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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 90
View:

• Male or Female

• Age ≥ 40 years

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

Locations
Other Locations
China
Department of Nuclear Medicine, Peking Union Medical College Hopital
RECRUITING
Beijing
Contact Information
Primary
Li Huo
huoli@pumch.cn
+861069155513
Time Frame
Start Date: 2023-01-30
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 150
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Peking Union Medical College Hospital

This content was sourced from clinicaltrials.gov