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COMPLETED Phase 2

Phase II Study of Florbetaben (BAY94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid.

NCT00928304 · View on ClinicalTrials.gov ↗

Study Summary

To determine the sensitivity of the visual assessment of BAY94-9172 PET images in detecting cerebral β-amyloid in individuals with Down Syndrome (DS) and specificity in individuals without DS. Given that individuals with Down Syndrome develop β-amyloid pathology over the age of 40, the clinical diagnosis of Down Syndrome will serve as the standard of truth.

Interventions

  • DRUG Florbetaben (BAY94-9172)

Study Locations (2)

Arizona

  • — Sun City

Connecticut

  • — New Haven

Trial Details

FieldValue
Enrollment Target 109 participants
Start Date 2009-06
Est. Completion 2011-01
Phase Phase 2

Sponsor

Life Molecular Imaging

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00928304

The ClinicalTrials.gov registry entry for NCT00928304 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 109 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Life Molecular Imaging, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Down Syndrome appearing as the primary indexed condition, and to 1 intervention — of which Florbetaben (BAY94-9172) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00928304 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Arizona, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00928304 about?

NCT00928304 is a clinical study titled "Phase II Study of Florbetaben (BAY94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid.". To determine the sensitivity of the visual assessment of BAY94-9172 PET images in detecting cerebral β-amyloid in individuals with Down Syndrome (DS) and specificity in individuals without DS. Given that individuals with Down Syndrome develop β-amyloid pathology over the age of 40, the clinical diag...

What is the current status of trial NCT00928304?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 109 participants. The study started on 2009-06. Estimated completion is 2011-01.

What conditions does trial NCT00928304 study?

This clinical trial studies the following conditions: Down Syndrome, Amyloid Beta-protein. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00928304?

The interventions under investigation include: Florbetaben (BAY94-9172) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00928304?

This trial is sponsored by Life Molecular Imaging, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00928304 being conducted?

This trial has 2 study locations across Arizona, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial