Clinical trial NCT02278367: Clinical Evaluation of Flortaucipir F 18
Official title: Clinical Evaluation of 18F-AV-1451
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Traumatic Brain Injury
Depression
Lead sponsor: Avid Radiopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-10-30
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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


Eligibility criteria: 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 magnetic resonance imaging (MRI) as part of the companion study

Exclusion Criteria:

* Have clinically significant cardiac, hepatic, renal, pulmonary, metabolic, or endocrine disturbances
* Have a screening electrocardiogram with a corrected QT interval (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 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

Primary outcomes:
measure: Number of Participants With Adverse Events Related to Flortaucipir Administration
timeFrame: within 48 hours of drug administration
measure: Flortaucipir PET Scan SUVr
timeFrame: baseline and follow-up scans
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner Alzheimer's Institute
state: Arizona
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Las Vegas
country: United States
facility: Cleveland Clinic Lou Ruvo Center for Brain Health
state: Nevada
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Dallas
country: United States
facility: Center for Vital Longevity at the University of Texas at Dallas
state: Texas
Study officials:
References: