An Open Label, Multicenter Study, Evaluating the Imaging Characteristics of a Follow-up 18F-AV-1451 Scan in Subjects Who Have Had a Prior 18F-AV-1451 Scan

Avid Radiopharmaceuticals4 sites in 1 country44 target enrollmentMay 2014

ConditionsAlzheimer's Disease

InterventionsFlortaucipir F18 Florbetapir F 18 Brain PET Scan

DrugsFlortaucipir F18 Florbetapir F 18

Overview

Phase: Phase 2
Intervention: Flortaucipir F18
Conditions: Alzheimer's Disease
Sponsor: Avid Radiopharmaceuticals
Enrollment: 44
Locations: 4
Primary Endpoint: Change in Tau Deposition
Status: Terminated
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study will evaluate the imaging characteristics of flortaucipir in subjects with a previous flortaucipir scan in order to assess the rate of change of tau deposition over time.

Registry

clinicaltrials.gov

Start Date

May 2014

End Date

December 2016

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Avid Radiopharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Have a previous 18F-AV-1451 brain scan
•Can tolerate up to two Positron Emission Tomography (PET) imaging sessions and a Magnetic Resonance Imaging (MRI) scan
•Ability to provide informed consent

Exclusion Criteria

•Current clinically significant psychiatric disease
•Are claustrophobic
•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
•Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
•Have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session

Arms & Interventions

Follow-up Flortaucipir PET Scan

Intervention: Flortaucipir F18

Follow-up Flortaucipir PET Scan

Intervention: Florbetapir F 18

Follow-up Flortaucipir PET Scan

Intervention: Brain PET Scan

Outcomes

Primary Outcomes

Change in Tau Deposition

Time Frame: baseline scan and at least 6 months after baseline scan

Rate of tau deposition change as measured by flortaucipir standardized uptake value ratio (SUVr). For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.