NCT02051790

Brief Summary

This study is designed to evaluate the agreement between florbetapir F 18 scan interpretation in the clinic and by expert readers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
241

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 31, 2014

Completed
29 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

September 28, 2015

Completed
Last Updated

September 28, 2015

Status Verified

August 1, 2015

Enrollment Period

5 months

First QC Date

January 30, 2014

Results QC Date

August 3, 2015

Last Update Submit

August 27, 2015

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

  • Agreement Between Expert Panel and Clinical Practice Reads

    Agreement between expert panel consensus scan interpretations and clinical practice reader scan interpretations was calculated as a weighted Kappa value across all cases and all clinical practice readers.

    Scan acquired 50-60 minutes post injection

Study Arms (1)

Clinical Practice Scans

EXPERIMENTAL

Approximately 250 florbetapir F 18 scans and final scan reports interpreted in a clinical setting will be collected from physicians across the country. These results will then be compared to expert panel interpretations for the same scans.

Drug: florbetapir F 18

Interventions

florbetapir F 18DRUG

No study drug will be administered in this study - scans previously acquired in the course of clinical practice.

Also known as: 18F-AV-45, Amyvid, florbetapir
Clinical Practice Scans

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \- Scan obtained for clinical reasons

You may not qualify if:

  • \- None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

florbetapir

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Chief Medical Officer
Organization
Avid Radiopharmaceuticals
clinicaloperations@avidrp.com
215-298-0700

Study Officials

  • Chief Medical Officer

    Avid Radiopharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2014

First Posted

January 31, 2014

Study Start

March 1, 2014

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

September 28, 2015

Results First Posted

September 28, 2015

Record last verified: 2015-08

Locations

US(1)