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The efficacy and effectiveness trial of multi-domain intervention program (SUPERBRAIN) to prevent cognitive impairment in patients with mild cognitive impairment and early dementia

The efficacy and effectiveness trial of multi-domain intervention program (SUPERBRAIN) to prevent cognitive impairment in patients with mild cognitive impairment and early dementia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0007253
Enrollment
48
Registered
2022-05-06
Start date
2021-03-02
Completion date
Unknown
Last updated
2022-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Behavioral, Dietary Supplement : In a 1:1:1 ratio, participants were randomly assigned to the treatment group A which is provided with SUPERBRAIN multimodal intervention with ready-made nutritional su

Sponsors

Ewha Womans University Seoul Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age: 65-85 years old 2. Mild cognitive impairment (criteria defined by Petersen, etc.) and probable Alzheimer's disease dementia as clinically diagnosed 3. Simple cognitive function test (K-MMSE) is 17-27. 4. Clinical Dementia Rating: 0.5-1 5. Clinical Dementia Rating Scale, sum of boxes: 0.5-5 6. Having a caregiver who can attend together to interview and the programs 7. Subject agrees to participate in the study with written consent

Exclusion criteria

Exclusion criteria: 1. Organic brain diseases and degenerative diseases that can be a major cause of cognitive declines such as brain tumor, stroke, normal pressure hydrocephalus, Parkinson’s disease, Lewy body dementia, vascular dementia, and autoimmune encephalitis 2. Infective or metabolic disease that may result in cognitive impairment such as neurosyphilis, AIDS dementia, vitamin B12 deficiency, folic acid deficiency, and hypothyroidism 3. Major psychiatric illness 4. Epilepsy with intractable seizure 5. Acute disease state (pneumonia, sepsis, shock, etc.) or acute infective disease 6. Probable encephalopathy due to chronic liver disease or chronic kidney disease 7. Chronic pulmonary disease or cardiovascular disease on treatment 8. Any medical conditions preventing cooperation with the interventions, as determined by a study doctor 9. Significant visual or auditory impairment that may prevent cooperation with the study 10. Illiteracy 11. Inability to participate in the study cooperatively until the end 12. Inability to safely participate in the exercise program 13. Simultaneous participation in any other intervention trial 14. Subject disagrees to participate in the study

Design outcomes

Primary

MeasureTime frame
Total score of RBANS

Secondary

MeasureTime frame
Changes in EEG, gut microbiome, MNA, and blood biomarkers are evaluated as the secondary outcomes.

Countries

Korea, Republic of

Contacts

Public Contactjee hyang jeong

Ewha Womans University Seoul Hospital

jjeong@ewha.ac.kr+82-2-6986-2651

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026