaborators

Ministry of Health & Welfare, Korea

1. Study Identification

Unique Protocol Identification Number

NCT02350738

Brief Title

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

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Completed

Study Start Date

February 2014 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Ki Woong Kim

Collaborators

Ministry of Health & Welfare, Korea

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mild Cognitive Impairment, Dementia, Mild

Keywords

Mild cognitive impairment, Dementia, Cognitive training, Cognitive rehabilitation, Cognitive therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MCET_Mock group

Arm Type

Experimental

Arm Description

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)

Arm Title

Mock_MCET group

Arm Type

Experimental

Arm Description

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);

Intervention Type

Other

Intervention Name(s)

Period I MCET (8 wks)

Intervention Description

MCET_Mock group: Multimodal Cognitive Enhancement Therapy (MCET) (3 sessions/wk) Mock_MCET group: mock-therapy (3 sessions/wk)

Intervention Type

Other

Intervention Name(s)

Washout (4 wks)

Intervention Description

4 weeks wash-out period in both arms and cross-over

Intervention Type

Other

Intervention Name(s)

Period II MCET (8 wks)

Intervention Description

MCET_Mock group: mock therapy (MCET) (3 sessions/wk) Mock_MCET group: Multimodal Cognitive Enhancement Therapy (MCET) (3 sessions/wk)

Primary Outcome Measure Information:

Title

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)

Description

To evaluate the effect on the global cognition

Time Frame