NL-OMON56755尚未招募不适用
An investigator-initiated prospective, longitudinal, single center, observational study to investigate biomarkers of TDP-43 and oxidized lipid metabolism in Amyotrophic Lateral Sclerosis (ALS). - ALS-Biomarker Study
niversitair Medisch Centrum Utrecht0 个研究点目标入组 70 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
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
- 18 至 99（—）
入选标准
- •- Signed informed consent
- •- Age above 18 years
- •- Diagnosis ALS
排除标准
- •- Fulfilling the criteria for respiratory insufficiency (non-invasive
- •ventilation use >23 hours per day for 10 consecutive days or having a
- •tracheostomy)
- •- MiToS stage 2, 3 or 4
- •- confirmed FUS or SOD1 mutation
- •- Contraindication to lumbar puncture
- •- Any of the following medically significant conditions:
- •1. Neurological impairment/dysfunction or unstable psychiatric illness that in
- •the investigator*s opinion is likely to interfere with assessment of ALS
- •disease progression.
- •2. Clinically significant unstable medical condition other than ALS, which
- •would present a risk to a patient to participate in the study
- •3. Presence of dementia that impairs the ability of the subject to provide
- •informed consent, according to the PI decision.
- •4. Cancer that is currently under active treatment or is likely to require
- •treatment during the study that may alter the subject*s function and thereby
- •interfere with assessment of ALS disease progression.
- •5. Any other condition that in the investigator*s opinion would present a risk
- •to a patient to participate in the study, interfere with the assessment of
- •safety or has an increased risk of causing death during the study.
研究者
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