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Trial record 6 of 69 for:    avid

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Avid Radiopharmaceuticals
Sponsor:
Collaborator:
Boston University
Information provided by (Responsible Party):
Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:
NCT02079766
First received: March 4, 2014
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Chronic Traumatic Encephalopathy
Drug: florbetapir F 18
Drug: 18F-AV-1451
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Avid Radiopharmaceuticals:

Primary Outcome Measures:
  • CTE Biomarker Analysis [ Time Frame: Up to 100 minutes post injection ] [ Designated as safety issue: No ]
    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.

  • Relationship Between Clinical Presentation and Tau Deposition [ Time Frame: Up to 100 minutes post injection ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 30
Study Start Date: June 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years to 69 Years
Genders 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) study protocol
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02079766

Contacts
Contact: Avid Clinical Operations 215-298-0700 clinicaloperations@avidrp.com

Locations
United States, Massachusetts
Research Site Recruiting
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Avid Radiopharmaceuticals
Boston University
Investigators
Study Chair: Chief Medical Officer Avid Radiopharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT02079766     History of Changes
Other Study ID Numbers: 18F-AV-1451-A07
Study First Received: March 4, 2014
Last Updated: July 2, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Brain Diseases
Brain Injuries
Brain Injury, Chronic
Dementia
Brain Damage, Chronic
Central Nervous System Diseases
Craniocerebral Trauma
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on November 20, 2014