Prognostic Value of FP-CIT-SPECT in Patients With Parkinson´s Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Correlation between striatal FP-CIT uptake (measured in the years 2003 - 2006) versus the then (time 1) and the actual (time 2) motor and cognitive functions.
研究概览
简要总结
The investigators aim to study whether the nuclear medicine method FP-CIT-SPECT (more details see below) allows to predict the further clinical course of Parkinson´s disease. Especially the investigators are interested in the motor and cognitive functions of the parkinsonian patients.
详细描述
Background of this study:
Parkinson´s disease (PD) is a degenerative disorder of the nervous system. In PD, mainly the presynaptic dopaminergic neurons are affected: The dopamine synthesis as well as the active transport of dopamine into the synaptic gap by presynaptic dopamine transporters (DAT) is reduced. First parkinsonian symptoms occur when the concentration of dopamine within the basal ganglia is reduced by at least 80 per cent (Bernheimer et al. 1973). The reduced DAT density represents a typical phenomenon of PD. The DAT density can be measured by means of nuclear medicine methods: the tracer FP-CIT (Fluoropropyl-Carbomethoxy-Iodophenyl-Tropane) has a high affinity to presynaptic DAT (Booij et al. 1998). PD patients show a significantly lower striatal FP-CIT uptake than healthy controls. Therefore FP-CIT SPECT supports the diagnosis of PD (Benamer et al. 2000).
Aims of this study:
To test the predictive value of FP-CIT-SPECT concerning the clinical course of PD.
Study protocol:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Parkinson´s disease according to the Queen Square Brain Bank criteria (Hughes et al. 1992).
- •FP-CIT-SPECT at the Department of Nuclear Medicine, Saarland University, in the years between 2003 -
- •Informed consent.
排除标准
- •Severe neurological (except Parkinson´s disease), psychiatric or internal diseases after the FP-CIT-SPECT.
- •Patients with a history of drug or alcohol abuse.
- •Patients with dementia (Mini-Mental-State-Test < 24 points).
- •Psychosis or antipsychotic treatment in the last 12 months.
- •Patients with pallidotomy or deep brain stimulation.
结局指标
主要结局
Correlation between striatal FP-CIT uptake (measured in the years 2003 - 2006) versus the then (time 1) and the actual (time 2) motor and cognitive functions.
时间窗: Between 4 and 7 years after FP-CIT-SPECT
次要结局
未报告次要终点
研究者
Joerg Spiegel
Assistant medical director
Universität des Saarlandes