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

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)

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (23): Northwestern University
🇺🇸
Chicago, Illinois, United States
Johns Hopkins University
🇺🇸
Baltimore, Maryland, United States
University of Kansas
🇺🇸
Kansas City, Kansas, United States
University of Tennessee
🇺🇸
Knoxville, Tennessee, United States
University of Mississippi Medical Center
🇺🇸
Jackson, Mississippi, United States
Washington University School of Medicine
🇺🇸
Saint Louis, Missouri, United States
Banner Sun Health Research Institute
🇺🇸
Sun City, Arizona, United States
Banner Health
🇺🇸
Phoenix, Arizona, United States
UC Irvine
🇺🇸
Orange, California, United States
UC Davis
🇺🇸
Davis, 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
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
Duke University
🇺🇸
Durham, North Carolina, United States
Jefferson
🇺🇸
Philadelphia, Pennsylvania, United States
Wake Forest University
🇺🇸
Winston-Salem, North Carolina, United States
University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
Butler Hospital
🇺🇸
Providence, Rhode Island, United States
UTSW
🇺🇸
Dallas, Texas, United States
Vanderbilt
🇺🇸
Nashville, Tennessee, United States
University of Southern California
🇺🇸
Los Angeles, California, United States