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Florbetapir Calibration to the Centiloid Scale

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Florbetapir (18F)
11C-PiB
Sponsored by
Avid Radiopharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Alzheimer's Disease

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Amyloid Negative Subjects

Amyloid Positive Subjects

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Florbetapir SUVr Conversion to Centiloid Units
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.

Secondary Outcome Measures

Correlation of Florbetapir (18F) Centiloid and 11C-PiB Centiloid
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.
Variability of PET Images in Young Healthy Control Subjects.
Coefficient of variation for 11C-PiB and florbetapir (18F) SUVr. A cortical average to cerebellum SUVr was used for this outcome measure.

Full Information

First Posted
April 17, 2014
Last Updated
January 20, 2017
Sponsor
Avid Radiopharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02120664
Brief Title
Florbetapir Calibration to the Centiloid Scale
Official Title
A Multicenter, Multicountry Study to Calibrate Florbetapir (18F) PET Imaging Data to the Centiloid Scale Based on 11C-PiB
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Avid Radiopharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Amyloid Negative Subjects
Arm Type
Experimental
Arm Description
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.
Arm Title
Amyloid Positive Subjects
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Florbetapir (18F)
Other Intervention Name(s)
Florbetapir F 18, Amyvid, 18F-AV-45
Intervention Type
Drug
Intervention Name(s)
11C-PiB
Other Intervention Name(s)
Pittsburgh Compound B
Primary Outcome Measure Information:
Title
Florbetapir SUVr Conversion to Centiloid Units
Description
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.
Time Frame
up to 70 minutes post injection
Secondary Outcome Measure Information:
Title
Correlation of Florbetapir (18F) Centiloid and 11C-PiB Centiloid
Description
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.
Time Frame
up to 70 minutes post injection
Title
Variability of PET Images in Young Healthy Control Subjects.
Description
Coefficient of variation for 11C-PiB and florbetapir (18F) SUVr. A cortical average to cerebellum SUVr was used for this outcome measure.
Time Frame
up to 70 minutes post injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chief Medical Officer
Organizational Affiliation
Avid Radiopharmaceuticals, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Research Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Research Site
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
25443857
Citation
Klunk WE, Koeppe RA, Price JC, Benzinger TL, Devous MD Sr, Jagust WJ, Johnson KA, Mathis CA, Minhas D, Pontecorvo MJ, Rowe CC, Skovronsky DM, Mintun MA. The Centiloid Project: standardizing quantitative amyloid plaque estimation by PET. Alzheimers Dement. 2015 Jan;11(1):1-15.e1-4. doi: 10.1016/j.jalz.2014.07.003. Epub 2014 Oct 28.
Results Reference
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Florbetapir Calibration to the Centiloid Scale

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