Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
156 participants
INTERVENTIONAL
2015-09-30
2018-07-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Flortaucipir PET Scan
Flortaucipir F18
370 megabecquerel (MBq) IV single-dose
PET Scan
positron emission tomography (PET) scan
Interventions
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Flortaucipir F18
370 megabecquerel (MBq) IV single-dose
PET Scan
positron emission tomography (PET) scan
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Can tolerate a 20 minute PET scan
* Give informed consent or have a legally authorized representative to consent for study procedures and brain donation consistent with the legal requirements of the State in which they die
Exclusion Criteria
* Known to have a structural brain lesion that would interfere either with PET imaging or pathological assessment
* Clinically significant infectious disease
* Currently receiving any investigational medications except with permission from the study sponsor
* Participated in an experimental study with an amyloid or tau targeting agent
* Suspected encephalopathy due to alcoholism or end-stage liver disease
* Females of childbearing potential
* History of risk factors for Torsades de Pointes or are currently taking medication known to cause QT prolongation
50 Years
ALL
No
Sponsors
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Avid Radiopharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Chief Medical Officer
Role: STUDY_CHAIR
Avid Radiopharmaceuticals, Inc.
Locations
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Banner Alzheimer's Institute
Phoenix, Arizona, United States
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
Cherlin Research
Los Gatos, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
California Research Foundation
San Diego, California, United States
Pacific Research Network
San Diego, California, United States
Ray Dolby Brain Health Center
San Francisco, California, United States
Syrentis Clinical Research
Santa Ana, California, United States
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, United States
Galiz Research
Hialeah, Florida, United States
Merritt Island Medical Research
Merritt Island, Florida, United States
Miami Jewish Health Systems
Miami, Florida, United States
D de la Vega MD Research Group
Miami, Florida, United States
Bioclinica
Orlando, Florida, United States
Emory University Brain Health Center
Atlanta, Georgia, United States
Alzheimer's Disease Center
Quincy, Massachusetts, United States
Steinberg Diagnostics
Henderson, Nevada, United States
Adirondack Medical Research Center
Glens Falls, New York, United States
Clarity Clinical Research, LLC
Syracuse, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States
Valley Medical Primary Care
Centerville, Ohio, United States
Hospice of the Western Reserve
Cleveland, Ohio, United States
American Clinical Trials, LLC (Site 1216)
Oklahoma City, Oklahoma, United States
Oklahoma Behavioral Health
Oklahoma City, Oklahoma, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Houston Methodist Research Institute
Houston, Texas, United States
Sante Clinical Research
Kerrville, Texas, United States
Overlake Internal Medicine Associates, PS
Bellevue, Washington, United States
University of Washington Medicine
Seattle, Washington, United States
University of Melbourne
Parkville, Victoria, Australia
Countries
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References
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Hyman BT, Phelps CH, Beach TG, Bigio EH, Cairns NJ, Carrillo MC, Dickson DW, Duyckaerts C, Frosch MP, Masliah E, Mirra SS, Nelson PT, Schneider JA, Thal DR, Thies B, Trojanowski JQ, Vinters HV, Montine TJ. National Institute on Aging-Alzheimer's Association guidelines for the neuropathologic assessment of Alzheimer's disease. Alzheimers Dement. 2012 Jan;8(1):1-13. doi: 10.1016/j.jalz.2011.10.007.
Montine TJ, Phelps CH, Beach TG, Bigio EH, Cairns NJ, Dickson DW, Duyckaerts C, Frosch MP, Masliah E, Mirra SS, Nelson PT, Schneider JA, Thal DR, Trojanowski JQ, Vinters HV, Hyman BT; National Institute on Aging; Alzheimer's Association. National Institute on Aging-Alzheimer's Association guidelines for the neuropathologic assessment of Alzheimer's disease: a practical approach. Acta Neuropathol. 2012 Jan;123(1):1-11. doi: 10.1007/s00401-011-0910-3. Epub 2011 Nov 20.
Fleisher AS, Pontecorvo MJ, Devous MD Sr, Lu M, Arora AK, Truocchio SP, Aldea P, Flitter M, Locascio T, Devine M, Siderowf A, Beach TG, Montine TJ, Serrano GE, Curtis C, Perrin A, Salloway S, Daniel M, Wellman C, Joshi AD, Irwin DJ, Lowe VJ, Seeley WW, Ikonomovic MD, Masdeu JC, Kennedy I, Harris T, Navitsky M, Southekal S, Mintun MA; A16 Study Investigators. Positron Emission Tomography Imaging With [18F]flortaucipir and Postmortem Assessment of Alzheimer Disease Neuropathologic Changes. JAMA Neurol. 2020 Jul 1;77(7):829-839. doi: 10.1001/jamaneurol.2020.0528.
Pontecorvo MJ, Keene CD, Beach TG, Montine TJ, Arora AK, Devous MD Sr, Navitsky M, Kennedy I, Joshi AD, Lu M, Serrano GE, Sue LI, Intorcia AJ, Rose SE, Wilson A, Hellstern L, Coleman N, Flitter M, Aldea P, Fleisher AS, Mintun MA, Siderowf A. Comparison of regional flortaucipir PET with quantitative tau immunohistochemistry in three subjects with Alzheimer's disease pathology: a clinicopathological study. EJNMMI Res. 2020 Jun 15;10(1):65. doi: 10.1186/s13550-020-00653-x.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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18F-AV-1451-A16
Identifier Type: -
Identifier Source: org_study_id
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