A Study of 18F-AV-45 in Healthy Volunteers

NCT ID: NCT01564706

Last Updated: 2012-05-18

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-01-31

Brief Summary

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

This study will determine how florbetapir F 18 (18F-AV-45) radioactivity is distributed throughout the body.

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 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.

Healthy Volunteers

Healthy male or female subjects, between 18 and 85 years of age.

Group Type EXPERIMENTAL

florbetapir F 18

Intervention Type DRUG

IV injection, 370MBq (10mCi), single dose

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

florbetapir F 18

IV injection, 370MBq (10mCi), single dose

Intervention Type DRUG

Other Intervention Names

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

18F-AV-45 Amyvid florbetapir

Eligibility Criteria

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

Inclusion Criteria

* Able to lie still on the imaging table for periods up to 1 hour

Exclusion Criteria

* Radiation exposure for experimental purposes within the last year
* Claustrophobic or otherwise unable to tolerate the imaging procedure
* Medical condition or surgical history that would confound evaluation
* Current clinically significant cardiovascular disease
* Received an investigational medication within the last 30 days
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 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_DIRECTOR

Avid Radiopharmaceuticals

Locations

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

Research Site

Jenkintown, Pennsylvania, 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-45-A02

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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

Evaluation of Reader Training Processes
NCT02051790 COMPLETED PHASE4