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NCT00954369 · ClinicalTrials.gov registry record · Early Phase 1
Exploratory and Safety Study of [F-18]W372
A Early Phase 1 study, sponsored by Siemens Molecular Imaging.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 24
- Enrollment target
NCT00954369 is a Early Phase 1 study that has completed, run by Siemens Molecular Imaging. The registered enrollment target is 24 participants.
The verdict
NCT00954369, a Early Phase 1 study, has completed, sponsored by Siemens Molecular Imaging.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
PHASE: Phase 0, Exploratory Study OBJECTIVES: To collect drug safety, bio-distribution and dosimetry data, to begin collection of PET/CT imaging data, to acquire experience to improve study design and the conduct of future studies. DESIGN: Exploratory, open label, non-randomized, multi-center study. DURATION: Three visits - one screening, one imaging, and one follow-up visit at 24 hours post-dose PROCEDURES: Informed consent, collection of demographic information and medical history, administration of mental status exam, physical examination, vital signs, 12-lead ECGs, routine blood tests to assess major organ functions, complete blood counts and clinical chemistries for safety, dosing with \[F-18\]W372, PET imaging scans of brain (in sixteen subjects), whole body PET imaging and urine collections for dosimetry evaluation (in four subjects only), observation and interviews following imaging to collect adverse events. SUBJECTS: Twenty (20) subjects ≥ 55 years old: Group 1 will consist of 10 subjects who have a low probability of being currently positive for Alzheimer's Disease (AD) as defined by the protocol criteria (MMSE ≥ 28). Four of the 10 subjects will undergo whole body PET imaging for dosimetry evaluations, and 6 of the 10 subjects will undergo PET imaging of the brain only. Group 2 will consist of 10 subjects who have a high probability of currently being positive for AD as defined by the protocol criteria (MMSE \< 24); these 10 subjects will undergo PET imaging of the brain only.
Interventions
- DRUG [F-18]W372
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2009-08 |
| Est. Completion | 2010-02 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00954369
The ClinicalTrials.gov registry entry for NCT00954369 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Siemens Molecular Imaging, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which [F-18]W372 is the first listed.
NCT00954369 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00954369 about?
NCT00954369 is a clinical study titled "Exploratory and Safety Study of [F-18]W372". PHASE: Phase 0, Exploratory Study OBJECTIVES: To collect drug safety, bio-distribution and dosimetry data, to begin collection of PET/CT imaging data, to acquire experience to improve study design and the conduct of future studies. DESIGN: Exploratory, open label, non-randomized, multi-center stud...
What is the current status of trial NCT00954369?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 24 participants. The study started on 2009-08. Estimated completion is 2010-02.
What interventions are being tested in trial NCT00954369?
The interventions under investigation include: [F-18]W372 (DRUG).
Who is sponsoring clinical trial NCT00954369?
This trial is sponsored by Siemens Molecular Imaging, which has 9 total clinical trials registered on ClinicalTrials.gov.
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