- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01265394
Positron Emission Tomography (PET) Amyloid Imaging of the Brain in Healthy Young Adult Subjects
A Single-arm, Open-label, Multi-center Study to Determine the Specificity of Flutemetamol (18F) Injection for Excluding the Presence of Brain Amyloid in Healthy Young Adult Subjects Aged 18 to 40
Studieoversigt
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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New Jersey
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Princeton, New Jersey, Forenede Stater, 08540
- GE Healthcare
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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:
- The subject age is 18 to 40 years.
- The subject has no evidence of thinking or memory problems by medical history.
- The subject has a normal MRI scan.
- The subject's general health is adequate to comply with study procedures.
- The subject is willing and able to participate in all study procedures.
Exclusion Criteria:
- The subject has received any medical ionizing radiation exposure in the last 12 months (except planar x-ray or head CT).
- The subject has a contraindication for (cannot undergo) MRI.
- The subject has a history of head injury with loss of consciousness.
- The subject has any significant medical, psychiatric or neurological condition that might be associated with brain pathology.
- The subject has a family history of Alzheimer's Disease (AD); more than 1 first-degree relative.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: (18F) Flutemetamol
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Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of Brain Scans in Healthy Young Adults Subjects Which do Not Show Amyloid
Tidsramme: PET scans performed on patients 90 minutes post Flutemetmol Administration
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The visual assessment of Flutemetamol PET image was performed by independent readers trained in the evaluation of PET brain amyloid imaging. The measure would consisted of the number of brain scans with amyloid (abnormal reading) or without amyloid (normal reading). |
PET scans performed on patients 90 minutes post Flutemetmol Administration
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Measurement of Amyloid Content in Different Parts of the Brain
Tidsramme: PET scans performed on patients 90 minutes post Flutemetmol Administration
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Is the computerized measurement of amyloid content in different parts of the brain. The Standard Uptake Value Ratio (SUVR) is defined as an average of frontal, anterior cingulate, pariteal, lateral-temporal and posterior cingulate / precuneous uptake following administration of Flutemetamol F18 Injection. The Standard Uptake Value Ratio is calculated for two regions of the brain, the Cerebullum and the Pons regions. The Standard Uptake Value Ratio is calculated for two regions of the brain, the Cerebullum and the Pons regions. Both regions of the brain will provide the SUVR measurements. |
PET scans performed on patients 90 minutes post Flutemetmol Administration
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Paul Sherwin, MD, PhD, GE Healthcare
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 (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- GE-067-015
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Kliniske forsøg med [18F] Flutemetamol
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-
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