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NCT00857506 · ClinicalTrials.gov registry record · Phase 2
Observational Study of Cognitive Outcomes for Subjects Who Have Had Prior PET Amyloid Imaging With Florbetapir F 18 (18F-AV-45)
A Phase 2 study, sponsored by Avid Radiopharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 152
- Enrollment target
NCT00857506: Completed Phase 2 study, sponsored by Avid Radiopharmaceuticals.
NCT00857506 is a Phase 2 study that has completed, run by Avid Radiopharmaceuticals. The registered enrollment target is 152 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00857506, a Phase 2 study, has completed, sponsored by Avid Radiopharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 152 participants
- Enrollment target
Study Summary
The primary objective of this protocol is to determine if brain amyloid imaged with florbetapir F 18 (18F-AV-45) PET scans is predictive of progressive cognitive impairment during the subsequent 36 months for groups of: normal controls, mild cognitive impairment and Alzheimer's disease. Hypothesis 1: The probability a subject will experience progressive cognitive impairment within 36 months of imaging will be greater in subjects whose 18F-AV-45 PET scan was rated amyloid positive compared to subjects whose PET scan was rated amyloid negative. The secondary objective is to determine the stability, over 36 months of a clinical diagnosis, of AD in patients with an amyloid positive 18F-AV-45 PET. Hypothesis 2: The diagnosis of AD will remain unchanged in patients whose PET scan were rated as amyloid positive.
Primary Outcome
The primary analysis was the comparison in the magnitude of change from baseline in Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-Cog) between Aβ+ and Aβ- subjects in the Mild Cognitive Impairment (MCI) population at 36 months adjusting for baseline test score and age at informed consent. ADAS-Cog scores (range 0-70) indicate performance on a series of 11 cognitive tasks where 0 indicates the highest level of cognitive performance and 70 indicates the lowest level of cognitive pe
Interventions
- DRUG florbetapir F 18
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2009-01 |
| Est. Completion | 2011-12 |
| Phase | Phase 2 |
What the finished NCT00857506 record still lists
NCT00857506 is an interventional study that assigns participants to a tested intervention. The registered 152 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% higher).
The record links to 0 conditions, and to 1 intervention - of which florbetapir F 18 is the first listed.
NCT00857506 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00857506 about?
NCT00857506 is a clinical study titled "Observational Study of Cognitive Outcomes for Subjects Who Have Had Prior PET Amyloid Imaging With Florbetapir F 18 (18F-AV-45)". The primary objective of this protocol is to determine if brain amyloid imaged with florbetapir F 18 (18F-AV-45) PET scans is predictive of progressive cognitive impairment during the subsequent 36 months for groups of: normal controls, mild cognitive impairment and Alzheimer's disease. Hypothesis ...
What is the current status of trial NCT00857506?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 152 participants. The study started on 2009-01. Estimated completion is 2011-12.
What interventions are being tested in trial NCT00857506?
The interventions under investigation include: florbetapir F 18 (DRUG).
Who is sponsoring clinical trial NCT00857506?
This trial is sponsored by Avid Radiopharmaceuticals, which has 42 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00857506's enrollment target sits among peer trials
152 452nd of 2000 higher than 1,547 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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