NCT02214862已完成早期 1 期
Pilot, Exploratory Study With [F18]-FDDNP-PET for in Vivo Diagnose of Tauopathy in Unclassified Parkinsonism
Fundacion Clinic per a la Recerca Biomédica1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2013年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To assess the Relative Volume of Distribution of [18F]-FDDNP in individuals with unclassifiable parkinsonism, and to try to correlate their eventual clinical diagnosis with baseline PET findings.
研究概览
简要总结
The PET tracer [F18]-FDDNP has a specific affinity for lesions containing tau protein.
The study consists of two phases:
- In the first (cross-sectional) phase it will be assessed the uptake of [18F]-FDDNP in 10 cases with progressive supranuclear palsy (PSP, a tauopathy) en 10 with multi-system atrophy (MSA, a non-tauopathy), along with 20 individuals with Unclassifiable Parkinsonism, as previously defined in a European cohort study.
- In the second (longitudinal) phase it will be prospectively followed the 20 unclassifiable patients (at 6, 12 and 18 months) by means of validated scales and accepted diagnostic criteria in order to try to correlate their eventual clinical diagnosis with baseline PET findings. On this basis, we endeavour to estimate the ability of this technique to detect in vivo underlying tau pathology in subjects initially unclassifiable on clinical grounds.
We hypothesized that:
- Patients with clinically definite PSP will present an increased uptake in basal ganglia, brainstem and cerebellum.
- Patients with clinically defined MSA will not present specific uptake.
- Part of unclassifiable patients with parkinsonism will present a pattern of uptake similar to patients with clinically defined PSP and this part along the clinical follow-up will be meet clinical criteria for diagnose of PSP
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is male or female ≥ 40 years old;
- •The individual has one of these three conditions:
- •probable PSP according to criteria of the National Institute of Neurological Disorders and Stroke (NINDS)
- •probable MSA according to criteria of the Second consensus statement on the diagnosis of multiple system atrophy
- •unclassifiable parkinsonism according to criteria defined by Katzenschlager et al, 2003:
- •Patients with atypical parkinsonism without response to treatment with levodopa and does not meet any of the diagnostic criteria for other known atypical parkinsonism
- •Patient given written consent
排除标准
- •The subject is diagnosed with Parkinson's Disease and meets the diagnostic criteria United Kingdom Parkinson's Disease Society Brain Bank -The subject is pregnant or breastfeeding;
- •The subject has a history of drug abuse or alcohol;
- •The subject has a moderate or severe renal function impairment (creatinine serum> 1.5 mg / dL);
- •The subject has a moderate or severe hepatic impairment (bilirubin> 2 times the upper limit of normal, transaminases> 3 times the limit top of normal);
- •The subject presents structural abnormalities in the basal ganglia or cortical level on MRI or CT;
- •The subject has participated in a clinical study with a pharmaceutical product investigation within 30 days prior to screening and / or a radiopharmaceutical minimum period of 5 radioactive half-lives prior to screening;
- •Occupational exposure to radiation> 15 milliSievert (mSv) / year
- •Use of nonsteroidal antiinflammatory drug (NSAIDs), for some reason, can not be replaced by any other drug 4 weeks before the PET scan;
- •The subject has allergy investigational product or any of its components;
- •The subject has a clinically severe active disease, with a hope reduced life;
- •The subject is claustrophobic / a.
研究组 & 干预措施
[F18]-FDDNP
Experimental
2-(1-{6-[(2-[F-18]fluoroethyl) (methyl)amino]-2-naphthyl} ethylidene) malononitrile Radiopharmaceutical tracer, intravenous, single dose of 360+/-20 megabecquerel
干预措施: [F18]-FDDNP (Drug)
结局指标
主要结局
To assess the Relative Volume of Distribution of [18F]-FDDNP in individuals with unclassifiable parkinsonism, and to try to correlate their eventual clinical diagnosis with baseline PET findings.
时间窗: 18 months
次要结局
- to assess the uptake of [18F]-FDDNP in cases clinically defined of progressive supranuclear palsy and multi-system atrophy(Baseline assessment)
- To assess the ability to detect in vivo underlying tau pathology in unclassifiable parkinsonism by means of PET -[18F]-FDDNP.(18 months)
研究者
Maria Jose Martí
MD, PhD
Fundacion Clinic per a la Recerca Biomédica
研究点 (1)
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