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Active Not Recruiting NCT07101380

Feasibility Study of 'SuperBrain BOOM' for Mild Cognitive Impairment Patients

Conditions: Mild Cognitive Impairment (MCI)

Sex: All
Ages: 50 Years – 85 Years
Healthy volunteers: No
Phase: NA
Enrollment: 45
Sponsor: Ajou University School of Medicine

Location: Bundang CHA General Hospital Seongnam-si Gyeonggi-do

Summary

The goal of this clinical trial is to learn whether a mobile-based personalized physical activity program called SuperBrain BOOM is safe and works to improve cognitive function, physical performance, mood, and quality of life in older adults (ages 50-85) with mild cognitive impairment (MCI). The main questions it aims to answer are: Can SuperBrain BOOM be safely and effectively used by people with MCI? Does the program help improve cognitive and physical function? Do participants stay engaged and complete the program as expected? Researchers will compare: A mobile intervention group using SuperBrain BOOM (on tablet or smartphone) A control group receiving usual care Participants will: Use a tablet or smartphone to follow a personalized physical activity program for 12 weeks Complete clinical assessments on cognition, physical ability, mood, and nutrition Be monitored for safety and program adherence using automatically collected data

Eligibility Criteria

Inclusion Criteria: 1. Age: Between 50 and 85 years old. 2. Meets all of the core clinical criteria for suspected Mild Cognitive Impairment (MCI) according to the National Institute on Aging-Alzheimer's Association (NIA-AA) guidelines as of the screening date: * Concerns of the participant or caregiver regarding cognitive decline compared to prior functioning. * Impairment in at least one cognitive domain. * Preserved independence in overall daily living activities. * No dementia. 3. Has one or more of the following neuropsychological test results within one year of the screening date, with delayed recall scores in the memory domain below the mean -1.0 standard deviation according to age- and education-adjusted normative data: * Seoul Neuropsychological Screening Battery 2nd Edition (SNSB-II) * Korean version of the Consortium to Establish a Registry for Alzheimer's Disease (CERAD-K) * Literacy Independent Cognitive Assessment (LICA) 4. As of the screening date, has a Korea-Mini Mental State Examination (K-MMSE-2) score that corresponds to at least -1.5 standard deviations below the mean based on age- and education-adjusted normative data. 5. As of the screening date, has a Global Clinical Dementia Rating (CDR) score of 0.5, with a memory score of either 0.5 or 1. 6. Capable of using a tablet or smartphone with training, or has a research partner who can assist with using a tablet or smartphone. 7. Has a caregiver who regularly contacts the participant: -A caregiver who is able to support the participant (monitor compliance and report participant status) and spends at least 8 hours per week with the participant during the trial period. 8. The participant provides written informed consent to participate in the study. Exclusion Criteria: 1. Presence of psychiatric disorders, such as major depression. 2. Dementia. 3. Other neurodegenerative diseases, such as Parkinson's disease. 4. Malignant tumors within the past 5 years that have not been declared cured. 5. Vascular surgery or stent placement within the past year. 6. Severe or unstable symptomatic cardiovascular disease. 7. Evidence of severe or unstable physical conditions, such as acute or severe asthma, active peptic ulcers, severe liver disease, kidney disease requiring dialysis, or any other medical conditions that may interfere with completing the clinical trial. 8. Severe vision impairment, severe hearing loss, or communication difficulties that would prevent the participant from undergoing the intervention or efficacy assessments. 9. Abnormal findings in clinical pathology tests related to cognitive decline, as determined by the clinical investigator (e.g., significant thyroid dysfunction, vitamin B12 or folate deficiency, neurosyphilis, etc.). 10. The investigator's judgment that the participant is unlikely to cooperate fully with the study. 11. The investigator's judgment that the participant has difficulty safely participating in an exercise-based intervention program. 12. Participation in another interventional clinical trial.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07101380). StuddyBuddy aggregates publicly available trial information.