Florbetapir Calibration to the Centiloid Scale

January 20, 2017 updated by: Avid Radiopharmaceuticals

A Multicenter, Multicountry Study to Calibrate Florbetapir (18F) PET Imaging Data to the Centiloid Scale Based on 11C-PiB

This study is designed to demonstrate the conversion of florbetapir (18F) Positron Emission Tomography (PET) Standard Uptake Value ratio (SUVr) to Centiloid units.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Research Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Cognitively Normal Subjects

    • Males or females ≥ 21 and ≤ 45 years of age
    • Mini-mental state examination (MMSE) ≥ 29
  • Clinically Diagnosed AD Subject

    • Males or females ≥ 50 years of age
    • Meet clinical criteria for dementia due to probable AD
    • MMSE ≥ 16 and ≤ 26
  • Possible AD Subject

    • Males or females ≥ 50 years of age
    • Meet clinical criteria for dementia due to possible AD
    • MMSE ≥ 16 and ≤ 26
  • MCI Subject

    • Males or females ≥ 60 years of age with cognitive impairment (not dementia)
    • MMSE >24 and <29
  • At Risk Elderly Subject

    • Cognitively normal males or females that are known ApoE4 carriers and ≥ 75 years of age
    • MMSE ≥ 27

Exclusion Criteria:

  • Have had or currently have a diagnosis of neurodegenerative disorders other than AD
  • Have a current serious or unstable illness that could interfere with completion of the study
  • Subject has a known brain lesion, pathology or traumatic brain injury
  • Have received or participated in a trial with investigational medications in the past 30 days
  • Have had a radiopharmaceutical imaging or treatment procedure within 7 days of study imaging session
  • Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Amyloid Negative Subjects
Approximately 10 cognitively normal young subjects will receive a single i.v. bolus injection of approximately 370 megabecquerel (MBq) (10 millicurie [mCi]) florbetapir (18F) and a single i.v. bolus injection of approximately 555 MBq (15 mCi) 11C-PiB.
Other Names:
  • Amyvid
  • 18F-AV-45
  • Florbetapir F 18
Other Names:
  • Pittsburgh Compound B
Experimental: Amyloid Positive Subjects
Approximately 25 subjects with a range of amyloid density comprised of subjects clinically diagnosed with Alzheimer's Disease (AD) and subjects at risk for elevated amyloid density will receive a single i.v. bolus injection of approximately 370 MBq (10 mCi) florbetapir (18F) and a single i.v. bolus injection of approximately 555 MBq (15 mCi) 11C-PiB.
Other Names:
  • Amyvid
  • 18F-AV-45
  • Florbetapir F 18
Other Names:
  • Pittsburgh Compound B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Florbetapir SUVr Conversion to Centiloid Units
Time Frame: up to 70 minutes post injection
Conversion of florbetapir (18F) positron emission tomography (PET) standard uptake value ratio (SUVr) to Centiloid units. The Centiloid is anchored at values of 0 and 100 corresponding to the median Pittsburgh Compound B (11C-PiB) SUVr value for a representative group of young (<45) cognitively and medically healthy control subjects (YHC) and the median SUVr value for a representative group of 11C-PiB positive patients diagnosed with Alzheimer's disease, respectively. A cortical average to cerebellum SUVr was used for this outcome measure.
up to 70 minutes post injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of Florbetapir (18F) Centiloid and 11C-PiB Centiloid
Time Frame: up to 70 minutes post injection
Correlation coefficient between 11C-PiB and florbetapir (18F) SUVr as converted to centiloid units. The Centiloid is anchored at values of 0 and 100 corresponding to the median Pittsburgh Compound B (11C-PiB) SUVr value for a representative group of young (<45) cognitively and medically healthy control subjects (YHC) and the median SUVr value for a representative group of 11C-PiB positive patients diagnosed with Alzheimer's disease, respectively. A cortical average to cerebellum SUVr was used for this outcome measure.
up to 70 minutes post injection
Variability of PET Images in Young Healthy Control Subjects.
Time Frame: up to 70 minutes post injection
Coefficient of variation for 11C-PiB and florbetapir (18F) SUVr. A cortical average to cerebellum SUVr was used for this outcome measure.
up to 70 minutes post injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

April 17, 2014

First Submitted That Met QC Criteria

April 21, 2014

First Posted (Estimate)

April 23, 2014

Study Record Updates

Last Update Posted (Actual)

March 9, 2017

Last Update Submitted That Met QC Criteria

January 20, 2017

Last Verified

January 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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