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

Not Applicable

• Conditions: Parkinson Disease
• Interventions: Other: Explorations

• Registration Number: NCT02855021
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2016-06-27
• Status Verified: 2016-07
• Study First Submitted QC: 2016-07-31
• Last Update Submitted: 2016-07-31
• Study First Posted: 2016-08-04
• Last Update Posted: 2016-08-04
• Study Start: 2016-09
• Primary Completion: 2019-09
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Parkinson disease	Explorations	Patients with a Parkinson disease with clinical diagnosis made for at least 5 years

Primary Outcome Measures

Name	Time	Method
Onset of dementia authenticated by a neuropsychological assessment (MDS Task Force criteria)	Year 2

Secondary Outcome Measures

Name	Time	Method
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
Identifying different striatal functional connectivity patterns by resting state functional MRI at 3T	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

Trial Locations

Locations (1)

Henri Mondor Hospital; 🇫🇷 Creteil, France