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

Last updated: November 19, 2023
Sponsor: Peking Union Medical College Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Alzheimer's Disease

Memory Loss

Dementia

Treatment

[11C]PIB

[18F]Florbetazine ([18F]92)

Clinical Study ID

NCT06141356
ZineAD
  • Ages 40-90
  • All Genders

Study Summary

[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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 authorizedrepresentative (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 theparticipant, limit the participant's ability to tolerate the research procedures, orinterfere with the collection/analysis of the data (e.g., renal or liver failure,advanced cancer);
  • Women who are currently pregnant or breastfeeding;

Study Design

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: [11C]PIB
Phase:
Study Start date:
January 30, 2023
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Department of Nuclear Medicine, Peking Union Medical College Hopital

    Beijing, 100730
    China

    Active - Recruiting

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