Prediction of Dementia in Parkinson's Disease by Measuring Cerebral Metabolism With PET Scan

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prediction of Dementia in Parkinson's Disease by Measuring Cerebral Metabolism With PET Scan

Conditions
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Parkinson Disease

Intervention / Treatment
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* Other: Explorations


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria 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 Exclusion Criteria 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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Parkinson disease<br>Patients with a Parkinson disease with clinical diagnosis made for at least 5 years | Other: Explorations<br>* Imaging tests and neuropsychological assessment are carried out within 60 days following patient enrollment. Neuropsychological assessment lasts 1:30 to 2:00 hours and is conducted by a psychologist in an interview during which patient will pass several tests on memory, language, attention or orientation in space. These tests do not require discontinuation of Parkinson's disease treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset of dementia authenticated by a neuropsychological assessment (MDS Task Force criteria) |  | Year 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dementia, Cerebral metabolism, PET scan