Clinical trial NCT02855021: Prediction of Dementia in Parkinson's Disease by Measuring Cerebral Metabolism With PET Scan
Official title: Prediction of Dementia in Parkinson's Disease by Measuring Cerebral Metabolism With PET Scan
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: Dementia
Cerebral metabolism
PET scan
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2016-08-04
Enrollment: 138
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Onset of dementia authenticated by a neuropsychological assessment (MDS Task Force criteria)
timeFrame: Year 2
Secondary outcomes:
measure: 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
timeFrame: Day 90
measure: Determination of cerebral blood flow (CBF) by arterial spin labelling (ASL) perfusion 3Tesla (3T) Magnetic Resonance Imaging (MRI)
timeFrame: Day 90
measure: Identifying different striatal functional connectivity patterns by resting state functional MRI at 3T
timeFrame: Day 90
measure: Cerebral cortex trophicity by VBM technique (Voxel-based morphometry)
timeFrame: Day 90
measure: Number of hyperintensities in the FLAIR MR image
timeFrame: Day 90
measure: Concentration of iron in the mesencephalon measured with MRI
timeFrame: Day 90
measure: Degree of anosmia measured with the University of Pennsylvania Smell Identification Test (UPSIT)
timeFrame: Day 90
measure: Correlation between initial clinical, neuropsychological and biological parameters and risk of onset of dementia
timeFrame: Day 0 and year 2
Other outcomes:
Locations:
city: Creteil
country: France
facility: Henri Mondor Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Claire THIRIEZ, MD
role: PRINCIPAL_INVESTIGATOR
References: