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

NCT02855021 | Unknown

• 1 other identifier: P140306
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Dementia; Cerebral metabolism; PET scan

Outcome Measures

Primary Outcomes (1)

• Onset of dementia authenticated by a neuropsychological assessment (MDS Task Force criteria)

  Year 2

Secondary Outcomes (8)

• 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

Study Arms (1)

Parkinson disease

OTHER

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

Other: Explorations

Interventions

Explorations OTHER

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.

Parkinson disease

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female with Parkinson's Disease
• \< 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Henri Mondor Hospital

Créteil, 94010, France

Location

MeSH Terms

Conditions

Parkinson Disease; Dementia

Interventions

Space Flight

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Aviation; Transportation; Technology, Industry, and Agriculture

Study Officials

• Claire THIRIEZ, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claire THIRIEZ, MD

CONTACT

(0)1 49 81 43 12; claire.thiriez@aphp.fr

Philippe REMY, MD, PhD

CONTACT

(0)1 49 81 23 03; neuro-philippe.remy@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2016
• First Posted: August 4, 2016
• Study Start: September 1, 2016
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: August 4, 2016

Record last verified: 2016-07

Locations

FR (1)