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

NCT ID: NCT02855021

Last Updated: 2016-08-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2019-09-30

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Parkinson disease

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

Group Type: OTHER

Explorations

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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

• 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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claire THIRIEZ, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Henri Mondor Hospital

Créteil, , France

Countries

France

Central Contacts

Claire THIRIEZ, MD

Role: CONTACT

claire.thiriez@aphp.fr

(0)1 49 81 43 12 ext. +33

Philippe REMY, MD, PhD

Role: CONTACT

neuro-philippe.remy@aphp.fr

(0)1 49 81 23 03 ext. +33

Other Identifiers

P140306

Identifier Type: -

Identifier Source: org_study_id