[18F]Florbetazine ([18F]92) for Beta Amyloid PET Imaging in Alzheimer's Disease

[18F]Florbetazine ([18F]92) is a molecularly targeted imaging agent for Aβ protein with a novel diaryl-azine scaffold. It has shown specific binding affinity to Aβ aggregates in postmortem human AD brains and excellent brain pharmacokinetic properties with little non-specific retention in white matter in animal studies and a limited number of patients with Alzheimer's Disease (AD).

The purpose of the current study is to examine the binding properties of [18F]Florbetazine in human subjects and to compare the cortical and white matter binding with [11C]PiB or [18F]Florbetapir in the same subjects.

Imaging of the brain will be completed in healthy adult normal control participants and participants with cognitive impairment (including probable AD and dementia due to other conditions) to characterize [18F]Florbetazine uptake in the brain and its binding properties. [11C]PIB or [18F]Florbetapir PET imaging along with MRI will be completed in the same participants and the data will be compared with 18F-[18F]Florbetazine.

Study Overview

• Status: Recruiting
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Drug: [18F]Florbetazine ([18F]92); Drug: [11C]PIB

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Li Huo; Phone Number: +861069155513; Email: huoli@pumch.cn

Study Locations

• China
  • Beijing, China, 100730
    • Recruiting
    • Department of Nuclear Medicine, Peking Union Medical College Hopital
    • Contact: Li Huo; Phone Number: 86-10-13910801986; Email: huoli@pumch.cn
    • Contact: Meiqi Wu; Phone Number: +8618810309905; Email: wumqpumch@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Healthy participants of patients with probable Alzheimer's disease or with dementia due to other causes

Description

Inclusion Criteria:

• Male or Female
• Age ≥ 40 years
• Healthy participants or patients with probable Alzheimer's disease or with dementia due to other causes

Exclusion Criteria:

• Has allergy to [18F]Florbetazine or any of its excipients ;
• Has hypersensitivity to [11C]PIB or any of its excipients ;
• Incapable of providing written informed consent or lacking a legally authorized representative (LAR) to provide informed consent ;
• Unwilling or unable to undergo PET scans tracer injections ;
• Unwilling or unable to undergo MRI;
• Any condition that, in the Investigator's opinion, could increase the risk to the participant, limit the participant's ability to tolerate the research procedures, or interfere with the collection/analysis of the data (e.g., renal or liver failure, advanced cancer);
• Women who are currently pregnant or breastfeeding;

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy participants; Drug: [18F]Florbetazine ([18F]92). A dosage of 10 mCi +/- 20% of Florbetazine will be injected by a PET-certified medical professional followed by 5ml 0.9% sodium chloride (normal saline) flush. Drug: [11C]PIB. A dosage range between 6.0-20.0 mCi of PIB will be injected by a PET-certified medical professional followed by 5ml 0.9% sodium chloride (normal saline) flush.	Drug: [18F]Florbetazine ([18F]92); Participants will receive a single intravenous bolus injection of 10 mCi ± 20% of the investigational radiotracer [18F]Florbetazine and will undergo a PET/CT scan.; Drug: [11C]PIB; Participants will receive a single intravenous bolus injection of 6.0-20.0mCi of the investigational radiotracer [11C]PIB and will undergo a PET/CT scan.
Patients with cognitive impairment; Drug: [18F]Florbetazine ([18F]92). A dosage of 10 mCi +/- 20% of Florbetazine will be injected by a PET-certified medical professional followed by 5ml 0.9% sodium chloride (normal saline) flush. Drug: [11C]PIB. A dosage range between 6.0-20.0 mCi of PIB will be injected by a PET-certified medical professional followed by 5ml 0.9% sodium chloride (normal saline) flush.	Drug: [18F]Florbetazine ([18F]92); Participants will receive a single intravenous bolus injection of 10 mCi ± 20% of the investigational radiotracer [18F]Florbetazine and will undergo a PET/CT scan.; Drug: [11C]PIB; Participants will receive a single intravenous bolus injection of 6.0-20.0mCi of the investigational radiotracer [11C]PIB and will undergo a PET/CT scan.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The non-displacable binding potential (BPND) of [18F]Florbetazine in healthy participants and patients with probable AD	Dynamic PET data in list-mode is required over 90 minutes in participants. The PET data will be reconstructed into specific dynamic series for kinetic modeling. The non-displacable binding potential (BPND) will be determined in target and reference tissues and compared between healthy participants and patients with probable AD.	1 year
The distribution volume ratio (DVR) of [18F]Florbetazine in healthy participants and patients with probable AD	Dynamic PET data in list-mode is required over 90 minutes in participants. The PET data will be reconstructed into specific dynamic series for kinetic modeling. The distribution volume ratio (DVR) will be determined in target and reference tissues and compared between healthy participants and patients with probable AD.	1 year
Comparison of the cortical and white matter binding of [18F]Florbetazine ([18F]92) with [11C]PIB in healthy participants and patients with cognitive decline	[18F]Florbetazine ([18F]92) PET and [11C]PIB PET will be conducted in the same subjects. standardized uptake value ratios of determined cortical and white matter regions will be calculated for both tracers and then compared.	2 years

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 11, 2023
• First Submitted That Met QC Criteria: November 19, 2023
• First Posted (Estimated): November 21, 2023

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 19, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: ZineAD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No