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Trial record 4 of 158 for:    (Dementia pugilistica OR chronic traumatic encephalopathy) AND Injuries

18F-AV-1451 and Florbetapir F 18 PET Imaging in Subjects at Risk for Chronic Traumatic Encephalopathy

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ClinicalTrials.gov Identifier: NCT02079766
Recruitment Status : Completed
First Posted : March 6, 2014
Last Update Posted : February 9, 2017
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals

Brief Summary:
This study will explore the use of 18F-AV-1451 as a biomarker for chronic traumatic encephalopathy (CTE) and examine the relationship between clinical presentation and tau deposition.

Condition or disease Intervention/treatment Phase
Chronic Traumatic Encephalopathy Drug: florbetapir F 18 Drug: 18F-AV-1451 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 18F-AV-1451 and Florbetapir F 18 PET Imaging in Subjects With Repetitive Brain Trauma at High Risk for Chronic Traumatic Encephalopathy
Study Start Date : June 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High Risk of CTE
Subjects at high risk of developing CTE (former National Football League players) will receive a single IV injection, 370 megabecquerel (MBq) [10 millicurie (mCi)] of florbetapir F 18 and a single IV injection, 370 MBq (10 mCi) of 18F-AV-1451.
Drug: florbetapir F 18
Other Names:
  • Amyvid
  • 18F-AV-45

Drug: 18F-AV-1451
Other Name: T807

Experimental: Control
Control subjects (former non-contact athletes) will receive a single IV injection, 370 megabecquerel (MBq) [10 millicurie (mCi)] of florbetapir F 18 and a single IV injection, 370 MBq (10 mCi) of 18F-AV-1451.
Drug: florbetapir F 18
Other Names:
  • Amyvid
  • 18F-AV-45

Drug: 18F-AV-1451
Other Name: T807




Primary Outcome Measures :
  1. CTE Biomarker Analysis [ Time Frame: Up to 105 minutes post injection ]
    18F-AV-1451 uptake and florbetapir F 18 standard uptake value ratio (SUVR) will be compared in subjects with a high risk of CTE and controls.

  2. Relationship Between Clinical Presentation and Tau Deposition [ Time Frame: Up to 105 minutes post injection ]
    The relationship among 18F-AV-1451 uptake, florbetapir SUVR, and measurements including neuropsychological assessment battery (NAB) List and Story Learning tests, Trail Making Test - Parts A and B, Wisconsin Card Sorting Test, Wechsler Adult Intelligence Scale - Revised (WAIS-R), Animal Fluency, NAB Naming Test, NAB Map Reading Test and Mini-Mental State Examination (MMSE).



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male subjects consented and currently enrolled in the Diagnosing and Evaluating Traumatic Encephalopathy Using Clinical Tests (DETECT) or the Long-Term Consequences of Repetitive Brain Injury in Athletes study protocols
  • Can tolerate up to two PET imaging sessions
  • Have the ability to provide informed consent for study procedures

Exclusion Criteria:

  • Claustrophobia
  • Current clinically significant cardiovascular disease or clinically significant abnormalities on screening ECG
  • History of risk factors for Torsades de Pointes or are taking drugs known to cause QT-prolongation
  • Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer that the investigator believes would affect study participation or scan results
  • Have had a non-study related radiopharmaceutical imaging or treatment within 7 days prior to study PET imaging sessions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02079766


Locations
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United States, Arizona
Banner Alzheimer's Institute
Phoenix, Arizona, United States, 85006
United States, Massachusetts
Boston University
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Avid Radiopharmaceuticals
Investigators
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Study Chair: Chief Medical Officer Avid Radiopharmaceuticals, Inc.

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Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT02079766     History of Changes
Other Study ID Numbers: 18F-AV-1451-A07
First Posted: March 6, 2014    Key Record Dates
Last Update Posted: February 9, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Brain Injuries, Traumatic
Chronic Traumatic Encephalopathy
Brain Injuries
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Brain Injury, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases