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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02855021
Acronym
PREDEMPARK
Enrollment
138
Registered
2016-08-04
Start date
2016-09-30
Completion date
2019-09-30
Last updated
2016-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

Dementia, Cerebral metabolism, PET scan

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.

Interventions

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.

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Onset of dementia authenticated by a neuropsychological assessment (MDS Task Force criteria)Year 2

Secondary

MeasureTime frame
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 3TDay 90
Cerebral cortex trophicity by VBM technique (Voxel-based morphometry)Day 90
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 PETDay 90
Concentration of iron in the mesencephalon measured with MRIDay 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 dementiaDay 0 and year 2
Number of hyperintensities in the FLAIR MR imageDay 90

Countries

France

Contacts

Primary ContactClaire THIRIEZ, MD
claire.thiriez@aphp.fr(0)1 49 81 43 12
Backup ContactPhilippe REMY, MD, PhD
neuro-philippe.remy@aphp.fr(0)1 49 81 23 03

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026