Flortaucipir 18F PET Imaging in BIOCARD Study

Cognitive Decline Clinical Trial

Official title:

Flortaucipir (18F) PET Imaging in the BIOCARD Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03052972
• Other study ID #: 18F-AV-1451-A20
• Status: Terminated
• Phase: Phase 1
• Start date: March 23, 2017
• Est. completion date: August 17, 2018

Study information

• Verified date: September 2020
• Source: Avid Radiopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to assess the imaging characteristics of Flortaucipir (18F-AV-1451) in subjects who participated in the Biomarkers of Cognitive Decline Among Normal Individuals (BIOCARD) study at Johns Hopkins University.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: August 17, 2018
• Est. primary completion date: August 14, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Males or females that have provided consent and are currently enrolled in BIOCARD study

• Ability to tolerate PET scan procedures

• Ability to provide informed consent for study procedures

Exclusion Criteria:

• Has condition(s) that could augment risk to participant or compromise ability to tolerate experimental procedures or interfere with analysis of the study data as determined by the investigator

• Has a history of risk factors for Torsades de Pointes or taking medications known to cause QT prolongation.

• Has electrocardiogram acquired prior to initial flortaucipir scan that clinically contradicts subject's participation in the study as determined by the investigator. Bazett's corrected QT (QTcB) interval must be assessed and not exceed accepted values (458 msec in males, 474 msec in females).

• Females of childbearing potential who are not surgically sterile, not refraining from sexual activity, or not using reliable contraceptive methods.

• Has hypersensitivity to flortaucipir

• Has a currently clinically significant infectious disease, endocrine/metabolic disease, pulmonary/renal/hepatic impairment, or cancer that could impact study participation or scan results in the opinion of the investigator.

• Has a non-study related radiopharmaceutical imaging/treatment procedure within seven days prior to flortaucipir imaging visit.

• Is unsuitable for a study of this type in the opinion of the investigator.

Related Conditions & MeSH terms

• Cognitive Decline
• Cognitive Dysfunction

Intervention

Drug:
• Flortaucipir F18
370 megabecquerel (MBq)(10 millicurie [mCi]) single dose

Procedure:
• Brain PET scan
positron emission tomography (PET) scan of the brain

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Avid Radiopharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Qualitative Evaluation of Scan Results	Subject scans were visually evaluated by an expert reader into three groups. Advanced Alzheimer's disease (AD) scan pattern = In either hemisphere, increased neocortical activity in the parietal/precuneus region(s), or frontal region(s) with increased uptake in the posterolateral temporal (PLT), parietal, or occipital region(s). Moderate AD scan pattern = In either hemisphere, increased neocortical activity limited to the PLT or occipital region(s). Not AD scan pattern = No increased neocortical activity, or increased neocortical activity isolated to the mesial temporal, anterolateral temporal, and/or frontal regions.	Baseline scan
Primary	Quantitative Evaluation of Scan Results	Standard Uptake Value Ratio (SUVr) by amyloid status using a weighted cortical average. For SUVr, a value of 1 or lower signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.	75 minutes post dose administration

External Links

•   BIOCARD Study Summary