EUCTR2017-000094-36-SE进行中(未招募)1 期
The BioFINDER 2 study - improved diagnostics and increased understanding of the pathophysiology of cognitive disorders
Skåne University Hospital0 个研究点开始时间: 2017年1月30日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Healthy elderly subjects
- •- No cognitive symptoms reported by study participant
- •- Normal performance on cognitive tests
- •- General cognition and functional performance preserved such that a
- •diagnosis of MCI or dementia cannot be made by physician at the time of the baseline visit
- •- Between 20 and 100 years of age
- •- Fluent in Swedish
- •- Agrees to at least one lumbar puncture, MRI scan of the brain and neuropsychological testing.
- •Mild cognitive impairment/dementia
- •- Cognitive symptoms reported by patient and/or informant
- •- Between 20 and 100 years of age
- •- General cognition and functional performance sufficiently preserved such that a diagnosis of dementia cannot be made by physician at the time of the baseline visit (MCI)
- •- General cognition and functional performance fulfilling a diagnosis of dementia at the time of the baseline visit (Dementia group)
- •- Fluent in Swedish
- •- Agrees to at least one lumbar puncture, MRI scan of the brain and neuropsychological testing.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 900
排除标准
- •Exclusion Criteria:
- •- Major depression as described in DSM-IV.
- •- History of schizophrenia or other recurrent psychotic disorder
- •- History of alcohol or substance abuse or dependence within the past 5 years
- •- Diseases that will make study participation difficult, such as terminal cancer or significant heart failure.
- •- Certain neurologic diseases, such as Huntington's disease, normal pressure hydrocephalus, brain tumor, subdural hematoma, multiple sclerosis, or persistent neurologic deficits or known structural brain abnormalities.
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