A Clinical Study Evaluating the Diagnostic Performance and Safety of PET for the Deposition of Aβ Plaques in the Brain of Participants With Normal Cognitive Function, MCI and AD Using [18F]Fluorbetazine Injection

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age40+
SponsorHTA Co., Ltd.

About this trial

A multicenter phase III clinical study evaluating the diagnostic performance and safety of PET for the deposition of Aβ plaques in the brain of participants with normal cognitive function, MCI and AD using \[18F\]Fluorbetazine injection.

Eligibility criteria

Qualifiers

None

Disqualifiers

Known allergy to [18F]Fluorbetazine injection or its excipients.

Presence of previously implanted metal devices that are incompatible with MRI examinations, including pacemakers, defibrillators, insulin pumps, cochlear implants, intraocular metal implants, nerve stimulators, or CNS aneurysm clips; or suffering from claustrophobia or intolerance to imaging procedures for other reasons.

Cognitive impairment caused by reasons other than Alzheimer's disease (AD).

More than 2 infarctions with a diameter greater than 2 cm in any part of the brain;

Trial design

Treatments tested in this trial

  • [18F]Fluorbetazine injection

Treatment groups

400 Participants
are divided into 1 treatment group

Sponsors and collaborators