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NCT00928304 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Down Syndrome and Amyloid Beta-protein, sponsored by Life Molecular Imaging.

Completed
Registry status
Phase 2
Development phase
109
Enrollment target
2
Study locations

NCT00928304 is a Phase 2 study of Down Syndrome and Amyloid Beta-protein that has completed, run by Life Molecular Imaging. The registered enrollment target is 109 participants, below the 2,470-participant average among 54 other Down Syndrome trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT00928304, a Phase 2 study of Down Syndrome and Amyloid Beta-protein, has completed, sponsored by Life Molecular Imaging.

COMPLETED
Registry status
Phase 2
Development phase
109 participants
Enrollment target
2
Study locations

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.

Conditions Studied

Down Syndrome Amyloid Beta-protein

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, categorized as Phase 2. The registered enrollment target is 109 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,470-participant average among 54 other Down Syndrome trials with a reported enrollment target (96% lower). The listed sponsor is Life Molecular Imaging, which has 4 total studies on file at ClinicalTrials.gov.

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.

NCT00928304 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Arizona, Connecticut.

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.

What interventions are being tested in trial NCT00928304?

The interventions under investigation include: Florbetaben (BAY94-9172) (DRUG).

Who is sponsoring clinical trial NCT00928304?

This trial is sponsored by Life Molecular Imaging, which has 4 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.