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

Mild Cognitive Impairment Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02350738
• Other study ID #: SeoulNUBH
• Status: Completed
• Phase: Phase 3
• First received: January 21, 2015
• Last updated: July 24, 2015
• Start date: February 2014
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Dementia
• Dementia, Mild
• Mild Cognitive Impairment

Intervention

Other:
• Period I MCET (8 wks)
MCET_Mock group: Multimodal Cognitive Enhancement Therapy (MCET) (3 sessions/wk) Mock_MCET group: mock-therapy (3 sessions/wk)
• Washout (4 wks)
4 weeks wash-out period in both arms and cross-over
• Period II MCET (8 wks)
MCET_Mock group: mock therapy (MCET) (3 sessions/wk) Mock_MCET group: Multimodal Cognitive Enhancement Therapy (MCET) (3 sessions/wk)

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi

Sponsors (2)

Lead Sponsor	Collaborator
Ki Woong Kim	Ministry of Health & Welfare, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No