Quantification of Cerebral Cholinergic Function in Patients With Parkinson´s Disease by Means of Nuclear Medicine Methods
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 of density of acetylcholine receptors in distinct brain areas versus the clinical parameters resting tremor, postural tremor, hypokinesia and rigidity in patients with Parkinson´s disease
研究概览
简要总结
Parkinson´s disease is based on a Lewy body degeneration of cerebral and extracerebral neurons. This Lewy body degeneration includes cerebral cholinergic neurons besides dopaminergic neurons.
In previous studies the investigators found that some clinical parkinsonian symptoms - primarily hypokinesia and rigidity - significantly correlate with the dopaminergic nigrostriatal degeneration which was quantified by dopamine transporter imaging. In contrast to that, resting or postural parkinsonian tremor does not correlate with the dopaminergic nigrostriatal degeneration. Obviously further cerebral changes - for instance possible changes / degeneration of cerebral cholinergic neurons - contribute to parkinsonian tremor.
In this study the investigators apply cerebral 5-IA-85380-SPECT to quantify the local density of cerebral nicotinergic cholinergic receptors in patients with Parkinson´s disease. The investigators will correlate the results of cerebral 5-IA-85380-SPECT with the clinical parkinsonian main symptoms hypokinesia, rigidity and primarily resting and postural tremor. In particular, it is of interest whether changes of cerebral cholinergic neurons are involved in the generation of parkinsonian tremor.
详细描述
The protocol of our study - as explained in the following - was approved by the Local Ethics committee (Ethics committee of the medical association of the Saarland, D-66111 Saarbrücken, Germany, file number 201/06) and by the German Federal Agency for Radiation Protection (Bundesamt für Strahlenschutz, D-38201 Salzgitter, Germany, file number Z 5 - 22461/2 2008-207).
Aims of this study:
In this study we measure the density and local distribution of cerebral acetylcholine receptors in patients with Parkinson´s disease (PD) by means of [123I]5-IA-85380 SPECT. [123I]5-IA-85380 SPECT was applied in healthy volunteers (Fujita et al. 2002, Fujita et al. 2003, Ding et al. 2004, Mamede et al. 2004, Obrzut et al. 2005) and PD patients (Fukuyama et al. 2004, Bucerius et al. 2006, Fujita et al. 2006). These numerous previous studies proved that [123I]5-IA-85380 SPECT is a safe and effective method to visualize cerebral acetylcholine receptors.
We intend to correlate the density and distribution of cerebral acetylcholine receptors with the clinical parkinsonian cardinal symptoms tremor, hypokinesia and rigidity. The patients are out-patients who are treated by the Department of Neurology, Saarland University, D-66421 Homburg/Saar, Germany. The nuclear medicine measurement [123I]5-IA-85380 SPECT will be performed in the Department of Nuclear medicine of the University of Würzburg, D-97080 Würzburg, Germany.
This study should answer the following questions:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with Parkinson´s disease (after the UK Brain Bank criteria)
- •Hoehn and Yahr stage 1
- •age 50 - 75 years
- •non-smokers
- •informed consent to participate in the study
排除标准
- •pregnant or nursing women
- •no adequate contraception in women who are capable of childbearing
- •male patients living with fertile women without adequate contraception
- •actual or past drug or alcohol abuse
- •dementia (minimental state test < 25 points)
- •psychosis or antipsychotic medication in the last 12 months
- •cholinergic or anticholinergic medication
- •unstable or severe internal diseases
结局指标
主要结局
Correlation of density of acetylcholine receptors in distinct brain areas versus the clinical parameters resting tremor, postural tremor, hypokinesia and rigidity in patients with Parkinson´s disease
时间窗: 1 time
次要结局
未报告次要终点
研究者
Joerg Spiegel
M.D
Universität des Saarlandes