NL-OMON53525尚未招募2 期
Imaging inflammation in Alzheimer*s Disease - InflamAD
Amsterdam UMC0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
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
- •Group 1: subjects along the AD continuum
- •In order to be eligible to participate in this study, a subject must meet all
- •of the following criteria:
- •1. Be along the AD continuum, defined as having positive biomarker evidence
- •(CSF or PET) for the presence of Aβ pathology.
- •2. At least 50 years of age;
- •3. Subjects must, in the opinion of the principal investigator/attending
- •neurologist, be able to tolerate study procedures and be competent to make a
- •well-informed decision to participate in this study;
- •4. Signed informed consent for Amsterdam Dementia Cohort (2016.061);
- •Group 2: cognitively unimpaired subjects
- •In order to be eligible to participate in this study, a subject must meet all
- •of the following criteria:
- •1. Have biomarker evidence (CSF or PET) for the absence of Aβ pathology;
- •2. Have no objective cognitive impairment as determined by a neuropsychologist
- •or neuropsychological testing;
- •3. At least 50 years of age;
- •4. Subjects must, in the opinion of the principal investigator/attending
- •neurologist, be able to tolerate study procedures and be competent to make a
- •well-informed decision to participate in this study.
- •5. Signed informed consent for Amsterdam Dementia Cohort (2016.061);
排除标准
- •1. Has contra indications for MRI scanning and therefore cannot receive a brain
- •2. Has evidence of (gross) structural abnormalities such as major stroke or
- •mass on MRI that is likely to interfere with interpretation of PET scan;
- •3. Inability to undergo PET-CT with administration of radioligand [11C]SMW139;
- •4. Is a woman of childbearing potential who is not surgically sterile, not
- •refraining from sexual activity or not using reliable methods for
- •contraception. Women of childbearing potential must not be pregnant or breast
- •feeding at screening and at imaging;
- •5. Has a relevant history of severe drug allergy or hypersensitivity. This
- •includes (but is not limited to) hay fever, allergies to cats and dogs, and
- •dust mite allergy. Other relevant severe drug allergies or hypersensitivities
- •should be evaluated by the Principal Investigator;
- •6. Has ever participated in an experimental study with a tau, amyloid or
- •neuroinflammation targeting agent, unless it can be documented that the subject
- •received only placebo during the course of the trial;
- •7. History of any clinically significant cardiovascular, endocrinology,
- •hematologic, hepatobiliary, immunologic, inflammatory, metabolic, urologic,
- •pulmonary (including asthma), neurologic (with the exception of AD),
- •psychiatric, renal or other major disease, as determined by the principal
- •investigator;
- •8. In male subjects Hb < 8.0 g/dL, in female subjects Hb < 7.0 g/dL;
- •9. Has been injected with a previously administered radiopharmaceutical within
- •6 terminal half-lives OR when total yearly radiation exposure exceeds 10 mSv;
- •10. Has a history of severe traumatic brain injury (TBI);
- •11. The following medications during the study and 4 weeks prior to [11C]SMW139
- •a. Use of anticonvulsant medications;
- •b. Anti-inflammatory medications (e.g. chronic NSAID use);
- •c. Other medications that, in the opinion of the investigator, may interfere
- •with the study.
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