Clinical trial NCT02516046: 18F-AV-1451 Autopsy Study
Official title: A Clinico-Pathological Study of the Correspondence Between 18F-AV-1451 PET Imaging and Post-Mortem Assessment of Tau Pathology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alzheimer's Disease
Lead sponsor: Avid Radiopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-08-05
Enrollment: 156
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is designed to test the relationship between ante-mortem flortaucipir Positron Emission Tomography (PET) imaging and tau neurofibrillary pathology associated with Alzheimer's disease (AD), as measured at autopsy.


Eligibility criteria: Inclusion Criteria:

* Have a projected life expectancy of ≤ 6 months
* 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:

* Aggressively being treated with life sustaining measures
* 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

Primary outcomes:
measure: Primary Outcome 1: Diagnostic Performance of Individual Readers (NFT Score)
timeFrame: at autopsy within 9 months of baseline scan
measure: Primary Outcome 2: Diagnostic Performance of Individual Readers (NIA-AA Autopsy Diagnosis)
timeFrame: at autopsy within 9 months of baseline scan
Secondary outcomes:
measure: Flortaucipir Diagnostic Performance (NFT Score)
timeFrame: at autopsy within 9 months of baseline scan
measure: Flortaucipir Diagnostic Performance (NIA-AA Autopsy Diagnosis)
timeFrame: at autopsy within 9 months of baseline scan
measure: Inter-Reader Agreement
timeFrame: baseline scan
Other outcomes:
measure: Diagnostic Performance of Individual Readers (NFT Score B2-B3 as Truth Positive)
timeFrame: at autopsy within 9 months of baseline scan
Locations:
city: Phoenix
country: United States
facility: Banner Alzheimer's Institute
state: Arizona
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center
state: Arizona
city: Los Gatos
country: United States
facility: Cherlin Research
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
city: San Diego
country: United States
facility: California Research Foundation
state: California
city: San Diego
country: United States
facility: Pacific Research Network
state: California
city: San Francisco
country: United States
facility: Ray Dolby Brain Health Center
state: California
city: Santa Ana
country: United States
facility: Syrentis Clinical Research
state: California
city: Fort Myers
country: United States
facility: Neuropsychiatric Research Center of Southwest Florida
state: Florida
city: Hialeah
country: United States
facility: Galiz Research
state: Florida
city: Merritt Island
country: United States
facility: Merritt Island Medical Research
state: Florida
city: Miami
country: United States
facility: Miami Jewish Health Systems
state: Florida
city: Miami
country: United States
facility: D de la Vega MD Research Group
state: Florida
city: Orlando
country: United States
facility: Bioclinica
state: Florida
city: Atlanta
country: United States
facility: Emory University Brain Health Center
state: Georgia
city: Quincy
country: United States
facility: Alzheimer's Disease Center
state: Massachusetts
city: Henderson
country: United States
facility: Steinberg Diagnostics
state: Nevada
city: Glens Falls
country: United States
facility: Adirondack Medical Research Center
state: New York
city: Syracuse
country: United States
facility: Clarity Clinical Research, LLC
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest School of Medicine
state: North Carolina
city: Centerville
country: United States
facility: Valley Medical Primary Care
state: Ohio
city: Cleveland
country: United States
facility: Hospice of the Western Reserve
state: Ohio
city: Oklahoma City
country: United States
facility: American Clinical Trials, LLC (Site 1216)
state: Oklahoma
city: Oklahoma City
country: United States
facility: Oklahoma Behavioral Health
state: Oklahoma
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Houston
country: United States
facility: Houston Methodist Research Institute
state: Texas
city: Kerrville
country: United States
facility: Sante Clinical Research
state: Texas
city: Bellevue
country: United States
facility: Overlake Internal Medicine Associates, PS
state: Washington
city: Seattle
country: United States
facility: University of Washington Medicine
state: Washington
city: Parkville
country: Australia
facility: University of Melbourne
state: Victoria
Study officials:
affiliation: Avid Radiopharmaceuticals, Inc.
name: Chief Medical Officer
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.