Florbetapir Calibration to the Centiloid Scale

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02120664
• Other study ID #: 18F-AV-45-A22
• Status: Completed
• Phase: Phase 1
• First received: April 17, 2014
• Last updated: November 25, 2015
• Start date: April 2014
• Est. completion date: September 2015

Study information

• Verified date: November 2015
• Source: Avid Radiopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Florbetapir (18F)

• 11C-PiB

Locations

Country	Name	City	State
Australia	Research Site	Heidelberg	Victoria
United States	Research Site	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Avid Radiopharmaceuticals

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Florbetapir SUVr Conversion to Centiloid Units	Conversion of florbetapir (18F) PET SUVr to Centiloid units	up to 70 minutes post injection	No
Secondary	Correlation of florbetapir (18F) centiloid and 11C-PiB centiloid	Spearman rank correlation analysis between 11C-PiB and florbetapir (18F) SUVr as converted to centiloid units.	up to 70 minutes post injection	No
Secondary	Variability of PET Images in Control Subjects.	Variance and coefficient of variation for 11C-PiB and florbetapir (18F) SUVr.	up to 70 minutes post injection	No