Clinical trial NCT06141356: [18F]Florbetazine ([18F]92) for Beta Amyloid PET Imaging in Alzheimer's Disease
Official title: [18F]Florbetazine ([18F]92) for Beta Amyloid PET Imaging in Alzheimer's Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alzheimer's Disease
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-11-21
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy participants of patients with probable Alzheimer's disease or with dementia due to other causes

Brief 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 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;

Primary outcomes:
measure: The non-displacable binding potential (BPND) of [18F]Florbetazine in healthy participants and patients with probable AD
timeFrame: 1 year
measure: The distribution volume ratio (DVR) of [18F]Florbetazine in healthy participants and patients with probable AD
timeFrame: 1 year
measure: Comparison of the cortical and white matter binding of [18F]Florbetazine ([18F]92) with [11C]PIB in healthy participants and patients with cognitive decline
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Nuclear Medicine, Peking Union Medical College Hopital
Study officials:
References: