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Mild Cognitive ImpairmentPhase 3NCT02350738

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

A Phase 3 study testing Period I MCET (8 wks), Washout (4 wks) and Period II MCET (8 wks) in people with Mild Cognitive Impairment and Dementia, Mild, run by Ki Woong Kim at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 55 to 90 years
Conditions the study is for
Mild Cognitive Impairment, Dementia, Mild
What is being tested?
Period I MCET (8 wks), Washout (4 wks) and Period II MCET (8 wks)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteSouth Korea
Study dates
Feb 2014to Jun 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 463-707

Other trials in South Korea

About this study

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

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

Read the 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.).

Being tested
Period I MCET (8 wks), Washout (4 wks), Period II MCET (8 wks)
Keywords
Mild cognitive impairment, Dementia, Cognitive training, Cognitive rehabilitation, Cognitive therapy
Medical subject headings
Cognitive Dysfunction, Dementia, Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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)

Study groups in NCT02350738
Study groupRoleWhat they receive
MCET_Mock groupExperimentalPeriod 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)
Receives: Other: Period I MCET (8 wks); Other: Washout (4 wks)
Mock_MCET groupExperimentalPeriod I: mock therapy for 8 weeks (3 sessions/week); Washout for 4 weeks cross-over; Period II: MCET for 8 weeks (3 sessions/ week);
Receives: Other: Washout (4 wks); Other: Period II MCET (8 wks)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (5)

  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)

    To evaluate the effect on global cognition

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

  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)

    To evaluate the effect on the functional level (basic/instrumental activities of daily living)

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

  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)

    To evaluate the effect on the behavioral and psychological symptoms of dementia

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

  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)

    To evaluate the effect on the patient's self-rating quality of life

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

  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)

    To evaluate the effect on the patient's quality of life evaluated by his/her caregivers

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2015 (estimated)
  2. Study startFeb 2014
  3. Primary completionJun 2015
  4. Study completionJun 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02350738
Sponsor's protocol ID
SeoulNUBH
Status last verified
Jul 2015
First submitted
21 Jan 2015
Last updated
28 Jul 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Period I MCET (8 wks), Washout (4 wks) and Period II MCET (8 wks) in people with Mild Cognitive Impairment and Dementia, Mild, run by Ki Woong Kim at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02350738.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2015.

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