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NCT01607476 · ClinicalTrials.gov registry record · Phase 2
Bridging Study of C11 Pittsburgh Compound B (PiB) and F18 Flutemetamol Brain Positron Emission Tomography (PET)
A Phase 2 study of Alzheimers Disease, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 2
- Development phase
- 89
- Enrollment target
- 1
- Study location
NCT01607476: Completed Phase 2 study of Alzheimers Disease, sponsored by Mayo Clinic.
NCT01607476 is a Phase 2 study of Alzheimers Disease that has completed, run by Mayo Clinic. The registered enrollment target is 89 participants, below the 3,926-participant average among 147 other Alzheimers Disease trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01607476, a Phase 2 study of Alzheimers Disease, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 89 participants
- Enrollment target
- 1
- Study location
Study Summary
The intent of this research protocol is to test the equivalency of two amyloid imaging drugs (C11 Pittsburgh Compound B and F18 Flutemetamol). The investigators hypothesize that there will be no significant difference in the distribution of the agents to areas of amyloid deposition in the brain or to other normal brain structures. Recent data have shown similarity in the distribution of the drugs in subjects with Alzheimer's disease (AD) or mild cognitive impairment (MCI). No comparison data of the two PET drugs in normal subjects has been published. It is important to understand differences in the images and biodistribution from the two drugs in normal subjects as nonspecific accumulation of the drugs in brain structures such as white matter appear to differ slightly and could affect image performance.
Primary Outcome
The imaging analysts use a global atlas of the brain to measure the uptake of the radioactive tracer (or brightness) globally. This global uptake was normalized to the uptake in the cerebellar crus region of the brain to get a global Standard Uptake Value Ratio (SUVR). The cerebral crus (crus cerebri) is the anterior portion of the cerebral peduncle which contains the motor tracts. The standard uptake value (SUV) is a way of determining activity in PET imaging. The SUVR is the ratio of SUV from
Conditions Studied
Interventions
- DRUG C11 PiB
- DRUG F18 Flutametamol
Study Locations (1)
Minnesota
- Mayo Clinic Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2012-07 |
| Est. Completion | 2016-03 |
| Phase | Phase 2 |
What the finished NCT01607476 record still lists
NCT01607476 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 89 participants, a relatively small participant target, below the 3,926-participant average among 147 other Alzheimers Disease trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Alzheimers Disease appearing as the primary indexed condition, and to 2 interventions - of which C11 PiB is the first listed.
NCT01607476 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT01607476 about?
NCT01607476 is a clinical study titled "Bridging Study of C11 Pittsburgh Compound B (PiB) and F18 Flutemetamol Brain Positron Emission Tomography (PET)". The intent of this research protocol is to test the equivalency of two amyloid imaging drugs (C11 Pittsburgh Compound B and F18 Flutemetamol). The investigators hypothesize that there will be no significant difference in the distribution of the agents to areas of amyloid deposition in the brain or t...
What is the current status of trial NCT01607476?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 89 participants. The study started on 2012-07. Estimated completion is 2016-03.
What conditions does trial NCT01607476 study?
This clinical trial studies the following conditions: Alzheimers Disease.
What interventions are being tested in trial NCT01607476?
The interventions under investigation include: C11 PiB (DRUG), F18 Flutametamol (DRUG).
Who is sponsoring clinical trial NCT01607476?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01607476 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01607476's enrollment target sits among peer trials
89 81st of 147 higher than 67 of 147 other Alzheimers Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimers Disease 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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