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Brain DiseaseNCT02211820

PET Imaging in Chronic Traumatic Encephalopathy

An observational study of Brain Disease and Brain Mapping, run by National Institute of Mental Health (NIMH) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: Chronic traumatic encephalopathy (CTE) is a brain disease caused in part by head injury. The brain changes from CTE can only be seen at autopsy. Researchers want to test a new brain scan to help diagnose CTE in living patients. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Brain Disease, Brain Mapping
How many people
6 participants
Where
1 siteUnited States
Study dates
1 Aug 2014to 12 Oct 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • <TAB>
  • For patients:
  • History of head injury resulting from past or current participation in one or more contact sports (hockey, football, or boxing). Patients may have history of structural brain injury (i.e., injury accompanying abnormality on MRI or CT scan), concussion without structural injury (mild TBI), or repetitive sub-concussive injury.
  • Meets DMS-V criteria for Major Neurocognitive Disorder or Mild Neurocognitive Disorder
  • Age 18 to 60 years.
  • Ambulatory.
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  • Patients unable to provide informed consent must have a surrogate decision maker.
  • For healthy controls:
  • Healthy without past or present history of brain disease.
  • Age 18 to 60 years.
  • Able to provide informed consent.

Who cannot join

  • Past or present history of a brain disorder other than TBI.
  • For patients: Subjects with abnormal brain imaging findings that suggest a diagnosis other than TBI or a second lesion such as brain tumor in addition to the changes consistent with TBI.
  • For controls: past or present history of either a single concussion or more severe TBI, or of repetitive sub-concussive injury due to contact sport participation.
  • Serious medical conditions, which make study procedures of the current study unsafe. Such serious medical conditions include uncontrolled epilepsy and multiple serious injuries. The Principal Investigator of this protocol will determine whether the subject needs to be excluded.
  • The DSM-V criteria for Major Neurocognitive Disorder are as follows:
  • --Evidence of significant cognitive decline from a previous level of performance in one or more cognitive domains (complex attention, executive function, learning and memory, perceptual-motor, or social cognition) based on:
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  • Concern of the individual, a knowledgeable informant, of the clinician that there has been a significant decline in cognitive function.
  • A substantial impairment in cognitive performance, preferably documented by standardized neuropsychological testing, or, in its absence, another qualified clinical assessment.
  • The cognitive deficits interfere with independence in everyday activities (i.e. at a minimum, requiring assistance with complex instrumental activities of daily living such as paying bills or managing medications)
  • The cognitive deficits do not occur exclusively in the context of delirium.
  • The cognitive disorder is not better explained by another mental disorder (e.g. major depressive disorder, schizophrenia).
  • Criteria for Mild Neurocognitive Disorder are as follows:
  • There is evidence of modest cognitive decline from a previous level of performance in one or more of the domains outlined above based on:
  • Concern of the individual, a knowledgeable informant, or the clinician.
  • Decline in neurocognitive performance, preferably documented by standardized neuropsychological testing, or, in its absence, another qualified clinical assessment.
  • The cognitive deficits are insufficient to interfere with independence (eg, instrumental activities of daily living, like more complex tasks such as paying bills or managing medications,
  • are preserved), but greater effort, compensatory strategies, or accommodation may be required to maintain independence.
  • The cognitive deficits do not occur exclusively in the context of a delirium.
  • The cognitive deficits are not primarily attributable to another mental disorder (eg, major depressive disorder, schizophrenia).
  • There are no restrictions on medications. Since disease modifying therapy for tauopathies (including CTE and Alzheimer s disease) do not currently exist, no currently available medications, either prescribed or over-the-counter, are expected to confound the results of this study. Anti-inflammatory medications, including NSAIDs, are not expected to significantly reduce tau aggregation in CTE patients, based on the failure of these medications to prevent disease progression in Alzheimer s disease.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Background:

  • Chronic traumatic encephalopathy (CTE) is a brain disease caused in part by head injury. The brain changes from CTE can only be seen at autopsy. Researchers want to test a new brain scan to help diagnose CTE in living patients.
Read more

Objective:

  • To determine if a new type of brain scan can detect changes that occur in chronic traumatic encephalopathy.

Eligibility:

  • Adults age 18 60 with previous head injury or participation in certain sports.

Design:

  • Participants will be screened with:
  • Physical exam
  • Blood and urine tests
  • Tests of thinking, mood, and memory
  • 30-minute magnetic resonance imaging (MRI) brain scan. A magnetic field and radio waves take pictures of the brain. Participants will lie on a table that slides into a metal cylinder. They will get earplugs for the loud knocking sounds.
  • Visit 1: Participants will have a 70-minute PET scan of the brain with a small amount of a radioactive chemical. That will be injected through an intravenous tube (catheter) in each arm. A catheter will also be put into an artery at the wrist or elbow.
  • Participants will lie on a bed that slides in and out of a donut-shaped scanner. A plastic mask may be molded to their face and head. Vital signs and heart activity will be checked before and during the scan.
  • Blood and urine will be taken before and after the scan.
  • Participants will be checked on by phone the next day.
  • Visit 2: Participants will repeat Visit 1 with a different chemical and no artery catheter.
  • Visit 3: Participants may have a spinal tap. Some fluid will be removed by needle between the bones in the back.
Read the detailed description

Objective: To determine if the PET radioligand [11C]PBB3 can detect aggregates of tau protein in the brains of patients with history of traumatic brain injury (TBI) and suspected chronic traumatic encephalopathy (CTE).

Study population: The proposed study will include 40 subjects. Twenty will be patients with history of TBI and suspected CTE and 20 will be healthy cognitively normal volunteers without history of TBI.

Design: Subjects will undergo medical screening and have brain MRI and neuropsychological testing performed. Subjects will undergo one brain PET scan with [11C]PBB3 to detect aggregates of tau protein. Subjects will also have one brain PET scan with [11C]Pittsburgh compound B (PIB) to detect amyloid plaques. Subjects will be asked to have a lumbar puncture to measure CSF tau concentrations.

Outcome measures: The primary outcome measure will be the amount of [11C]PBB3 binding in the brain. We will quantify the radioligand s brain uptake, washout, plasma clearance, and distribution volume using compartmental modeling. Distribution volume of [11C]PBB3 is proportional to the density of insoluble paired helical filaments of tau and is equal to the ratio at equilibrium of uptake in brain to the concentration of parent radiotracer in plasma. As an exploratory measure, we will determine if there is a relationship between [11C]PBB3 binding in brain and gray matter loss on MRI. We will also measure the amount of [11C]PIB binding in the brain using the Logan reference tissue method with cerebellum as reference.

Keywords
Encephalopathy, Imaging Studies, Dementia, Cerebellar Cortical Atrophy
Medical subject headings
Brain Diseases, Dementia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Amount of 11C-PBB3 binding in brain as measured with PET

    Measured: 1 year

Secondary outcomes (1)

  1. Amount of brain atrophy as measured with MRI.Amount of 11C-PIB binding in brain as measured with PET

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2014 (estimated)
  2. Study start1 Aug 2014
  3. Primary completion20 Jun 2016
  4. Study completion12 Oct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02211820
Sponsor's protocol ID
140164
Other IDs
14-M-0164
Status last verified
12 Oct 2016
First submitted
7 Aug 2014
Last updated
5 Jul 2018
Results posted
No

Publications

  • Baugh CM, Stamm JM, Riley DO, Gavett BE, Shenton ME, Lin A, Nowinski CJ, Cantu RC, McKee AC, Stern RA. Chronic traumatic encephalopathy: neurodegeneration following repetitive concussive and subconcussive brain trauma. Brain Imaging Behav. 2012 Jun;6(2):244-54. doi: 10.1007/s11682-012-9164-5.

    PubMed 22552850

  • Braskie MN, Klunder AD, Hayashi KM, Protas H, Kepe V, Miller KJ, Huang SC, Barrio JR, Ercoli LM, Siddarth P, Satyamurthy N, Liu J, Toga AW, Bookheimer SY, Small GW, Thompson PM. Plaque and tangle imaging and cognition in normal aging and Alzheimer's disease. Neurobiol Aging. 2010 Oct;31(10):1669-78. doi: 10.1016/j.neurobiolaging.2008.09.012. Epub 2008 Nov 11.

    PubMed 19004525

  • Chien DT, Bahri S, Szardenings AK, Walsh JC, Mu F, Su MY, Shankle WR, Elizarov A, Kolb HC. Early clinical PET imaging results with the novel PHF-tau radioligand [F-18]-T807. J Alzheimers Dis. 2013;34(2):457-68. doi: 10.3233/JAD-122059.

    PubMed 23234879

Questions about this trial

What is this clinical trial studying?

An observational study of Brain Disease and Brain Mapping, run by National Institute of Mental Health (NIMH) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Amount of 11C-PBB3 binding in brain as measured with PET (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02211820, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2018; AzTrials last refreshed its copy on 29 Oct 2026.

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