Autopsy Follow-up of Subjects Previously Imaged With Florbetapir F 18 (18F-AV-45) PET in Trial 18F-AV-45-A07
NCT ID: NCT01447719
Last Updated: 2025-03-21
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
110 participants
INTERVENTIONAL
2010-03-31
2011-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
1. To expand the number of subjects included in the A07 (NCT00857415) trial correlation analysis (measuring the correlation between the global visual rating of brain amyloid plaque density on an independent blinded read of the florbetapir F 18 PET scan and the cortical amyloid plaque density at autopsy as assessed by histopathology for subjects in the autopsy cohort).
2. To determine the sensitivity and specificity of an independent blinded visual read assessment of the florbetapir F 18 PET scan (Aβ+ or Aβ-) versus the final blinded neuropathological assessment made at autopsy.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
18F-AV-1451 Autopsy Study
NCT02516046
A Study of Flortaucipir PET in Healthy Volunteers and Cognitively Impaired Subjects
NCT01992380
Follow up 18F-AV-1451 Scan in Confirmatory Cohort Subjects From Study 18F-AV-1451-A05
NCT02795780
PET Imaging Study Using [11C]PIB in Subjects With AD & Healthy Volunteers
NCT01826110
Clinical Evaluation of Flortaucipir F 18
NCT02278367
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
florbetapir F 18
No study drug administered in this trial. Study subjects previously dosed with 18F-AV-45 in study 18F-AV-45-A07 (NCT00857415) are followed to autopsy in this extension study.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Met entrance criteria and were enrolled and imaged in trial 18F-AV-45-A07 (NCT00857415)
* Gave informed consent for the 18F-AV-45-A07 (NCT00857415) study procedures and brain donation consistent with the legal requirements of the State in which they are enrolled and the State in which they die
* Consent to participate in the 18F-AV-45-A16 (NCT01447719) extension protocol, if required by the IRB
* Reconfirm their consent to a research brain autopsy, if required by the IRB.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Avid Radiopharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Phoenix, Arizona, United States
Research Site
Sun City, Arizona, United States
Research Site
Little Rock, Arkansas, United States
Research Site
Irvine, California, United States
Research Site
Fort Myers, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Miami Beach, Florida, United States
Research Site
Miami Springs, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Sarasota, Florida, United States
Research Site
St. Petersburg, Florida, United States
Research Site
West Palm Beach, Florida, United States
Research Site
Baltimore, Maryland, United States
Research Site
Hattiesburg, Mississippi, United States
Research Site
St Louis, Missouri, United States
Research Site
Albany, New York, United States
Research Site
New Hyde Park, New York, United States
Research Site
Durham, North Carolina, United States
Research Site
Centerville, Ohio, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Charleston, South Carolina, United States
Research Site
Johnson City, Tennessee, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Clark CM, Pontecorvo MJ, Beach TG, Bedell BJ, Coleman RE, Doraiswamy PM, Fleisher AS, Reiman EM, Sabbagh MN, Sadowsky CH, Schneider JA, Arora A, Carpenter AP, Flitter ML, Joshi AD, Krautkramer MJ, Lu M, Mintun MA, Skovronsky DM; AV-45-A16 Study Group. Cerebral PET with florbetapir compared with neuropathology at autopsy for detection of neuritic amyloid-beta plaques: a prospective cohort study. Lancet Neurol. 2012 Aug;11(8):669-78. doi: 10.1016/S1474-4422(12)70142-4. Epub 2012 Jun 28.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
18F-AV-45-A16
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.