Actively Recruiting
A Phase I Study of [18F]Flortaucipir PET Imaging in Chinese Subjects: Safety, Pharmacokinetics, Biodistribution, Radiation Dosimetry, and Preliminary Diagnostic Efficacy
Led by Eli Radiopharma · Updated on 2026-05-14
18
Participants Needed
1
Research Sites
48 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Phase I Study of [18F]Flortaucipir PET Imaging in Chinese Subjects: Safety, Pharmacokinetics, Biodistribution, Radiation Dosimetry, and Preliminary Diagnostic Efficacy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form (ICF).
- Male or female aged 50-85 years.
- Education level sufficient to cooperate with neuropsychological testing and obtain reliable results.
- No history of cognitive impairment with negative Ab2-PET and MRI without significant neurodegenerative changes (CN).
- Meet core criteria for AD-related mild cognitive impairment with positive Ab2-PET and MRI showing neurodegenerative changes (MCI).
- Meet core criteria for probable Alzheimer's disease dementia with positive Ab2-PET and MRI showing neurodegenerative changes (AD).
- Fertile individuals must agree to use highly effective contraception and have no plans for reproduction or sperm/egg donation during and 6 months after study drug administration.
You will not qualify if you...
- Pregnant or breastfeeding women.
- Major surgery within 1 month prior to screening or planned surgery during the study.
- Known allergy to radioactive radiation, alcohol, [18F]Flortaucipir injection, or its excipients, or other severe allergic reactions.
- Cognitive impairment due to causes other than Alzheimer's disease.
- Clinically significant infarction or probable multi-infarct dementia.
- Current clinically significant psychiatric illness such as major depression or schizophrenia.
- History of epilepsy or seizures (except febrile seizures in childhood).
- Inability to tolerate PET/MRI or contraindications to PET/MRI.
- Other neurodegenerative diseases or dementias other than Alzheimer's dementia.
- Any other condition making the participant unsuitable for the study as judged by the investigator.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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