South Korean Study to Prevent Cognitive Impairment and Protect Brain Health Through Lifestyle Intervention

Mild Cognitive Impairment Clinical Trial

— SUPERBRAIN  

Official title:

A Randomized Controlled Study to Evaluate Applicability of Korean Multidomain Intervention Program in the South Korean Study to Prevent Cognitive Impairment and Protect Brain Health Through Lifestyle Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03980392
• Other study ID #: HI18C0479
• Status: Completed
• Phase: N/A
• Start date: May 29, 2019
• Est. completion date: February 25, 2020

Study information

• Verified date: March 2021
• Source: Inha University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates acceptability and efficacy of multidomain intervention program to prevent cognitive impairment and protect brain health in Korean at-risk elderly. A third of participants will receive facility-based intervention for 6 months, a third will receive home-based intervention for 6 months, and a third is waiting list controls.

Description:

Despite extensive research in the field of Alzheimer's disease (AD), no treatment has yet been developed to modify the progression of AD. Therefore, it is important to manage vascular and metabolic risk factors, to eat healthy foods, to exercise, and to participate in social activities to prevent dementia. The FINGER study showed that the multi-domain intervention program is effective to prevent cognitive impairment and disability in elderly. In South Korea, exercise and leisure programs, and brain activity for the elderly also have been conducted in welfare centers and public health centers. However, there are not enough programs that have proven effective in the studies. So the investigators would like to develop a multi-domain intervention program and investigate applicability and efficacy before a large-scale randomized controlled trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: February 25, 2020
• Est. primary completion date: February 14, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 79 Years

Eligibility

Inclusion Criteria:

1. Aged 60-79

2. Having at least one among the following dementia risks,

• hypertension
• Diabetes Mellitus
• Dyslipidemia
• Obesity
• Abdominal obesity
• Metabolic syndrome
• Smoking
• educational level = 9 years
• Physical inactivity
• Social inactivity

3. Independent activities of daily living

4. Mini-Mental State Examination score better than1.5 standard deviations below age and education-adjusted normative means

5. Can read and write Korean

6. Having a reliable informant who could provide investigators with the requested information.

7. Provide written informed consent

Exclusion Criteria:

1. Major psychiatric illness such as major depressive disorders

2. Dementia

3. Substantial cognitive decline

4. Other degenerative disease (e.g., Parkinson's disease)

5. Malignancy within 5 years

6. Cardiac stent or revascularization within 1 year

7. Serious or unstable symptomatic cardiovascular disease

8. Other serious or unstable medical disease such as acute or severe asthma, active gastric ulcer, severe liver disease, or severe renal disease

9. Severe loss of vision, hearing, or communicative disability

10. Any conditions preventing cooperation as judged by the study physician

11. Significant laboratory abnormality that may result in cognitive impairment

12. Unable to participate in exercise program safely

13. Coincident participation in any other intervention trial

Related Conditions & MeSH terms

• Aged
• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Other:
• Multidomain intervention program
Multidomain intervention program for physical exercise, cognitive training, nutrition, vascular and metabolic risk controls, and motivation

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Inha University Hospital	Korea Health Industry Development Institute

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	retention rate (percent) of the participants	Retention rate in each intervention group	6 months
Primary	compliance (percent)	Compliance to the protocol in each intervention group	6 months
Primary	Change of cognition	Repeatable Battery for the Assessment of Neuropsychological Status (sum, range 40-160) / Higher scores mean better cognition.	Change at 6 months from baseline
Secondary	Change of global cognition	Mini-Mental State Examination (sum, range 0-30) / Higher scores mean better cognition.	Change at 6 months from baseline
Secondary	Change of function	Clinical Dementia Rating scale-Sum of Boxes (sum, range 0-18) / Higher scores mean worse function.	Change at 6 months from baseline
Secondary	Change of depression	Geriatric depression scale-15 items (sum, range 0-15) / Higher scores mean worse emotion.	Change at 6 months from baseline
Secondary	Change of subjective memory complaints	Prospective and Retrospective Memory Questionnaire (sum, range 18-80) / Higher scores mean worse memory.	Change at 6 months from baseline
Secondary	Change of memory complaints	Cognitive Complaint Interview (CCI) (sum, range 0-10) / Higher scores mean worse memory.	Change at 6 months from baseline
Secondary	Change of prospective memory	Prospective Memory test (sum, range 0-12) / Higher scores mean better memory.	Change at 6 months from baseline
Secondary	Change of Quality of life (QOL)	QOL-Alzheimer's disease (sum, rage 0-52) / Higher scores mean better QOL.	Change at 6 months from baseline
Secondary	Change of activities of daily livings (ADL)	Bayer-ADL (averaged, rage 1-10) / Higher scores mean worse ADL.	Change at 6 months from baseline
Secondary	Change of nutritional status	Mini Nutritional Assessment (sum, range 0-14) / Higher scores mean better nutrition.	Change at 6 months from baseline
Secondary	Change of nutrition	Nutrition Quotient for Elderly (sum, 0-100) / Higher scores mean better nutrition.	Change at 6 months from baseline
Secondary	Change of balance	Short Physical Performance Battery (sum, range 0-12) / Higher scores mean better physical function.	Change at 6 months from baseline
Secondary	Change of physical activity	Global Physical Activity Questionnaire (This is not scoring.)	Change at 6 months from baseline
Secondary	Change of motivation	Motivation Questionnaire subscore 1) Situational Motivation Type Scale (sum, range 4-28) / Higher scores mean better motivation.; subscore 2) Self-efficacy (sum, range 4-20) / Higher scores mean better motivation.	Change at 6 months from baseline
Secondary	Adverse event (number of participants)	adverse event in each group	Up to 24 weeks