JPRN-jRCTs041220064招募中2 期
Study on the utility of next-generation olfactometry in patients and at-risk subjects of Lewy body disease
Katsuno Masahisa0 个研究点目标入组 60 人开始时间: 2022年9月20日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(A) Patients with Lewy body disease (Parkinson's disease or dementia with Lewy bodies)
- •(1) Subjects whose age is 20 years old or more
- •(2) Subjects who fulfill MDS Clinical Diagnostic Criteria for PD (Clinically established PD) or criteria for the clinical diagnosis of probable and possible dementia with Lewy bodies (Probable DLB)
- •(3) Subjects who can make an outpatient visit
- •(4) Subjects or proxies who agree to participate in this study
- •(B) At-risk subjects of Lewy body disease
- •(1) Subjects whose age is 20 years old or more
- •(2) Subjects who have two or more prodromal symptoms:
- •SCOPA-AUT >= 10
- •OSIT-J <= 7 or SAOQ <= 90%
- •RBDSQ >= 5 or REM sleep without atonia (RWA) finding of polysomnography
- •(3) Subjects who are not diagnosed with Parkinson's disease or dementia with Lewy bodies
- •(4) Subjects who can make an outpatient visit
- •(5) Subjects who agree to participate in this study
- •(C) Healthy controls
- •(1) Subjects whose age is 20 years old or more
- •(2) Subjects who fulfill all of the following criteria:
- •SCOPA-AUT <= 9
- •SAOQ >= 90%
- •RBDSQ <= 4
- •(3) Subjects who are not diagnosed with Parkinson's disease or dementia with Lewy bodies
- •(4) Subjects who can make an outpatient visit
- •(5) Subjects who agree to participate in this study
排除标准
- •(1) Subjects with severe hyposmia due to nasal disorders
- •(2) Subjects with severe heart disease (myocardial infarction, angina, etc.)
- •(3) Subjects with severe hepatic or renal dysfunction
- •(4) Subjects with mental or neurological disorders other than depression
- •(5) Subjects with other severe complications
- •(6) Female subjects who are pregnant or breast-feeding
- •(7) Subjects who disagree with contraception during the study period
- •(8) Subjects diagnosed with other neurological disorders using brain MRI at screening or before
- •(9) Subjects who are inappropriate to participate in the study
- •(10) Subjects who participate in other clinical trials. Development of prodromal biomarkers with Parkinson's disease and dementia with Lewy bodies by analyzing body fluid and medical records and Prospective study on early diagnosis of Parkinson's disease in medical checkup examinees with non-motor symptoms (NaT-PROBE) is excluded.
研究者
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