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Clinical Trials/NCT06355973
NCT06355973
Not Yet Recruiting
N/A

A Pilot Study for Efficacy of Cognitive and Physical Training in Patients With Mild Cognitive Impairment

MinYoung Kim, MD, PhD0 sites24 target enrollmentApril 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Patients With Mild Cognitive Impairment (MCI)
Sponsor
MinYoung Kim, MD, PhD
Enrollment
24
Primary Endpoint
Montreal Cognitive Assessment (MoCA)
Status
Not Yet Recruiting
Last Updated
2 years ago

Overview

Brief Summary

This is to find out the effectiveness of cognitive and physical function training for patients with mild cognitive impairment.

It is for the prevention and treatment of dementia in the future. randomized, Pilot Study.

Registry
clinicaltrials.gov
Start Date
April 2024
End Date
December 31, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
MinYoung Kim, MD, PhD
Responsible Party
Sponsor Investigator
Principal Investigator

MinYoung Kim, MD, PhD

Sponsor-Investigator

Bundang CHA Hospital

Eligibility Criteria

Inclusion Criteria

  • men and women aged 60 or older
  • A person who falls within the abnormal range of the Montreal Cognitive Assessment (MoCA) test
  • a person who can independently carry out daily life
  • If the subject or legal representative voluntarily decides to participate and agrees in writing to comply with the precautions after hearing and fully understanding the detailed explanation of this clinical study

Exclusion Criteria

  • A person diagnosed with Alzheimer's dementia or other causes (stroke, brain tumor, cerebral palsy, dementia, Parkinson's disease, etc.)
  • A person with unstable cardiovascular system, digestive system, respiratory system, endocrine system, etc. and poor general condition
  • Patients who have participated in other treatment clinical studies or who have participated in other treatment clinical studies within the last 30 days
  • Other cases where the researcher determines that participation in this clinical study is not appropriate

Outcomes

Primary Outcomes

Montreal Cognitive Assessment (MoCA)

Time Frame: screening - 6 weeks - 3 months

K-MoCA is a measure of memory loss or other symptoms of cognitive decline. It includes 30 questions and a task that takes about 12 minutes to complete. The score can range from 0 to 30. A score of 26 or higher is considered normal.

Secondary Outcomes

  • Clinical Global Impressions of Change (CGIC)(Baseline - 6 weeks- 3months)
  • Geriatric Quality of Life-Dementia (GQOL-D)(Baseline - 6 weeks- 3months)
  • Geriatric Depression Scale (GDSd)(Baseline - 6 weeks- 3months)
  • Global Deterioration Scale (GDS)(Baseline - 3months)
  • Clinical Dementia Rating (CDR)(Baseline - 3months)
  • Korean-Mini Mental Status Examination (K-MMSE)(Baseline - 6 weeks - 3months)
  • Berg Balance Scale (BBS)(Baseline - 6 weeks- 3months)
  • Instrumental Activities of Daily Living (I-ADL)(Baseline - 6 weeks- 3months)
  • Electroencephalography(Baseline - 6 weeks- 3months)

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