Imaging Characteristics of a Follow-up 18F-AV-1451 Scan

NCT ID: NCT02051764

Last Updated: 2020-09-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alzheimer's Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Follow-up Flortaucipir PET Scan

Group Type EXPERIMENTAL

Flortaucipir F18

Intervention Type DRUG

370 megabecquerel (MBq) IV single-dose

Florbetapir F 18

Intervention Type DRUG

370 megabecquerel (MBq) IV single-dose

Brain PET Scan

Intervention Type PROCEDURE

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.

Flortaucipir F18

370 megabecquerel (MBq) IV single-dose

Intervention Type DRUG

Florbetapir F 18

370 megabecquerel (MBq) IV single-dose

Intervention Type DRUG

Brain PET Scan

positron emission tomography (PET) scan of the brain

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

18F-AV-1451 LY3191748 [F-18]T807 Amyvid 18F-AV-45

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Avid Radiopharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Chief Medical Officer

Role: STUDY_CHAIR

Avid Radiopharmaceuticals, Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hoag Memorial Hospital

Newport Beach, California, United States

Site Status

UC Irvine Medical Center

Orange, California, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Center for Clinical Imaging Research, Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

18F-AV-1451-A04

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

PET and MRI Imaging of Brain Tumors Using [18F]PARPi
NCT04173104 ACTIVE_NOT_RECRUITING EARLY_PHASE1
Pilot Study of 18F-FLT PET
NCT00585741 TERMINATED NA
A PET Study in Healthy Volunteers
NCT01424449 COMPLETED PHASE1
18F-FluorThanatrace (PET/CT) in Glioblastoma
NCT04221061 TERMINATED EARLY_PHASE1