Clinical Evaluation of Florbetapir F 18 (18F-AV-45)

Phase 2

Completed

• Conditions: Alzheimer Disease; Mild Cognitive Impairment; Neurodegenerative Diseases
• Interventions: Drug: Florbetapir F 18

• Registration Number: NCT01518374
• Lead Sponsor: Avid Radiopharmaceuticals

Brief Summary

This protocol is designed to standardize imaging studies using florbetapir F 18 PET to provide information on amyloid burden in subjects participating in other studies (companion protocol) such as longitudinal studies of aging and studies of biomarkers for neurodegenerative diseases.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2011-07-20
• Study First Submitted QC: 2012-01-23
• Study First Posted: 2012-01-26
• Primary Completion: 2017-05-03
• Study Completion: 2017-05-03
• Results First Submitted: 2018-05-16
• Results First Submitted QC: 2018-05-16
• Status Verified: 2018-06
• Results First Posted: 2018-06-14
• Last Update Submitted: 2018-06-22
• Last Update Posted: 2018-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1768

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Florbetapir-PET Scans	Florbetapir F 18	-

Primary Outcome Measures

Name	Time	Method
Number of Participants Experiencing Treatment-emergent Adverse Events Considered Related to Florbetapir Administration	48 hours	Frequency of treatment-emergent adverse events considered related to florbetapir administration by the study investigator. Related events with a frequency \> 0.2% are reported.; (note: all treatment-emergent adverse events, regardless of relatedness designation, are reported in "Adverse Events" section below)

Trial Locations

Locations (23)

Banner Health; 🇺🇸 Phoenix, Arizona, United States

Banner Sun Health Research Institute; 🇺🇸 Sun City, Arizona, United States

UC Davis; 🇺🇸 Davis, California, United States

UC Irvine; 🇺🇸 Orange, California, United States

University of Southern California; 🇺🇸 Los Angeles, California, United States

UC San Francisco; 🇺🇸 San Francisco, California, United States

UC San Francisco Memory Center; 🇺🇸 San Francisco, California, United States

Mayo Clinic Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Mt. Sinai Medical Center; 🇺🇸 Miami Beach, Florida, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

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