Optimization of Morphomer-based Alpha-synuclein PET Tracers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Detection of alpha-synuclein pathology
研究概览
简要总结
The aim of the project is to develop the first alpha-synuclein (a-syn)-specific PET tracer. The research phase will exploit ACI's proprietary MorphomerTM library and extensively optimized screening workflow.
Promising PET-tracer candidates will be tested for their ability in detecting a-syn pathology in patients with a range of Parkinsonian conditions with different a-syn levels and distributions, comprising hereditary forms of PD and other synucleinopathies.
详细描述
Aims:
Today there is no way of detecting a-synuclein pathology in life, and thus the diagnoses of Parkinson's Disease (PD) and the closely related synucleinopathies Dementia with Lewy Bodies (DLB) and Multiple system atrophy (MSA) are clinical diagnoses, that can be supported by dopamine (F-DOPA) imaging and biomarkers (f.ex cerebrospinal fluid neurofilament light chain), but where the ultimate diagnosis is not certain until at post mortem investigation of the brain.
The general aim of this study is to assess a newly developed positron emission tomography (PET) tracers for a-synuclein and to study the ability of the tracer in detecting the underlying pathology in PD, DLB and MSA. If the PET tracers can detect the pathology reliably our hope is that this tracers can assist in future clinical trials for PD, DLB and MSA.
Primary aim
• to assess the brain a-synuclein load in vivo using [18F]ACI-3847 PET in MSA, DLB and Parkinson's disease
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 50-100 years.
- •Fulfill the criteria for PD, DLB, MSA, PSP or CBS. Alongside with these participants patients with duplications in the gene coding for a-synuclein will be included.
- •Absence of cognitive symptoms or parkinsonism as assessed by a physician with special interest in cognitive disorders (Healthy controls).
- •Speaks and understands Swedish to the extent that an interpreter was not necessary for the patient to fully understand the study information and cognitive tests.
排除标准
- •Significant unstable systemic illness or organ failure, such as terminal cancer, that makes it difficult to participate in the study.
- •Current significant alcohol or substance misuse.
- •Refusing MRI or PET.
结局指标
主要结局
Detection of alpha-synuclein pathology
时间窗: July 2020 - August 2022
Assess the ability of alpha-synuclein tau tracer \[18F\]-ACI3847 in detecting tau pathology in synucleinopathies.
次要结局
未报告次要终点
研究者
Oskar Hansson
Professor
Skane University Hospital