- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01904240
Evaluation of a Biomarker Related to the GI Tract for the Diagnosis of Parkinson's Disease
11. november 2014 oppdatert av: Rush University Medical Center
Lipopolysaccharide Binding Protein as a Potential Biomarker of Parkinson's Disease
The cause of Parkinson's disease (PD) is currently unknown.
Both environmental and genetic factors have been found to contribute to PD pathogenesis.
The pathology of PD is distributed throughout the entire nervous system including the central, peripheral, and enteric nervous system.
There is evidence that inflammation plays a major role in neurodegeneration in PD.
In both the striatum and substantia nigra of PD patients activated microglia were found and proinflammatory cytokines (TNF, IL-1B, IL-6, iNOS) are increased in the CSF.
An inflammation-driven animal model has emerged and has been widely accepted as a model of the disease based on lipopolysaccharide (LPS) induced neurotoxicity.
LPS is an endotoxin found on the outer membrane of gram negative bacteria and humans are exposed to LPS through the intestinal tract.
The intestinal tract and thus the enteric nervous system serve as a conduit to the central nervous system.
It has been posited that the inflammatory process could gain access to the lower brainstem via the vagal nerve and then ascend through the basal mid- and forebrain until it reaches the cerebral cortex, producing various pre-motor and motor symptoms of PD along the way.
LPS may be one of the inflammatory triggers involved in this process.
Systemic exposure to bacterial endotoxin can be determined by measuring plasma LPS binding protein (LBP).
A study of 9 patients with early PD (median Hoehn and Yahr stage 2) and age matched controls found that the PD subjects had a significantly lower mean level of plasma LBP compared to control subjects.
The aim of the research plan is to establish LBP as a potential biomarker for PD across a spectrum of disease severity.
Studieoversikt
Status
Fullført
Forhold
Studietype
Observasjonsmessig
Registrering (Faktiske)
200
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Illinois
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Chicago, Illinois, Forente stater, 60612
- Rush University Medical Center
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
30 år til 90 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Rush University Movement Disorders Clinic
Beskrivelse
Inclusion Criteria for Parkinson's disease subjects:
- Patients with a clinical diagnosis of Parkinson's disease by United Kingdom Parkinson Disease Society Brain Bank criteria will be recruited.
- Hoehn and Yahr stage 1-5
- Parkinson's disease symptomatic treatment will be allowed.
Exclusion Criteria for Parkinson's disease subjects:
- Treatment with medications that may induce parkinsonism (metoclopramide, typical, or atypical antipsychotic agents)
- Known diagnosis of inflammatory bowel disease.
- Symptomatic functional GI disease that significantly impairs intestinal mobility such as scleroderma or use of GI motility drugs.
- Acute illness requiring immediate hospitalization.
- Presence of short bowel syndrome or severe malnutrition with ideal body weight < or = 90%
Inclusion Criteria for control subjects:
- No evidence of GI symptoms other than minor hematochezia attributable to hemorrhoids.
- No evidence of symptoms of Parkinson's disease.
- Matching in age and gender to the Parkinson's disease patients.
Exclusion Criteria for control subjects:
- Presence of Parkinson's disease or its symptoms.
- Treatment with medications that may induce parkinsonism (metoclopramide, typical, or atypical antipsychotic agents)
- Known diagnosis of inflammatory bowel disease.
- Symptomatic functional GI disease that significantly impairs intestinal mobility such as scleroderma or use of GI motility drugs.
- Acute illness requiring immediate hospitalization.
- Presence of short bowel syndrome or severe malnutrition with ideal body weight < or = 90%
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Parkinson's disease patients
Patients with Parkinson's disease
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Subjects without Parkinson's disease
Control subjects without Parkinson's disease
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Lipopolysaccharide binding protein (LBP) level
Tidsramme: one day
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measure serum and plasma LBP levels in PD patients and control subjects
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one day
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Gian D Pal, MD, Rush University Medical Center
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juli 2013
Primær fullføring (Faktiske)
1. juni 2014
Studiet fullført (Faktiske)
1. juni 2014
Datoer for studieregistrering
Først innsendt
9. juli 2013
Først innsendt som oppfylte QC-kriteriene
17. juli 2013
Først lagt ut (Anslag)
22. juli 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
13. november 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. november 2014
Sist bekreftet
1. november 2014
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 12102401-IRB01
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .