- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00039702
Brain Imaging in Alzheimer's Disease
SPECT Imaging of Alpha4beta2 Nicotinic Acetylcholine Receptors Using [123I]5-I-A-85380 in Alzheimer's Disease
The purpose of this study is to use brain imaging technology to examine the role of certain brain chemicals in individuals with Alzheimer's disease (AD) and in healthy volunteers.
Cognitive dysfunction in people with AD is thought to arise from decreased chemical activity in specific parts of the brain. Decreases in alpha4beta2 nicotinic acetycholine receptors (nAChRs) have been found in the brains of people who died with AD; however, the status of this receptor system in living brains remains unclear. This study will use single photon emission computed tomography (SPECT) to study this receptor system in people with AD who have mild to moderate dementia and in healthy volunteers. In addition, this study will examine the relationship between cognitive dysfunction and nAChR deficits in the brains of individuals with AD.
Participants with AD will have four clinic visits; healthy volunteers will have three visits. At Visit 1, participants will undergo a medical history, physical examination, and laboratory tests. Healthy volunteers will have a Mini-Mental State Examination (MMSE) cognitive function test. Participants with AD will have a MMSE and measurement of the severity of their dementia.
During Visit 2, participants will undergo a magnetic resonance imaging (MRI) scan of the brain.
At Visit 3, participants will undergo SPECT imaging.
Only participants with AD will participate in Visit 4. During this visit, cognitive testing will be performed.
Studieoversikt
Detaljert beskrivelse
Studietype
Registrering
Kontakter og plasseringer
Studiesteder
-
-
Maryland
-
Bethesda, Maryland, Forente stater, 20892
- National Institute of Mental Health (NIMH)
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
INCLUSION CRITERIA - ALZHEIMER'S DISEASE PATIENTS:
All AD patients will meet NINCDS-ADRDA criteria for probable AD with age of onset between 50 and 65 years of age.
The AD patients will be mild to moderately demented as assessed by the Mattis Dementia Rating Scale and Mini-Mental State Examination.
In particular, the AD patients will be nonsmokers because of known effects of smoking on nAChRs.
Patients will be characterized by their APOE genotype as nAChR changes might be different with differing doses of this allele.
We will not exclude AD patients from participating while they are on AChe inhibitors.
EXCLUSION CRITERIA - ALZHEIMER'S DISEASE PATIENTS:
We will exclude patients who are on galanthamine (Reminyl).
We will exclude patients on antidepressants and/or psychotropic drugs.
INCLUSION CRITERIA - CONTROLS:
Nonsmoking healthy individuals who satisfy the inclusion and exclusion criteria.
Studieplan
Hvordan er studiet utformet?
Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Corder EH, Saunders AM, Strittmatter WJ, Schmechel DE, Gaskell PC, Small GW, Roses AD, Haines JL, Pericak-Vance MA. Gene dose of apolipoprotein E type 4 allele and the risk of Alzheimer's disease in late onset families. Science. 1993 Aug 13;261(5123):921-3. doi: 10.1126/science.8346443.
- Saunders AM, Strittmatter WJ, Schmechel D, George-Hyslop PH, Pericak-Vance MA, Joo SH, Rosi BL, Gusella JF, Crapper-MacLachlan DR, Alberts MJ, et al. Association of apolipoprotein E allele epsilon 4 with late-onset familial and sporadic Alzheimer's disease. Neurology. 1993 Aug;43(8):1467-72. doi: 10.1212/wnl.43.8.1467.
- Coyle JT, Puttfarcken P. Oxidative stress, glutamate, and neurodegenerative disorders. Science. 1993 Oct 29;262(5134):689-95. doi: 10.1126/science.7901908.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Studiet fullført
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 020058
- 02-M-0058
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. .
Kliniske studier på [123] 5-I-A-85380
-
Oregon Center for Applied Science, Inc.Eunice Kennedy Shriver National Institute of Child Health and Human Development...Fullført
-
Oregon Research InstituteNational Institute on Drug Abuse (NIDA)FullførtOpphør av tobakksbrukForente stater
-
Dong-A ST Co., Ltd.FullførtType 2 diabetesKorea, Republikken
-
Yale UniversityNational Institute on Drug Abuse (NIDA); Nabi BiopharmaceuticalsFullført
-
Children's Hospital of PhiladelphiaUniversity of PennsylvaniaFullført
-
Dong-A ST Co., Ltd.FullførtType 2 diabetesKorea, Republikken
-
Coopervision, Inc.Fullført
-
The University of Texas Medical Branch, GalvestonAmerican Heart AssociationFullført
-
Grifols Therapeutics LLCInstituto Grifols, S.A.RekrutteringAkutt-på-kronisk leversviktForente stater, Storbritannia, Spania, Tyskland, Italia, Belgia, Frankrike, Østerrike, Danmark, Portugal