Florbetapir Calibration to the Centiloid Scale

NCT02120664 | Completed Phase 1 Results

• 1 other identifier: 18F-AV-45-A22
• Study Type: interventional
• Target: 35
• Locations: 2 countries
• Sites: 2

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.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 70 minutes post injection

Secondary Outcomes (2)

• Correlation of Florbetapir (18F) Centiloid and 11C-PiB Centiloid

  up to 70 minutes post injection

• Variability of PET Images in Young Healthy Control Subjects.

  up to 70 minutes post injection

Study Arms (2)

Amyloid Negative Subjects

EXPERIMENTAL

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.

Drug: Florbetapir (18F); Drug: 11C-PiB

Amyloid Positive Subjects

EXPERIMENTAL

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.

Drug: Florbetapir (18F); Drug: 11C-PiB

Interventions

Florbetapir (18F) DRUG

Also known as: Florbetapir F 18, Amyvid, 18F-AV-45

Amyloid Negative Subjects; Amyloid Positive Subjects

11C-PiB DRUG

Also known as: Pittsburgh Compound B

Amyloid Negative Subjects; Amyloid Positive Subjects

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Avid Radiopharmaceuticals: lead

Study Sites (2)

Research Site

Pittsburgh, Pennsylvania, 15213, United States

Location

Research Site

Heidelberg, Victoria, 3084, Australia

Location

Related Publications (1)

• 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.

  PMID: 25443857 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease

Interventions

florbetapir; 2-(4'-(methylamino)phenyl)-6-hydroxybenzothiazole

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Avid Radiopharmaceuticals, Inc.

clinicaloperations@avidrp.com

215-298-0700

Study Officials

• Chief Medical Officer

  Avid Radiopharmaceuticals, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2014
• First Posted: April 23, 2014
• Study Start: April 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: March 9, 2017
• Results First Posted: March 9, 2017

Record last verified: 2017-01

Locations

US (1); AU (1)