A Phase I Study of [18F]Flortaucipir PET Imaging in Chinese Subjects: Safety, Pharmacokinetics, Biodistribution, Radiation Dosimetry, and Preliminary Diagnostic Efficacy

Recruiting now · Phase 1

Conditions studied: AD - Alzheimer's Disease, MCI

In brief

This is a non randomized, open-label Phase I study in Chinese participants. The goal of this clinical trial is to evaluate the safety and tolerability of a radioactive imaging agent called \[18F\]Flortaucipir Injection, which is used during a PET scan. The study will also measure how the agent moves through the body (pharmacokinetics), where it goes (biodistribution), the amount of radiation exposure (radiation dosimetry), and how well it may help detect signs of disease (preliminary diagnostic efficacy).

Key facts

Study ID

NCT07580703

Run by

Eli Radiopharma

People needed

18

Starts

2026-04-23

Expected to finish

2027-03-31

Last updated by the study team

2026-05-14

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Signed informed consent form (ICF).
• Male or female aged 50-85 years.
• Education level sufficient to cooperate with neuropsychological testing and obtain reliable results.
• Meet the following criteria related to cognitive impairment:
• CN: No history of cognitive impairment, Aβ-PET negative, MRI without clinically significant neurodegenerative changes.
• MCI: Meet core criteria for AD-related MCI, Aβ-PET positive, MRI showing neurodegenerative changes.
• AD: Meet core criteria for probable AD dementia, Aβ-PET positive, MRI showing neurodegenerative changes.
• Fertile individuals: No plan for reproduction, sperm/egg donation within 6 months after signing ICF and until 6 months after study drug administration; and agreement to use highly effective contraception (including partner).

You may not qualify if…

• Pregnant (positive pregnancy test at screening or before administration) or breastfeeding women.
• Major surgery within 1 month prior to screening, or planned surgery during the study period.
• Known allergy to radioactive radiation, alcohol, [18F]Flortaucipir injection, or its excipients, or other severe allergic reactions.
• Cognitive impairment due to causes other than AD.
• Clinically significant infarction or probable multi-infarct dementia.
• Current clinically significant psychiatric illness (e.g., major depression, schizophrenia).
• History of epilepsy or seizures (except febrile seizures in childhood).
• Inability to tolerate PET/MRI or presence of contraindications to PET/MRI.
• Other neurodegenerative diseases or dementias other than AD dementia.
• Any other condition that, in the investigator's opinion, makes the subject unsuitable for the study.

Where it is running

• Chinese PLA General Hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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