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

Parkinson Disease Clinical Trial

— PREDEMPARK  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02855021
• Other study ID #: P140306
• Status: Not yet recruiting
• Phase: N/A
• First received: June 27, 2016
• Last updated: July 31, 2016
• Start date: September 2016
• Est. completion date: September 2019

Study information

• Verified date: July 2016
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Claire THIRIEZ, MD
• Phone: (0)1 49 81 43 12
• Email: claire.thiriez[@]aphp.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 138
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Dementia
• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
France	Henri Mondor Hospital	Creteil

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Onset of dementia authenticated by a neuropsychological assessment (MDS Task Force criteria)		Year 2	No
Secondary	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	No
Secondary	Determination of cerebral blood flow (CBF) by arterial spin labelling (ASL) perfusion 3Tesla (3T) Magnetic Resonance Imaging (MRI)		Day 90	No
Secondary	Identifying different striatal functional connectivity patterns by resting state functional MRI at 3T		Day 90	No
Secondary	Cerebral cortex trophicity by VBM technique (Voxel-based morphometry)		Day 90	No
Secondary	Number of hyperintensities in the FLAIR MR image		Day 90	No
Secondary	Concentration of iron in the mesencephalon measured with MRI		Day 90	No
Secondary	Degree of anosmia measured with the University of Pennsylvania Smell Identification Test (UPSIT)		Day 90	No
Secondary	Correlation between initial clinical, neuropsychological and biological parameters and risk of onset of dementia		Day 0 and year 2	No