JPRN-jRCT1020210069招募中未知
A study on improving the diagnostic performance of mild cognitive impairment using Multi-PLD AS
Sasaki Makoto0 个研究点目标入组 190 人开始时间: 2022年2月10日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 190
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- >= 50age old 至 <= 85age old（—）
- 性别
- All
入选标准
- •For all participants:
- •1. Age between 55-85 years (inclusive) at the time of obraining consent or MRI scan.
- •2. MRI scan can be performed within one month from the time of obtaining consent.
- •3. The subject's free and voluntary consent to participate in the study has been obtained after receiving sufficient explanation and understanding.
- •4. Visual and auditory acuity adequate for neuropsychological testing.
- •5. Good general health with no diseases expected to interfere with the study.
- •6. Not pregnant, lactating, or of childbearing potential.
- •7. Mini-Mental State Exam score between 24 and 30 (inclusive).
- •8. Geriatric Depression Scale-15-J less than 6.
- •9. Modified Hachinski less than or equal to 4.
- •10. Not taking any medications that may affect the study.
- •Additional inclusion criteria for MCI subjects:
- •1. Awareness of memory problems, either by themselves or by others.
- •2. General cognition and functional performance sufficiently preserved such that a diagnosis of dementia cannot be made.
- •3. Japanese version of the Montreal Cognitive Assessment score less than or equal to 25.
- •4. Wechsler Memory Scale-Revised Logical Memory II scores less than or equal to the cutoff by years of education:
- •a. <=11 for 16 or more years of education
- •b. <=9 for 10-15 years of education
- •c. <=6 for 0-9 years of education
- •Additional inclusion criteria for control subjects:
- •1. No complaints of memory loss beyond subjects age.
- •2. Normal cognition with no significant impairment of cognitive function or ADL.
- •3. Japanese version of the Montreal Cognitive Assessment score of 26 or above.
- •4. Wechsler Memory Scale-Revised Logical Memory II scores above the cutoff by years of education:
- •a. >=9 for 16 or more years of education
- •b. >=5 for 10-15 years of education
- •c. >=3 for 0-9 years of education
排除标准
- •1. Organic central nervous system disorders, or neurological or psychiatric disorders.
- •2. Presence of pacemakers, deep brain stimulator or other contraindications to MRI.
- •3. Claustrophobia.
- •4. Screening MRI scan with evidence of infection, infarction, other focal lesions, or structural brain abnormalities. Participants with multiple lacunes or lacunes in a critical memory structure are also excluded.
- •5. Schizophrenia, major depression, bipolar disorder within the past 1 year, or history of alcohol or substance abuse or dependence within the past 2 years as described in DSM-IV.
- •6. Psychotic features, agitation or behavioral problems within the last 3 months which could lead to difficulty complying with the protocol.
- •7. Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol.
- •8. Clinically significant abnormalities in B12, or TFTs that might interfere with the study.
- •9. Participation in clinical studies involving neuropsychological measures being collected more than one time per year.
- •10. Other conditions in which the protocol director judges the subject to be inappropriate for the study.
研究者
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