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

31. juli 2016 opdateret af: Assistance Publique - Hôpitaux de Paris

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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

138

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Frankrig
      • Creteil, Frankrig, 94010
        • Henri Mondor Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

45 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Parkinson disease
Patients with a Parkinson disease with clinical diagnosis made for at least 5 years
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Onset of dementia authenticated by a neuropsychological assessment (MDS Task Force criteria)
Tidsramme: Year 2
Year 2

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Assistance Publique - Hôpitaux de Paris

Efterforskere

  • Ledende efterforsker: Claire THIRIEZ, MD, Assistance Publique - Hôpitaux de Paris

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2016

Primær færdiggørelse (Forventet)

1. september 2019

Studieafslutning (Forventet)

1. september 2019

Datoer for studieregistrering

Først indsendt

27. juni 2016

Først indsendt, der opfyldte QC-kriterier

31. juli 2016

Først opslået (Skøn)

4. august 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

4. august 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. juli 2016

Sidst verificeret

1. juli 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • P140306

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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