Flortaucipir 18F PET Imaging in BIOCARD Study

NCT03052972 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: 18F-AV-1451-A20
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cognitive Decline

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Amyloid Positive

EXPERIMENTAL

Clinically normal amyloid positive subjects from BIOCARD study receiving a flortaucipir PET scan

Drug: Flortaucipir F18; Procedure: Brain PET scan

Amyloid Negative

EXPERIMENTAL

Clinically normal amyloid negative subjects from BIOCARD study receiving a flortaucipir PET scan

Drug: Flortaucipir F18; Procedure: Brain PET scan

Interventions

Flortaucipir F18 DRUG

370 megabecquerel (MBq)(10 millicurie \[mCi\]) single dose

Also known as: 18F-AV-1451, [F-18]T807, LY3191748, Tauvid

Amyloid Negative; Amyloid Positive

Brain PET scan PROCEDURE

positron emission tomography (PET) scan of the brain

Amyloid Negative; Amyloid Positive

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Avid Radiopharmaceuticals: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

Location

Related Links

• BIOCARD Study Summary

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Limitations and Caveats

Due to slower than expected enrollment, the study was terminated before 100 subjects were recruited.

Results Point of Contact

• Title: Medical Director
• Organization: Avid Radiopharmaceuticals, Inc.

clinicaloperations@avidrp.com

215-298-0700

Study Officials

• Medical Director

  Avid Radiopharmaceuticals, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2017
• First Posted: February 14, 2017
• Study Start: March 23, 2017
• Primary Completion: August 14, 2018
• Study Completion: August 17, 2018
• Last Updated: September 25, 2020
• Results First Posted: August 13, 2020

Record last verified: 2020-09

Locations

US (1)