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NCT Number: NCT02350738

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

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

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Key information

Conditions

Mild Cognitive Impairment Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Dementia, Mild Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Mental Disorders Neoplasms Neoplasms by Histologic Type Nervous System Diseases Neurocognitive Disorders

Age range

55 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Bundang Hospital

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

About this study

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.).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Washout (4 wks)

Other

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

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)

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)

    Time frame: baseline, week8 (after period 1), week 20 (after period 2), 6 months after period 2

    To evaluate the effect on the global cognition

Secondary outcomes

  1. 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)

    Time frame: baseline, week8 (after period 1), week 20 (after period 2), 6 months after period 2

    To evaluate the effect on global cognition

  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)

    Time frame: 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)

  3. 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)

    Time frame: 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

  4. 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)

    Time frame: 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

  5. 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)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Ki Woong Kim

Other

Collaborators

  • Ministry of Health & Welfare, Korea

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 30, 2015
Registry last updated
Jul 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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