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

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.

Study Overview

• Status: Unknown
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: Explorations

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 Type: Interventional
• Enrollment (Anticipated): 138
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Claire THIRIEZ, MD; Phone Number: +33 (0)1 49 81 43 12; Email: claire.thiriez@aphp.fr
• Study Contact Backup: Name: Philippe REMY, MD, PhD; Phone Number: +33 (0)1 49 81 23 03; Email: neuro-philippe.remy@aphp.fr

Study Locations

• France
  • Creteil, France, 94010
    • Henri Mondor Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Parkinson disease; Patients with a Parkinson disease with clinical diagnosis made for at least 5 years

Other: Explorations; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Claire THIRIEZ, MD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): September 1, 2019

Study Registration Dates

• First Submitted: June 27, 2016
• First Submitted That Met QC Criteria: July 31, 2016
• First Posted (Estimate): August 4, 2016

Study Record Updates

• Last Update Posted (Estimate): August 4, 2016
• Last Update Submitted That Met QC Criteria: July 31, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: PET scan; Dementia; Cerebral metabolism
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Dementia
• Other Study ID Numbers: P140306

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED