Prediction of Dementia in Parkinson's Disease by Measuring Cerebral Metabolism With PET Scan
试验速览
- 阶段
- 不适用
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Onset of dementia authenticated by a neuropsychological assessment (MDS Task Force criteria)
研究概览
简要总结
Parkinson's disease (PD) is a common disease. Dementia will affect 80% of these patients during their evolution. In addition, treatments of motor signs have a potential impact on these disorders and conversely.
The purpose of this study is to show focal abnormalities in brain metabolism in the precuneus and posterior cingulate region are predictive of the onset of dementia within 2 years.
详细描述
Cognitive impairment and dementia have become major factors of disability induced by Parkinson's disease. The prediction of dementia in any given patient may be useful for prognosis but also for discussion of setting up heavy therapeutic techniques, especially surgical. Currently, known predictors are disease severity, age and existence of pre-cognitive disorders; other assumptions are discussed. Among these, morphological imaging techniques (MRI) and functional techniques (MRI, PET) are proposed.
Use increasingly early of heavy, expensive and potentially ineffective surgical treatment in dementia makes it necessary to find independent, early and reliable markers of the onset of dementia in Parkinson's Disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female with Parkinson's Disease
- •45 < Age ≥ 75 years
- •Parkinson's disease with clinical diagnosis made for at least 5 years (60 months)
- •Patient able to perform cognitive tests in French during 1 hour 30 minutes
- •Patient having provided a signed consent to participate in this trial
- •Be either affiliated to, or a beneficiary of, a social security category
- •Existence of caregiver at least contactable by phone
排除标准
- •Parkinson's disease diagnosed before 40 years old
- •Clinical evidence for dementia or dementia criteria according to level 1 MDS-Task Force (Dubois et al. 2007)
- •Atypical form of parkinsonism
- •Other disease affecting the central nervous system
- •Poorly controlled diabetes with glucose > 2.0 g/l or HbA1c>7,5% based on results of less than 3 months
- •Taking a cholinesterase inhibitor treatment, memantine or long-term benzodiazepines other than referred hypnotic, neuroleptic
- •History of surgery for Parkinson's disease or planned surgery within 6 months. Surgery is possible beyond
- •Cons-indication to 3T MRI
- •Inability to lie down for 60 minutes
- •Legal protection
- •Patient living outside the Ile-de France region
- •Secondary exclusion criteria
- •Pregnant, breastfeeding or non-menopausal woman not taking contraception in the first 2 months of the study
- •Existence of a significant brain injury on MRI
- •Neuropsychological assessment at baseline showing dementia
- •Fasting glucose > 1.6 g/l the day of FDG-PET
研究组 & 干预措施
Parkinson disease
Patients with a Parkinson disease with clinical diagnosis made for at least 5 years
干预措施: Explorations (Other)
结局指标
主要结局
Onset of dementia authenticated by a neuropsychological assessment (MDS Task Force criteria)
时间窗: Year 2
次要结局
- Identifying different striatal functional connectivity patterns by resting state functional MRI at 3T(Day 90)
- Cerebral cortex trophicity by VBM technique (Voxel-based morphometry)(Day 90)
- Number of hyperintensities in the FLAIR MR image(Day 90)
- Concentration of iron in the mesencephalon measured with MRI(Day 90)
- Degree of anosmia measured with the University of Pennsylvania Smell Identification Test (UPSIT)(Day 90)
- Correlation between initial clinical, neuropsychological and biological parameters and risk of onset of dementia(Day 0 and year 2)
- Regional cerebral glucose consumption in the parietal lobes studied with fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) and regional glucose consumption in the caudate nucleus and prefrontal areas studied with FDG PET(Day 90)
- Determination of cerebral blood flow (CBF) by arterial spin labelling (ASL) perfusion 3Tesla (3T) Magnetic Resonance Imaging (MRI)(Day 90)