KCT0006834招募中未知
Hospital-based cohort study of aged people with dementia
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 550
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational Study
入排标准
- 年龄范围
- 60?(Year) 至 90?(Year)（—）
- 性别
- All
入选标准
- •1) Adult men and women over the age of 60
- •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) Subjects who are willing and able to cooperate with this study and complete all clinical trial stages
- •Mild cognitive impairment (aMCI)
- •1) Patient or guardian complains of cognitive impairment
- •2) Through an objective neuropsychological test, it was confirmed that cognitive ability including memory is lower than age and education.
- •3) Maintain overall cognitive function
- •4) No disruption to daily life
- •5) It must not be dementia according to the judgment of the clinician.
- •Alzheimer's dementia patients (AD)
- •1) Probable AD dementia: meets the core clinical criteria in the diagnostic guidelines for AD of NIA-AA
- •Patients with subcortical vascular mild cognitive impairment
- •1) Patient or guardian complains of cognitive impairment
- •2) Through an objective neuropsychological test, it was confirmed that cognitive ability including memory is lower than age and education.
- •3) Maintain overall cognitive function
- •4) No disruption to daily life
- •5) It must not be dementia according to the judgment of the clinician.
- •6) Neurological symptoms in evidence of cerebrovascular disease, such as extrapyramidal signs consistent with subcortical lesions.
- •7) Distinct white matter must be demonstrated 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 local lesions, but not more than an extensive deep white matter change.
- •Patients with subcortical vascular dementia
- •1) Patient or guardian complains of cognitive impairment
- •2) Confirmation of cognitive decline compared to age and education through neuropsychological test
- •3) It must be dementia when judged by the clinician.
- •4) Neurological symptoms in evidence of cerebrovascular disease, such as extrapyramidal signs consistent with subcortical lesions.
- •5) Clear white matter must be demonstrated 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 local lesions, but not more than an extensive deep white matter change.
- •Lewy body mild cognitive impairment patients
- •1) Patient or guardian complains of cognitive impairment
- •2) Through an objective neuropsychological test, it was confirmed that cognitive ability including memory is lower than age and education.
- •3) Maintain overall cognitive function
- •4) No disruption to daily life
- •5) It must not be dementia according to the judgment of the clinician.
- •6) Select subjects suitable for the probable MCI of lewybody according to the diagnostic criteria for Lewy body dementia (McKeith et al, Neurology)
- •Lewy body dementia patients
- •1) Patient or guardian complains of cognitive impairment
- •2) Confirmation of cognitive decline compared to age and education through neuropsychological test
- •3) It must be dementia when judged by the clinician.
- •4) Select subjects eligib
排除标准
- •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 difficulty breathing when sitting still
- •7) Thyroid stimulating hormone (TSH), folic acid, vitamin B12, apoE gene (APOE), RPR test (syphilis test) during blood test
- •A person whose result is an abnormal value and the abnormal value continues even after the relevant treatment
- •8) Those who have had memory impairment, language 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
- •18) Those who are not suitable for MRI examination (claustrophobia, insertion of metal devices in the body, etc.)
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