Establishment of precision medicine platform for early diagnosis of mild cognitive impairment
- Conditions
- Diseases of the nervous system
- Registration Number
- KCT0008093
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1000
1. Adult men and women over the age of 45
2. After listening to and fully understanding the detailed explanation of this study, the subject or legal representative voluntarily decides to participate in the study and gives written consent
Subjective Cognitive Dysfunction (SCD)
1. MMSE score above mean-1 SD when considering age, gender, and education level
2. A willing and viable subject to cooperate with this study and complete all clinical trial stages
Mild cognitive impairment (MCI)
1. Patient or guardian complains of cognitive impairment
2. Confirmation that cognitive ability including memory is lower than age and education through neuropsychological test (aMCI) Disorder (naMCI)
3. Maintain overall cognitive function
4. No disruption to daily life
5. Dementia must not be determined by the clinician.
Alzheimer's type dementia patients (AD)
1. Probable AD dementia in the NIA-AA diagnostic guidelines for AD: Patients who satisfy the core clinical criteria and have an MMSE score of 10 or higher
Frontotemporal dementia (FTD) dementia
1. FTD includes bvFTD, nfvPPA, svPPA, according to their respective criteria.
- bvFTD: according to the standard suggested by Bruce miller et al.
- svPPA, nfvPPA : M.L. According to the criteria suggested by Gorno-Tempini et al.
Exclusion from this study is required if one or more of the following conditions are met
1) Patients with neurological abnormalities that may cause memory impairment on medical examination
2) Those with a history of uniaxial psychiatric disorders including intellectual disability, schizophrenia, alcoholism, and bipolar disorder in the past
3) Those with a history of malignant disease (cancer) within the last 3 years. Except for cervical carcinoma in situ or non-melanoma skin cancer.
4) Those who have undergone cerebrovascular surgery, such as brain surgery or carotid artery surgery
5) Those who have neurological symptoms that are evidence of cerebrovascular disease, such as extrapyramidal signs consistent with subcortical lesions.
6) Those who have clear white matter on MRI. Distinctive white matter should conform to the following definition. Periventricular lesions measured in parallel with the ventricles should be 10 mm or more (extended cap) or an irregular edge and an irregular halo of more than 10 mm (irregular halo). change) or a local lesion, but more than an extensive deep white matter change.
7) Those who have difficulty breathing when sitting still
8) Those who have had memory impairment, speech impairment, or problem-solving ability for more than 2 hours after a heart attack
9) Those who have been hospitalized for mental or emotional illness within the past 5 years
10) Those with a history of drug abuse within the last 5 years
11) Those with a history of treatment for alcoholism within the past 5 years
12) Those who have lost consciousness for more than 1 hour due to causes other than general anesthesia
13) Those who have been hospitalized with head injuries
14) Those who cannot read normally even with glasses due to reduced vision
15) Those who have difficulty understanding conversations due to hearing impairment even with hearing aids
16) Pregnant and lactating women
17) Other investigators who are judged inappropriate to participate in clinical trials
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Demographic, clinical information (neuropsychological test, blood test, brain imaging test, genetic test)
- Secondary Outcome Measures
Name Time Method Demographic, clinical information (neuropsychological test, blood test, brain imaging test, genetic test)