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

NCT02350738 | Completed Phase 3 DMC

• 1 other identifier: SeoulNUBH
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Conditions

Mild Cognitive Impairment; Dementia, Mild

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

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)

Other: Period I MCET (8 wks); Other: Washout (4 wks)

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);

Other: Washout (4 wks); Other: Period II MCET (8 wks)

Interventions

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)

MCET_Mock group

Washout (4 wks) OTHER

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

MCET_Mock group; Mock_MCET group

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)

Mock_MCET group

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ki Woong Kim: lead
• Ministry of Health & Welfare, Korea: collaborator

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Ki Woong Kim, M.D., Ph.D.

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 21, 2015
• First Posted: January 30, 2015
• Study Start: February 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 28, 2015

Record last verified: 2015-07

Locations

KR (1)