NL-OMON44332已完成不适用
BIOmarkers for cogNitive Impairment due to Cerebral Amyloid Angiopathy (BIONIC) - BIONIC
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 375
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
- •Important notice: we plan to use left-over body fluids (CSF, serum) from neurological controls and dementia patients. We will not actively recruit new patients in these categories.
- •However, we plan to recruit a maximum of 40 new CAA patients to this study; therefore the inclusion and exclusion criteria listed below only apply to this category of patients. The other patient groups are only listed in this ABR form (see above) for the sake of completeness.;Inclusion criteria for CAA patients:
- •In order to be eligible to participate, a subject must meet the following criteria:
- •- Fulfilment of the modified Boston criteria for CAA (Linn, 2010; Smith, 2003)
- •- Subjects are mentally competent to take a decision on participation.
- •- Written informed consent
- •- Age >55 years
排除标准
- •Important notice: we plan to use left-over body fluids (CSF, serum) from neurological controls and dementia patients. We will not actively recruit new patients in these categories.
- •However, we plan to recruit a maximum of 40 new CAA patients to this study; therefore the inclusion and exclusion criteria listed below only apply to this category of patients. The other patient groups are only listed for the sake of completeness.;Exclusion criteria for CAA patients:
- •- Presence of blood coagulopathy, established by medical history
- •- History of neurological or psychiatric disease
- •- Allergy to local anesthetic agents
- •- Contra-indication for lumbar puncture: medical history of compression of spinal cord, spinal surgery, skin infection, developmental abnormalities in lower spine
- •- Subjects who are currently participating in another study or have participated in a clinical study within the previous 30 days, based on their own report
- •- Subjects with a history of drug or alcohol abuse
- •- Subjects who are part of the study staff personnel or family members of the study staff personnel
- •- Clinical (or previous MRI) evidence of structural (space occupying) cerebral abnormalities that are not compatible with the performance of a lumbar puncture , including malignancies, abscesses or obstructive hydrocephalus.;Contraindications for MRI:
- •- Intracranial clips
- •- Pregnancy
- •- Contra-indications to MR Imaging:
- •* Claustrophobia
- •* Pacemakers and defibrillators
- •* Nerve stimulators
- •* Intraorbital or intraocular metallic fragments
- •* Cochlear implants
- •* Ferromagnetic implants
- •* Hydrocephalus pump
- •* Some intra-uterine device
- •* An iron wire behind the teeth placed before 1995
- •* Permanent make-up
- •* Tattoos above the shoulders
- •* Severe physical restriction / inability to be scanned, such as weight above 120 kg
- •* Difficulty with lying down for 30 minutes
研究者
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