Synapsing Retrospective Biomarker Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 1,799
- 试验地点
- 1
- 主要终点
- Concentration of biomarkers in blood
研究概览
简要总结
This is a retrospective observational study to evaluate the clinical utility of blood-based biomarkers in the diagnosis and management of patients with a neurodegenerative disease (ND) or mental disorder (MD).
详细描述
This study will collect clinical and biomarker data from patients and controls to identify a) a blood-based diagnostic biomarker for mental disorders, and b) a blood-based biomarker that could be used as a surrogate end-point for the principal neuropsychiatric symptoms.
Specific research questions are:
Can blood-based biomarkers provide a faster more objective diagnosis for major depressive disorder, bipolar disorders or schizophrenia? Can the same biomarkers also aid in the differential diagnosis from neurodegenerative diseases? Do blood-based synaptic biomarkers correlate with structural and functional brain changes, cognitive performance and psychiatric symptoms in patients with major depressive disorder, bipolar disorders, schizophrenia, Alzheimer's disease, dementia with Lewy bodies, frontotemporal dementia or Parkinson's disease? Can the blood-based synaptic biomarkers predict therapeutic response in patients with major depressive disorder, bipolar disorders or schizophrenia?
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age>18 and donation of blood,
- •full clinical and psychological assessment
- •Available neuroimaging is optional as not all patients are suitable.
- •Age and sex-matched unaffected volunteers without a MD or ND diagnosis are used as controls.
- •Unaffected controls are usually spouses or children of patients that are informed about our studies at each clinical site.
排除标准
- •Lack of neuropsychological data,
- •anticoagulant treatment such as acenocoumarol, heparin, warfarin, dabigatran, rivaroxaban, apixaban, drug abuse in the last year,
- •medical history of cancer affecting the central nervous system that has not been in complete remission for 5 years or longer,
- •the patient has received potentially neurotoxic chemotherapy and/or patient has received cranial radiotherapy.
- •Clinical diagnosis of Alzheimer's disease where pathophysiological markers (measured in CSF or plasma) are inconsistent with Alzheimer's disease pathophysiology.
- •Cognitively healthy volunteers where pathophysiological markers (measured in CSF or plasma) are consistent with Alzheimer's disease or other neurodegenerative pathophysiology.
研究组 & 干预措施
Schizophrenia
Clinical diagnosis of schizophrenia
Parkinson's disease
Clinical diagnosis of Parkinson's disease
Alzheimer's disease
Clinical diagnosis of Alzheimer's disease
Dementia with Lewy bodies
Clinical diagnosis of dementia with Lewy bodies
Unaffected controls
No clinical diagnosis of a primary psychiatric disorder or neurodegenerative disease
Frontotemporal dementia
Clinical diagnosis of frontotemporal dementia
Major depressive disorder
Clinical diagnosis of major depressive disorder
Bipolar disorder
Clinical diagnosis of type I + II Bipolar disorder
结局指标
主要结局
Concentration of biomarkers in blood
时间窗: through study completion, an average of 1 year
Concentration of biomarker (eg., NPTX2) in blood measured by immunoassay or mass spectrometry-based techniques.
Diagnosis
时间窗: Baseline
Primary diagnosis following evaluation by clinician and neuropsychologist
Boston Naming Test
时间窗: Up to 3-months
Total score on the Boston Naming Test. Range 0-60. Higher scores represent better outcomes.
次要结局
- Structural brain changes(Up to 3-months)
研究者
Olivia E Belbin, PhD
Dr
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau