Clinical Evaluation of 18F-AV-1451



Status:Recruiting
Conditions:Alzheimer Disease, Depression, Neurology
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:1/11/2019
Start Date:December 2014
End Date:April 2019
Contact:Avid Clinical Operations
Email:clinicaloperations@avidrp.com
Phone:215-298-0700

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This study is designed to expand the database of 18F-AV-1451 safety and tau binding as
measured by PET imaging and to provide standardized conditions for 18F-AV-1451 use, data
collection and analysis to facilitate companion studies including, but not limited to,
longitudinal studies of aging, depression, and traumatic brain injury.


Subjects should meet inclusion and exclusion criteria for the companion protocol in
addition to the criteria below.

Inclusion Criteria:

- Subjects who have a historical volumetric MRI as part of the companion study

Exclusion Criteria:

- Have clinically significant cardiac, hepatic, renal, pulmonary, metabolic, or
endocrine disturbances

- Have a screening ECG with QTc > 450 msec if male or QTc > 470 msec if female

- Have a history of additional risk factors for Torsades de Pointes (TdP) or are taking
drugs known to cause QT-prolongation. Patients with a prolonged QTc interval in the
setting of intraventricular conduction block may be enrolled with sponsor approval

- Have a history of drug or alcohol dependence within the last year, or prior prolonged
history of dependence unless approved by the sponsor

- Are females of childbearing potential who are not surgically sterile, not refraining
from sexual activity or not using reliable methods of contraception

- Have a history of relevant severe drug allergy or hypersensitivity

- Are patients who have received an investigational medication under an FDA IND protocol
within 30 days prior to the planned imaging session for this study

- Are patients with current clinically significant unstable medical comorbidities

- Are patients who have received a radiopharmaceutical for imaging or therapy within the
past 24 hours prior to the imaging session for this study
We found this trial at
5
sites
New Haven, Connecticut 6520
(203) 432-4771
Principal Investigator: Christopher van Dyck
Phone: 203-764-8100
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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Dallas, Texas 75235
Principal Investigator: Denise Park, Ph.D.
Phone: 972-883-3701
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Las Vegas, Nevada 89106
Principal Investigator: Jeffrey Cummings
Phone: 702-483-6205
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Phoenix, Arizona 85006
Principal Investigator: Eric Reiman, MD
Phone: 602-839-2033
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