Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 2 study of Down Syndrome and Amyloid Beta-protein, sponsored by Life Molecular Imaging.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary variables are sensitivity (percentage of DS subjects positive for cerebral beta-amyloid) and specificity (percentage of healthy volunteers negative for cerebral beta-amyloid) of brain uptake of florbetaben based on the majority read of the visual assessment by three independent blinded readers of PET images obtained 100 to 120 minutes post-injection of florbetaben.
Conditions Studied
Interventions
- DRUG Florbetaben (BAY94-9172)
Study Locations (2)
Arizona
- - Sun City
Connecticut
- - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2009-06 |
| Est. Completion | 2011-01 |
| Phase | Phase 2 |
What the finished NCT00928304 record still lists
NCT00928304 is an interventional study that assigns participants to a tested intervention. The registered 109 participants enrollment target is mid-sized for trials with a published cap, below the 2,470-participant average among 54 other Down Syndrome trials with a reported enrollment target (96% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Down Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00928304's enrollment target sits among peer trials
109 23rd of 54 higher than 32 of 54 other Down Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Down Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL)
RECRUITING · Phase 2
-
Medications for Obstructive Sleep Apnea to Improve Cognition in Children With Down Syndrome
RECRUITING · Phase 2
-
Down Syndrome Obstructive Sleep Apnea
RECRUITING · Phase 2
-
Cholinergic Integrity in Down Syndrome in Association With Aging, Alzheimer's Disease Pathology, and Cognition
ACTIVE NOT RECRUITING · Phase 2
-
Therapies for Down Syndrome Regression Disorder
ACTIVE NOT RECRUITING · Phase 2
-
Medications for Obstructive Sleep Apnea In Children With Down Syndrome
COMPLETED · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02421380 · 109 participants · NA
Characterization of Hyperpolarized Pyruvate MRI Reproducibility
- NCT04526600 · 109 participants · NA
Fidgeting and Attentional and Emotional Regulation in ADHD
- NCT04835584 · 109 participants · Phase 1
KRT-232 and TKI Study in Chronic Myeloid Leukemia
- NCT06626516 · 109 participants · Phase 1
Tebentafusp-tebn With LDT in Metastatic UM
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia