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

Primary Purpose

Parkinson Disease

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Explorations
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Parkinson Disease focused on measuring Dementia, Cerebral metabolism, PET scan

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Henri Mondor Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Parkinson disease

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Determination of cerebral blood flow (CBF) by arterial spin labelling (ASL) perfusion 3Tesla (3T) Magnetic Resonance Imaging (MRI)
Identifying different striatal functional connectivity patterns by resting state functional MRI at 3T
Cerebral cortex trophicity by VBM technique (Voxel-based morphometry)
Number of hyperintensities in the FLAIR MR image
Concentration of iron in the mesencephalon measured with MRI
Degree of anosmia measured with the University of Pennsylvania Smell Identification Test (UPSIT)
Correlation between initial clinical, neuropsychological and biological parameters and risk of onset of dementia

Full Information

First Posted
June 27, 2016
Last Updated
July 31, 2016
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02855021
Brief Title
Prediction of Dementia in Parkinson's Disease by Measuring Cerebral Metabolism With PET Scan
Acronym
PREDEMPARK
Official Title
Prediction of Dementia in Parkinson's Disease by Measuring Cerebral Metabolism With PET Scan
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Dementia, Cerebral metabolism, PET scan

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
138 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Parkinson disease
Arm Type
Other
Arm Description
Patients with a Parkinson disease with clinical diagnosis made for at least 5 years
Intervention Type
Other
Intervention Name(s)
Explorations
Intervention Description
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.
Primary Outcome Measure Information:
Title
Onset of dementia authenticated by a neuropsychological assessment (MDS Task Force criteria)
Time Frame
Year 2
Secondary Outcome Measure Information:
Title
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
Time Frame
Day 90
Title
Determination of cerebral blood flow (CBF) by arterial spin labelling (ASL) perfusion 3Tesla (3T) Magnetic Resonance Imaging (MRI)
Time Frame
Day 90
Title
Identifying different striatal functional connectivity patterns by resting state functional MRI at 3T
Time Frame
Day 90
Title
Cerebral cortex trophicity by VBM technique (Voxel-based morphometry)
Time Frame
Day 90
Title
Number of hyperintensities in the FLAIR MR image
Time Frame
Day 90
Title
Concentration of iron in the mesencephalon measured with MRI
Time Frame
Day 90
Title
Degree of anosmia measured with the University of Pennsylvania Smell Identification Test (UPSIT)
Time Frame
Day 90
Title
Correlation between initial clinical, neuropsychological and biological parameters and risk of onset of dementia
Time Frame
Day 0 and year 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claire THIRIEZ, MD
Phone
(0)1 49 81 43 12
Ext
+33
Email
claire.thiriez@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe REMY, MD, PhD
Phone
(0)1 49 81 23 03
Ext
+33
Email
neuro-philippe.remy@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claire THIRIEZ, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henri Mondor Hospital
City
Creteil
ZIP/Postal Code
94010
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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