Trial Outcomes & Findings for Evaluation of PET Scan Timing Relative to AV-45 Injection Time (NCT NCT01565356)

Results Overview

Three independent readers blinded to subject identification, subject diagnosis, subject demographics and PET scan time points post-injection read each scan and reported as amyloid positive or amyloid negative. Results show the percentage of agreement between the majority read of 30-40 min scan and the majority read of the 50-60 min scan.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

41 participants

Primary outcome timeframe

Scans acquired 30-40 min and 50-60 min after injection

Results posted on

2012-06-07

Participant Flow

NO SUBJECTS WERE ENROLLED IN THIS STUDY - this study re-read scans obtained in other clinical studies

Participant milestones

Participant milestones
Measure	All Subject Scans 22 florbetapir-PET scans obtained in Study A01 and and 19 scans obtained in A03
Overall Study STARTED	41
Overall Study COMPLETED	41
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of PET Scan Timing Relative to AV-45 Injection Time

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Subject Scans n=41 Participants 22 florbetapir-PET scans obtained in Study A01 and and 19 scans obtained in A03
Age Continuous	65.49 years STANDARD_DEVIATION 15.302 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants
Region of Enrollment United States	41 participants n=5 Participants

PRIMARY outcome

Timeframe: Scans acquired 30-40 min and 50-60 min after injection

Three independent readers blinded to subject identification, subject diagnosis, subject demographics and PET scan time points post-injection read each scan and reported as amyloid positive or amyloid negative. Results show the percentage of agreement between the majority read of 30-40 min scan and the majority read of the 50-60 min scan.

Outcome measures

Outcome measures
Measure	All Scans n=41 Participants 22 florbetapir-PET scans obtained in Study A01(NCT01565291) and and 19 scans obtained in A03(NCT01565330)
Percent Agreement of Interpretation Between 30-40 and 50-60 Min Reads - Qualitative Evaluation	100 percentage of agreement

SECONDARY outcome

Timeframe: Scans acquired 30-40 min and 50-60 min post-injection

Three independent readers blinded to subject identification, subject diagnosis, subject demographics and PET scan time points post-injection read each scan and reported the results using a 5-point scale (0=no amyloid; 4=high levels of amyloid deposition). Results are reported as a weighted kappa statistic.

Outcome measures

Outcome measures
Measure	All Scans n=41 Participants 22 florbetapir-PET scans obtained in Study A01(NCT01565291) and and 19 scans obtained in A03(NCT01565330)
Agreement of Interpretation Between 30-40 and 50-60 Min Reads - Semi-quantitative Evaluation	0.946 weighted kappa Interval 0.906 to 0.987

Adverse Events

All Subject Scans

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Chief Medical Officer

Avid Radiopharmaceuticals

Phone: 215-298-0700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60