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NCT02191267 · ClinicalTrials.gov registry record · Phase 2
Tau Imaging of Chronic Traumatic Encephalopathy
A Phase 2 study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT02191267 is a Phase 2 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 30 participants.
The verdict
NCT02191267, a Phase 2 study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
Chronic traumatic encephalopathy (CTE) is a progressive degenerative brain disease with symptoms that include memory loss, problems with impulse control, and depression that can lead to suicide. As the disease progresses, it can lead to dementia. Currently CTE can only be diagnosed postmortem where an over-accumulation of a protein called tau is observed. There is now a new experimental measure that makes it possible, for the first time, to measure tau protein in the living human brain using a novel positron emission tomography (PET) ligand, \[F-18\] AV-1451 (aka, \[18F\]-T807). The main objective of this study is to use a novel PET approach to measure tau accumulation in the brain. The presence of CTE at autopsy in deceased National Football League (NFL) players has been well documented. Accordingly, we will conduct this study in a group of retired NFL players who have clinical symptoms of CTE and are suspected of having CTE based on high levels of tau in their spinal fluid and abnormalities seen on research brain scans. We will compare them with a control group of former elite level athletes who have not experienced any brain trauma, deny any clinical symptoms, and who have completely normal spinal fluid tau and amyloid levels, and brain scans. We will also include a group of subjects with AD. All participants will be recruited from ongoing studies, headed by the Partnering PI of this proposal, Dr. Robert Stern, at the Boston University Center for the Study of Traumatic Encephalopathy and the Alzheimer's Disease Center. We will use both a beta amyloid PET scan (\[18F\]-florbetapir) and a tau PET scan (\[18F\]-T807) on consecutive days. With the beta amyloid scan we expect little or no evidence of amyloid in the NFL players with presumed CTE, and no evidence of amyloid in the control group of athletes with no history of repetitive brain trauma. In contrast we expect to see beta amyloid accumulation in the AD patient brains. With the new tau ligand, we expect that
Interventions
- RADIATION [F18]-T807
- RADIATION [F18]-Florbetapir
- DEVICE MRI/MRS
- GENETIC Genetic Analysis for Genetic Risk Score for Tau.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2015-01 |
| Est. Completion | 2016-09-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02191267
The ClinicalTrials.gov registry entry for NCT02191267 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which [F18]-T807 is the first listed.
NCT02191267 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02191267 about?
NCT02191267 is a clinical study titled "Tau Imaging of Chronic Traumatic Encephalopathy". Chronic traumatic encephalopathy (CTE) is a progressive degenerative brain disease with symptoms that include memory loss, problems with impulse control, and depression that can lead to suicide. As the disease progresses, it can lead to dementia. Currently CTE can only be diagnosed postmortem where ...
What is the current status of trial NCT02191267?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2015-01. Estimated completion is 2016-09-30.
What interventions are being tested in trial NCT02191267?
The interventions under investigation include: [F18]-T807 (RADIATION), [F18]-Florbetapir (RADIATION), MRI/MRS (DEVICE), Genetic Analysis for Genetic Risk Score for Tau. (GENETIC).
Who is sponsoring clinical trial NCT02191267?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
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