Multidomain Interventions Via Face-to-face and Video Communication Platforms in Mild Cognitive Impairment

Mild Cognitive Impairment Clinical Trial

— SUPERBRAIN  

Official title:

A Multicenter Randomized Controlled Study to Evaluate the Efficacy of a 24-week Multidomain Intervention Via Face-to-face and Video Communication Platforms in Mild Cognitive Impairment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05023057
• Other study ID #: 2021-06-040
• Status: Recruiting
• Phase: N/A
• Start date: September 23, 2021
• Est. completion date: July 2023

Study information

• Verified date: March 2022
• Source: Inha University Hospital
• Contact: Seong Hye Choi, MD, PhD
• Phone: 82 32 890 3659
• Email: seonghye[@]inha.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will be done to investigate the effectiveness of a 24-week multidomain intervention program consisting of cognitive training, exercise, nutrition management, vascular disease risk factor management, social activity, and motivational enhancement on the cognitive function compared to the control group in mild cognitive impairment.

Description:

The physical exercise program will consist of aerobic exercise, exercise to enhance balance and flexibility, muscle-strengthening activities involving major muscle groups, and finger-toe movements. Cognitive training targets the cognitive domains of episodic memory, executive function, attention, working memory, calculation, and visuospatial function. Cognitive training will be conducted using a tablet-based application. Participants will be advised to eat something according to the recommendation of the MIND diet. They will also meet the study nurse every 4 weeks for anthropometric measurements and monitoring of smoking and alcohol intake. The purpose of the motivational enhancement program is to induce, maintain, and strengthen motivation, which is a psychological resource to help maintain dementia prevention activities.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 79 Years

Eligibility

Inclusion Criteria:

• 60 to 79 years of age
• Having at least one modifiable dementia risk factor
• Complaints of cognitive decline by a participant or informant
• A performance score that is lower than 1.0 standard deviations below the age-, and education-adjusted normative means for one or more of the delayed recall, naming, visuoconstruction, attention, and executive function tests
• MMSE Z score = - 1.5
• Independent activities of daily living
• Being able to use the tablet PC through education, or having a person who can help a participant use the tablet PC.
• Having a reliable informant who could provide investigators with the requested information
• Provide written informed consent

Exclusion Criteria:

• Major psychiatric illness such as major depressive disorders
• Dementia
• Other neurodegenerative disease (e.g., Parkinson's disease)
• Malignancy within 5 years
• Cardiac stent or revascularization within 1 year
• Serious or unstable symptomatic cardiovascular disease
• Other serious or unstable medical disease such as acute or severe asthma, active gastric ulcer, severe liver disease, or severe renal disease
• Severe loss of vision, hearing, or communicative disability
• Any conditions preventing cooperation as judged by the study physician
• Significant laboratory abnormality that may result in cognitive impairment
• Illiteracy
• Unable to participate in exercise program safely
• Coincident participation in any other intervention trial

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Behavioral:
• Multidomain intervention
For 24 weeks, participants will receive cognitive training using the tablet PC application twice a week, exercise 3 times a week, nutrition education 12 times, anthropometric measurements and alcohol and smoking monitoring every 4 weeks, motivation reinforcement training 4 times.

Locations

Country	Name	City	State
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	Chonnam University Hospital	Gwangju
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Bobath Memorial Hospital	Seongnam
Korea, Republic of	Ewha Womans Seoul Hospital	Seoul
Korea, Republic of	Konkuk University Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
Inha University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of cognition	Repeatable Battery for the Assessment of Neuropsychological Status (range 40-160). Higher scores indicate better performance.	Change from Baseline at 24 weeks
Secondary	Change of global cognition	Mini-Mental State Examination (range 0-30). Higher scores indicate better performance.	Change from Baseline at 24 weeks
Secondary	Change of function	Clinical Dementia Rating scale-Sum of Boxes (range 0-18). Higher scores indicate worse performance.	Change from Baseline at 24 weeks
Secondary	Change of subjective memory	Prospective and Retrospective Memory Questionnaire (range 16-80). Higher scores indicate worse performance.	Change from Baseline at 24 weeks
Secondary	Change of depression	Geriatric Depression Scale-15 items (range 0-15). Higher scores indicate worse performance.	Change from Baseline at 24 weeks
Secondary	Change of quality of life	Quality of life-Alzheimer's disease (range 0-52). Higher scores indicate better performance.	Change from Baseline at 24 weeks
Secondary	Change of activities of daily living	Bayer Activities of Daily Living (range 1-10). Higher scores indicate worse performance.	Change from Baseline at 24 weeks
Secondary	Change of nutritional behavior	Nutrition Quotient for elderly (range 0-100). Higher scores indicate better performance.	Change from Baseline at 24 weeks
Secondary	Change of nutrition	Mini Nutritional Assessment (range 0-14). Higher scores indicate better performance.	Change from Baseline at 24 weeks
Secondary	Change of motor function	Short Physical Performance Battery (range 0-12). Higher scores indicate better performance.	Change from Baseline at 24 weeks
Secondary	Change of sleep quality	Pittsburgh Sleep Quality Index (range 0-21). Higher scores indicate worse performance.	Change from Baseline at 24 weeks
Secondary	Change of motivation	Self Determination Index (SDI). Higher scores of SDI indicate better performance.	Change from Baseline at 24 weeks. Higher scores indicate better performance.