Trial Outcomes & Findings for Clinical Evaluation of Florbetapir F 18 (18F-AV-45) (NCT NCT01518374)

Last Updated: 2018-07-18

Results Overview

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)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

1768 participants

Primary outcome timeframe

48 hours

Results posted on

2018-07-18

Participant Flow

All enrolled subjects who received an injection of florbetapir and completed safety assessment were considered to have completed the study.

This was a standardized imaging protocol designed to support companion studies where amyloid imaging was used as a biomarker in longitudinal studies of aging or studies of biomarkers for neurodegenerative diseases. Subjects had to meet additional inclusion/exclusion criteria for the companion protocol before being injected and imaged under A14.

Participant milestones

Participant milestones
Measure	Florbetapir-PET Scans Florbetapir F 18: 370 MBq (10 mCi)
Overall Study STARTED	1768
Overall Study COMPLETED	1761
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Florbetapir-PET Scans Florbetapir F 18: 370 MBq (10 mCi)
Overall Study Withdrawal by Subject	2
Overall Study Protocol Violation	3
Overall Study Lost to Follow-up	2

Baseline Characteristics

6 participants did not have baseline age in the database

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Florbetapir-PET Scans n=1768 Participants Florbetapir F 18: 370 MBq (10 mCi)
Age, Continuous	68.3 years STANDARD_DEVIATION 13.43 • n=1762 Participants • 6 participants did not have baseline age in the database
Sex: Female, Male Female	920 Participants n=1768 Participants
Sex: Female, Male Male	848 Participants n=1768 Participants
Race (NIH/OMB) American Indian or Alaska Native	7 Participants n=1768 Participants
Race (NIH/OMB) Asian	28 Participants n=1768 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=1768 Participants
Race (NIH/OMB) Black or African American	233 Participants n=1768 Participants
Race (NIH/OMB) White	1487 Participants n=1768 Participants
Race (NIH/OMB) More than one race	0 Participants n=1768 Participants
Race (NIH/OMB) Unknown or Not Reported	13 Participants n=1768 Participants
Region of Enrollment United States	1768 Participants n=1768 Participants

PRIMARY outcome

Timeframe: 48 hours

Outcome measures

Outcome measures
Measure	Florbetapir-PET Scans n=1768 Participants Florbetapir F 18: 370 MBq (10 mCi)
Number of Participants Experiencing Treatment-emergent Adverse Events Considered Related to Florbetapir Administration Headache	21 Participants
Number of Participants Experiencing Treatment-emergent Adverse Events Considered Related to Florbetapir Administration Injection site pain	6 Participants
Number of Participants Experiencing Treatment-emergent Adverse Events Considered Related to Florbetapir Administration Dizziness	5 Participants
Number of Participants Experiencing Treatment-emergent Adverse Events Considered Related to Florbetapir Administration Nausea	5 Participants
Number of Participants Experiencing Treatment-emergent Adverse Events Considered Related to Florbetapir Administration Fatigue	4 Participants
Number of Participants Experiencing Treatment-emergent Adverse Events Considered Related to Florbetapir Administration Back pain	4 Participants
Number of Participants Experiencing Treatment-emergent Adverse Events Considered Related to Florbetapir Administration Dry mouth	4 Participants

Adverse Events

Florbetapir-PET Scans

Serious events: 1 serious events

Other events: 111 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Florbetapir-PET Scans n=1768 participants at risk Florbetapir F 18: 370 MBq (10 mCi)
Nervous system disorders Ischaemic stroke	0.06% 1/1768 • Within 48 hours of florbetapir injection Note: adverse events results differ from results reported above because this section reports ALL adverse events, regardless of relatedness designation by the investigator.

Other adverse events

Other adverse events
Measure	Florbetapir-PET Scans n=1768 participants at risk Florbetapir F 18: 370 MBq (10 mCi)
Nervous system disorders Headache	2.7% 47/1768 • Within 48 hours of florbetapir injection Note: adverse events results differ from results reported above because this section reports ALL adverse events, regardless of relatedness designation by the investigator.
Gastrointestinal disorders Nausea	0.79% 14/1768 • Within 48 hours of florbetapir injection Note: adverse events results differ from results reported above because this section reports ALL adverse events, regardless of relatedness designation by the investigator.
General disorders Fatigue	0.68% 12/1768 • Within 48 hours of florbetapir injection Note: adverse events results differ from results reported above because this section reports ALL adverse events, regardless of relatedness designation by the investigator.
Nervous system disorders Dizziness	0.57% 10/1768 • Within 48 hours of florbetapir injection Note: adverse events results differ from results reported above because this section reports ALL adverse events, regardless of relatedness designation by the investigator.
Musculoskeletal and connective tissue disorders Back pain	0.62% 11/1768 • Within 48 hours of florbetapir injection Note: adverse events results differ from results reported above because this section reports ALL adverse events, regardless of relatedness designation by the investigator.
General disorders Injection site pain	0.45% 8/1768 • Within 48 hours of florbetapir injection Note: adverse events results differ from results reported above because this section reports ALL adverse events, regardless of relatedness designation by the investigator.
Gastrointestinal disorders Dry mouth	0.51% 9/1768 • Within 48 hours of florbetapir injection Note: adverse events results differ from results reported above because this section reports ALL adverse events, regardless of relatedness designation by the investigator.

Additional Information

Chief Medical Officer

Avid Radiopharmaceuticals, Inc.

Phone: 215-298-0700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60