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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02855021
Recruitment Status : Unknown
Verified July 2016 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Not yet recruiting
First Posted : August 4, 2016
Last Update Posted : August 4, 2016
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment Phase
Parkinson Disease Other: Explorations Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 138 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prediction of Dementia in Parkinson's Disease by Measuring Cerebral Metabolism With PET Scan
Study Start Date : September 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.





Primary Outcome Measures :
  1. Onset of dementia authenticated by a neuropsychological assessment (MDS Task Force criteria) [ Time Frame: Year 2 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Determination of cerebral blood flow (CBF) by arterial spin labelling (ASL) perfusion 3Tesla (3T) Magnetic Resonance Imaging (MRI) [ Time Frame: Day 90 ]
  3. Identifying different striatal functional connectivity patterns by resting state functional MRI at 3T [ Time Frame: Day 90 ]
  4. Cerebral cortex trophicity by VBM technique (Voxel-based morphometry) [ Time Frame: Day 90 ]
  5. Number of hyperintensities in the FLAIR MR image [ Time Frame: Day 90 ]
  6. Concentration of iron in the mesencephalon measured with MRI [ Time Frame: Day 90 ]
  7. Degree of anosmia measured with the University of Pennsylvania Smell Identification Test (UPSIT) [ Time Frame: Day 90 ]
  8. Correlation between initial clinical, neuropsychological and biological parameters and risk of onset of dementia [ Time Frame: Day 0 and year 2 ]


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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02855021


Contacts
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Contact: Claire THIRIEZ, MD (0)1 49 81 43 12 ext +33 claire.thiriez@aphp.fr
Contact: Philippe REMY, MD, PhD (0)1 49 81 23 03 ext +33 neuro-philippe.remy@aphp.fr

Locations
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France
Henri Mondor Hospital
Creteil, France, 94010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Claire THIRIEZ, MD Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02855021    
Other Study ID Numbers: P140306
First Posted: August 4, 2016    Key Record Dates
Last Update Posted: August 4, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Dementia
Cerebral metabolism
PET scan
Additional relevant MeSH terms:
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Parkinson Disease
Dementia
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders