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

Ki Woong Kim

Status and phase: Completed; Phase 3

Conditions: Dementia, Mild; Mild Cognitive Impairment

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02350738

SeoulNUBH

Details and patient eligibility

About

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

Full 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.).

Enrollment: 64 patients

Sex: All

Ages: 55 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

64 participants in 2 patient groups

MCET_Mock group

Experimental group

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)

Treatment:

Other: Washout (4 wks)

Other: Period I MCET (8 wks)

Mock_MCET group

Experimental group

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);

Treatment:

Other: Washout (4 wks)

Other: Period II MCET (8 wks)