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NCT01028053 · ClinicalTrials.gov registry record · Phase 3
Assess the Prognostic Usefulness of Flutemetamol (18F) Injection for Identifying Subjects With Amnestic Mild Cognitive Impairment Who Will Convert to Clinically Probable Alzheimer's Disease
A Phase 3 study of Mild Cognitive Impairment and Alzheimers Disease, sponsored by GE Healthcare.
- Completed
- Registry status
- Phase 3
- Development phase
- 365
- Enrollment target
- 1
- Study location
NCT01028053: Completed Phase 3 study of Mild Cognitive Impairment and Alzheimers Disease, sponsored by GE Healthcare.
NCT01028053 is a Phase 3 study of Mild Cognitive Impairment and Alzheimers Disease that has completed, run by GE Healthcare. The registered enrollment target is 365 participants, below the 1,269-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01028053, a Phase 3 study of Mild Cognitive Impairment and Alzheimers Disease, has completed, sponsored by GE Healthcare.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 365 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will investigate the efficacy of the Flutemetamol (18F) Injection PET tracer in identifying abnormal (18F) flutemetamol uptake patterns which predict the conversion from aMCI to a b-amyloid associated clinically probable Alzheimer's disease.
Primary Outcome
Visual Interpretation of the PET scan by independent readers. Note: The statistic Hazard ratio (HR) is the ratio of the hazard rates in the 2 groups (1 group being normal (negative for amyloid B) and 1 group being abnormal (positive for amyloid B). Under the null hypothesis of equal rates, the HR would be equal to 1. As the HR increases above 1, the chances of being probable Alzheimer's Disease (pAD) also increases. Note: Eight Subjects who withdrew prior to the first Clinical Adjudication Co
Conditions Studied
Interventions
- DRUG Flutemetamol (18F) Injection
Study Locations (1)
New Jersey
- GE Healthcare - Princeton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 365 participants |
| Start Date | 2009-12 |
| Est. Completion | 2014-01 |
| Phase | Phase 3 |
What the finished NCT01028053 record still lists
NCT01028053 is an interventional study that assigns participants to a tested intervention. The registered 365 participants enrollment target is mid-sized for trials with a published cap, below the 1,269-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (71% lower).
The record links to 2 conditions, with Mild Cognitive Impairment appearing as the primary indexed condition, and to 1 intervention - of which Flutemetamol (18F) Injection is the first listed.
NCT01028053 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT01028053 about?
NCT01028053 is a clinical study titled "Assess the Prognostic Usefulness of Flutemetamol (18F) Injection for Identifying Subjects With Amnestic Mild Cognitive Impairment Who Will Convert to Clinically Probable Alzheimer's Disease". This study will investigate the efficacy of the Flutemetamol (18F) Injection PET tracer in identifying abnormal (18F) flutemetamol uptake patterns which predict the conversion from aMCI to a b-amyloid associated clinically probable Alzheimer's disease.
What is the current status of trial NCT01028053?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 365 participants. The study started on 2009-12. Estimated completion is 2014-01.
What conditions does trial NCT01028053 study?
This clinical trial studies the following conditions: Mild Cognitive Impairment, Alzheimers Disease.
What interventions are being tested in trial NCT01028053?
The interventions under investigation include: Flutemetamol (18F) Injection (DRUG).
Who is sponsoring clinical trial NCT01028053?
This trial is sponsored by GE Healthcare, which has 99 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01028053 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01028053's enrollment target sits among peer trials
365 27th of 205 higher than 179 of 205 other Mild Cognitive Impairment trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mild Cognitive Impairment 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.
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