Analysis of 18F-AV-1451 PET Imaging in Cognitively Healthy, MCI, and AD Subjects
NCT ID: NCT02016560
Last Updated: 2020-09-22
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
PHASE2/PHASE3
383 participants
INTERVENTIONAL
2013-12-31
2017-07-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Observational Study of Cognitive Outcomes for Subjects Who Have Had Prior PET Amyloid Imaging With Florbetapir F 18 (18F-AV-45)
NCT00857506
A Phase II Trial of 18F-AV-45 Positron Emission Tomography (PET) Imaging in Healthy Volunteers, Patients With Mild Cognitive Impairment (MCI) and Patients With Alzheimer's Disease (AD)
NCT00702143
A Study of Two Doses of 18F-AV-45 in Alzheimer's Disease and Healthy Volunteers
NCT01565330
Imaging Characteristics of Florbetapir 18F in Patients With Frontotemporal Dementia, Alzheimer's Disease and Normal Controls.
NCT01890343
Flortaucipir PET Imaging in the Preclinical, Prodromal and Dementia Phases of Alzheimer's Disease
NCT04468347
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The second, Confirmatory Phase of the study was designed to provide independent validation of the relationships observed in the exploratory analyses of the first phase. In particular, the goal of the second phase was to confirm the relationship between flortaucipir uptake in the brain as measured by PET signals at baseline and the subsequent rate of cognitive decline observed over the 18-month longitudinal follow up.
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.
NON_RANDOMIZED
SEQUENTIAL
DIAGNOSTIC
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Exploratory Cognitively Healthy Subjects
Subjects will receive an IV injection, 370 megabecquerel (MBq) (10 millicurie \[mCi\]), single dose of florbetapir F 18 at baseline. Subjects will receive an IV injection, 370 MBq (10 mCi), single dose of flortaucipir at baseline.
florbetapir F 18
Flortaucipir F18
Brain PET Scan
positron emission tomography (PET) scan of the brain
Exploratory MCI Subjects
Subjects will receive an IV injection, 370 MBq (10 mCi), single dose of florbetapir F 18 at baseline. Subjects will receive an IV injection, 370 MBq (10 mCi), single dose of flortaucipir at baseline, 9 months and 18 months.
florbetapir F 18
Flortaucipir F18
Brain PET Scan
positron emission tomography (PET) scan of the brain
Exploratory AD Subjects
Subjects will receive an IV injection, 370 MBq (10 mCi), single dose of florbetapir F 18 at baseline. Subjects will receive an IV injection, 370 MBq (10 mCi), single dose of flortaucipir at baseline, 9 months and 18 months.
florbetapir F 18
Flortaucipir F18
Brain PET Scan
positron emission tomography (PET) scan of the brain
Confirmatory Subjects
Subjects will receive an IV injection, 370 MBq (10 mCi), single dose of florbetapir F 18 and flortaucipir at baseline.
florbetapir F 18
Flortaucipir F18
Brain PET Scan
positron emission tomography (PET) scan of the brain
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
florbetapir F 18
Flortaucipir F18
Brain PET Scan
positron emission tomography (PET) scan of the brain
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
* ≥ 20 to ≤ 40 years of age OR ≥ 50 years of age
* Mini-mental state examination (MMSE) ≥ 29
* No significant history of cognitive impairment
Exploratory MCI Subjects
* ≥ 50 years of age
* MMSE ≥ 24
* Have MCI consistent with National Institute on Aging-Alzheimer's Association (NIA-AA) working group's diagnostic guidelines for AD
* Have a study partner that can report on subject's activities of daily living
Exploratory AD Subjects
* ≥ 50 years of age
* MMSE \> 10
* Have possible or probable AD based on the NIA-AA working group's diagnostic guidelines for AD
* Have a study partner that can report on subject's activities of daily living
Confirmatory Subjects
* ≥ 50 years of age
* MMSE ≥ 20 and ≤ 27
* Cognitively impaired subjects with either MCI or dementia with a suspected neurodegenerative cause
* Have a study partner that can report on subject's activities of daily living
Exclusion Criteria
* Evidence of structural brain abnormalities
* History of moderate or severe traumatic brain injury
* Current clinically significant cardiovascular disease or ECG abnormalities, or additional risk factors for Torsades de Pointes
* Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer
* History of alcohol or substance abuse or dependence
* Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
* Have received or participated in a trial with investigational medications in the past 30 days
* Have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session.
20 Years
ALL
Yes
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.
Banner Alzheimer's Institute
Phoenix, Arizona, United States
Four Peaks Neurology
Scottsdale, Arizona, United States
Mayo Clinic
Scottsdale, Arizona, United States
Banner Sun Health Research Institute
Sun City, Arizona, United States
UC Irvine
Irvine, California, United States
Hoag Memorial
Newport Beach, California, United States
Norther California PET Imaging Center
Sacramento, California, United States
UC Davis
Sacramento, California, United States
UC San Francisco
San Francisco, California, United States
Neurological Research Institute
Santa Monica, California, United States
Molecular NeuroImaging
New Haven, Connecticut, United States
Quantum Laboratories
Deerfield Beach, Florida, United States
21st Century Oncology
Fort Myers, Florida, United States
Sandlake Imaging
Orlando, Florida, United States
Meridien Research
St. Petersburg, Florida, United States
USF Health Byrd Alzheimer's Center
Tampa, Florida, United States
Independent Imaging
West Palm Beach, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Boston University
Boston, Massachusetts, United States
Alzheimer's Disease Center
Quincy, Massachusetts, United States
Center for Clinical Imaging Research
St Louis, Missouri, United States
Las Vegas Radiology
Las Vegas, Nevada, United States
Center for Brain Health - NYU Langone Medical Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Butler Hospital
Providence, Rhode Island, 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.
Lu M, Pontecorvo MJ, Devous MD Sr, Arora AK, Galante N, McGeehan A, Devadanam C, Salloway SP, Doraiswamy PM, Curtis C, Truocchio SP, Flitter M, Locascio T, Devine M, Zimmer JA, Fleisher AS, Mintun MA; AVID Collaborators. Aggregated Tau Measured by Visual Interpretation of Flortaucipir Positron Emission Tomography and the Associated Risk of Clinical Progression of Mild Cognitive Impairment and Alzheimer Disease: Results From 2 Phase III Clinical Trials. JAMA Neurol. 2021 Apr 1;78(4):445-453. doi: 10.1001/jamaneurol.2020.5505.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan: Confirmatory Phase SAP
Document Type: Statistical Analysis Plan: Confirmatory Phase Addendum SAP
Document Type: Statistical Analysis Plan: Exploratory Phase SAP
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
18F-AV-1451-A05
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.