Status:
COMPLETED
Amyloid and Tauopathy PET Imaging in Acute and Chronic Traumatic Brain Injury
Lead Sponsor:
Samuel Gandy
Conditions:
Traumatic Brain Injury
Chronic Traumatic Encephalopathy
Eligibility:
MALE
40-85 years
Brief Summary
The potential long-term effects of Traumatic Brain Injury (TBI) are poorly understood. Repeated concussions have been associated with an elevated incidence of Alzheimer's disease (AD) along with a red...
Detailed Description
The study involves two days of study visits. Subjects will be given a copy of the consent form on the morning of their first visit, and sign consent in a private room at Mount Sinai before any researc...
Eligibility Criteria
Inclusion
- males between 40 to 85 years of age
- individuals who participated in contact sports (e.g., active and retired NFL players, NHL players, boxers, NCAA athletes) and other individuals (including but not limited to veterans, breachers, or law enforcement officials with multiple blast exposures) who all have a history of one or more concussions and have a memory or cognitive complaint
- individuals with Mild Cognitive Impairment (MCI) and no history of concussion or TBI
- healthy controls with no history of head injury and no current cognitive or memory problems
- all participants require a study partner, who is well acquainted with the participant, to answer questions either in person or over the telephone about the individuals' activities of daily living, and to corroborate cognitive problems and past history of brain injury
Exclusion
- any significant neurological disease, such as Alzheimer's disease, Parkinson's disease, vascular dementia, Huntington's disease, Pick's disease, Lewy Body Dementia, frontotemporal dementia, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, or multiple sclerosis
- any significant systemic illness or unstable medical condition, including: uncontrolled diabetes mellitus, uncorrected hypothyroidism or hyperthyroidism, or systemic cancer
- a history of schizophrenia or psychosis, alcohol or substance abuse or dependence within the past 6 months
- clinically significant impairment of liver or renal function
- significant cerebrovascular disease
- impairment of visual or auditory acuity sufficient to interfere with completion of study procedures
- education level \< 10 years
- any subjects with a history of risk factors for Torsades de Pointes, or subjects taking drugs known to prolong the QT interval
- subjects who have had 2 or more PET scans within the past year, or other significant exposure to radiation (i.e., radiation therapy)
Key Trial Info
Start Date :
January 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 21 2017
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT02266563
Start Date
January 1 2015
End Date
December 21 2017
Last Update
May 2 2019
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029