NL-OMON37828撤回不适用
A Biomarker Study to Measure CSF Proteins Upon Application of an Indwelling Lumbar Catheter for 36 Hours in Subjects with Mild Cognitive Impairment or Alzheimer*s Disease - CSF biomarker study in patients with MCI or Alzheimer's Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 20
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
- •o Diagnosis of probable or possible AD (according to NINCDS-ADRDA)
- •o Mini Mental State Exam score of *18 at screening
- •o Signed informed consent, and subjects must have signed a separate written informed consent indicating willingness to participate in Part 1 genetic testing (required), and indicate either consent or refusal for Part 2 DNA storage (optional)
- •o Mentally capable of understanding the implications of study participation
- •o For MCI subjects only: biological evidence for AD (evidenced by hippocampal atrophy on MRI, positive PIB scan or a positive AD CSF biomarker pattern based on changes on A* (decrease), t-tau and p-tau (increase)
排除标准
- •o Clinically significant abnormal physical- or neurological examination (including fundoscopy), vital signs or 12-lead ECG at screening.
- •o Has a relevant history of lower back pain or scoliosis and/or major (lumbar) back surgery (microdiscectomy is allowed).
- •o Relevant history of or current neurological disease other than AD/MCI (including any history of postdural puncture headache).
- •o History of epilepsy or fits or unexplained black-outs.
- •o History or family history of abnormal bleeding or of blood clotting
- •o History of spontaneous, prolonged or severe bleeding with unclear origin.
- •o Positive screen for drugs or alcohol
- •o Current anemia
- •o Allergic to local anesthetics and/or chlorhexidine.
- •o Inability to refrain from
- •- Low Molecular Weight Heparin (LMWH) treatment within 12 hours prior to spinal
- •- Other anticoagulant treatment (besides LMWH described above) within 1 week prior to spinal catheter insertion.
- •- Aspirin treatment (even low dose) within 5 days prior to spinal catheter insertion.
- •o At pre-check:
- •- Topical infection or local dermatological condition at the puncture site prior to puncture (pre-puncture Day 1).
- •- Clinically significant acute illness within 7 days prior to the study
研究者
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