- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00598390
PET Imaging of Cannabinoid CB1 Receptors Using [11C]MePPEP
PET Test/Retest Brain Imaging of Cannabinoid CB1 Receptors Using [11C]MePPEP
Studieoversigt
Detaljeret beskrivelse
MePPEP is a ligand that is highly selective for the cannabinoid type 1 (CB1) receptor. This receptor is considered the most common G-coupled protein receptor in the brain (Pacher et al., 2006). The CB1 receptor is the site of action of Delta-9-tetrahydrocannbinol (THC), the active compound in marijuana, and is found primarily on the presynaptic terminals of dopaminergic, glutamatergic, GABAergic neurons (Howlett et al., 2002). The function of the CB1 receptor is not entirely clear; however, it has been implicated in several neurological and psychiatric disorders, and a selective inverse agonist, rimonabant, is currently in use in Europe for the treatment of obesity (Van Gaal et al., 2005). [11C]MePPEP was developed to enhance our understanding of the in vivo characteristics of the CB1 receptor (e.g., receptor density and receptor occupancy with pharmaceuticals).
The purpose of this protocol is to establish an accurate method to measure CB1 receptor levels in brain by performing test/retest brain imaging studies. The results of this overall study are required to apply this PET ligand in various neurological and psychiatric disorders in the future.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
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Maryland
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Bethesda, Maryland, Forenede Stater, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
- INCLUSION CRITERIA:
<TAB>
All subjects must be healthy and aged 18 65 years, with history/physical exam, ECG, and laboratory tests within one year of the PET scan. The volunteer must sign an informed consent form.
EXCLUSION CRITERIA:
- Current psychiatric illness, substance abuse including marijuana use, or severe systemic disease based on history and physical exam.
- Laboratory tests with clinically significant abnormalities or positive urine toxicology screen.
- Prior participation in other research protocols in the last year such that radiation exposure would exceed the annual limits.
- Pregnancy and breast feeding.
- Claustrophobia.
- Presence of ferromagnetic metal in the body or heart pacemaker.
- Positive HIV test.
- Employee of the investigative site or an immediate family member of an employee of the investigative site. Immediate family member is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
- Employee of Eli Lilly and Company.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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Reproducibility of novel PET tracer for CB1 in brain imaging.
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Sekundære resultatmål
Resultatmål |
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Fordeling og varians af CB1-receptorer i hjernen hos raske kontroller.
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Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Generelle publikationer
- Abi-Dargham A, Gandelman M, Zoghbi SS, Laruelle M, Baldwin RM, Randall P, Zea-Ponce Y, Charney DS, Hoffer PB, Innis RB. Reproducibility of SPECT measurement of benzodiazepine receptors in human brain with iodine-123-iomazenil. J Nucl Med. 1995 Feb;36(2):167-75.
- Burger C, Buck A. Requirements and implementation of a flexible kinetic modeling tool. J Nucl Med. 1997 Nov;38(11):1818-23.
- Carson RE, Huang SC, Green MV. Weighted integration method for local cerebral blood flow measurements with positron emission tomography. J Cereb Blood Flow Metab. 1986 Apr;6(2):245-58. doi: 10.1038/jcbfm.1986.38.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 080048
- 08-M-0048
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 .
Kliniske forsøg med [11C]MePPEP
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National Institute of Mental Health (NIMH)National Institute of Mental Health, Eli Lilly & Co.AfsluttetSund og raskForenede Stater
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Columbia UniversityRekrutteringNeurodegenerative sygdomme | Amyotrofisk lateral sklerose | Alzheimers sygdomForenede Stater
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Wendell Yap, MDUniversity of Kansas Medical CenterIkke længere tilgængeligProstatakræftForenede Stater
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Hoffmann-La RocheAfsluttetAlzheimers sygdom, sund frivilligForenede Stater
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Columbia UniversityAfsluttet
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Yale UniversityNational Center for Complementary and Integrative Health (NCCIH)RekrutteringOpførsel, sundhedForenede Stater
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Mayo ClinicNational Institute of Neurological Disorders and Stroke (NINDS)Rekruttering
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CHDI Foundation, Inc.Universitaire Ziekenhuizen KU LeuvenAfsluttet
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Columbia UniversityNational Institute on Aging (NIA)RekrutteringAlzheimers sygdomForenede Stater
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National Institute of Mental Health (NIMH)Afsluttet