DRKS00011816招募中不适用
HDClarity: a multi-site cerebrospinal fluid collection initiative to facilitate therapeutic development for Huntington’s disease - HDClarity
CL Institute of NeurologyNational Hospital for Neurology & Neurosurgery0 个研究点目标入组 600 人开始时间: 2017年3月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
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
- 21 Years 至 75 Years（—）
- 性别
- All
入选标准
- •All eligible participants
- •a. Are 21-75 years of age, inclusive; and
- •b. Are capable of providing informed consent or have a legal representative
- •authorized to give consent on behalf of the participant; and
- •c. Are capable of complying with study procedures, including fasting, blood
- •sampling and lumbar puncture; and
- •d. Are participating in the Enroll-HD study; and
- •e. Will have had an Enroll-HD visit within three months of the Sampling Visit.
排除标准
- •a. Current use of investigational drugs or participation in a clinical drug trial within
- •30 days prior to Sampling Visit; or
- •b. Current intoxication, drug or alcohol abuse or dependence; or
- •c. If using any antidepressant, psychoactive, psychotropic or other medications or
- •nutraceuticals used to treat HD, the use of inappropriate (e.g., nontherapeutically
- •high) or unstable dose within 30 days prior to Sampling Visit;
- •d. Significant medical, neurological or psychiatric co-morbidity likely, in the
- •judgment of the Site Principal Investigator, to impair participant’s ability to
- •complete study procedures; or
- •e. Needle phobia, frequent headache, significant lower spinal deformity or major
- •surgery; or
- •f. Antiplatelet or anticoagulant therapy within the 14 days prior to sampling visit,
- •including but not limited to: aspirin, clopidogrel, dipyridamole, warfarin,
- •dabigatran, rivaroxaban and apixaban; or
- •g. Clotting or bruising disorder; or
- •h. Screening blood test results outside the lab’s normal range for the following:
- •white cell count, neutrophil count, lymphocyte count, hemoglobin (Hb),
- •platelets, prothrombin time (PT) and activated partial thromboplastin time
- •i. Screening blood test results for C-reactive protein (CRP)>2× upper limit of
- •j. Predictable non-compliance as assessed by Site Principal Investigator; or
- •k. Inability or unwillingness to undertake any of the study procedures
研究者
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