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A Non Randomized, Open-Label Phase I Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Biodistribution, Radiation Dosimetry, and Preliminary Diagnostic Efficacy of [18F]Flortaucipir Injection PET Imaging in Chinese Subjects
Led by Eli Radiopharma · Updated on 2026-05-14
18
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a non-randomized, open-label Phase I study in Chinese adults aged 50 to 85 years to evaluate the safety and tolerability of [18F]Flortaucipir Injection used during PET scans. This radioactive imaging agent is being studied to understand how it moves through the body, where it accumulates, the amount of radiation exposure it causes, and its preliminary ability to detect signs of Alzheimer's disease and mild cognitive impairment. Participants will receive a single injection of [18F]Flortaucipir, a radioactive diagnostic agent intended for brain PET imaging to estimate tau protein deposits related to Alzheimer's disease. The study includes three groups: cognitively normal individuals, those with mild cognitive impairment, and those diagnosed with probable Alzheimer's disease, each confirmed by PET and MRI criteria. The study will carefully monitor participants following the injection. During the study, participants will undergo various assessments including PET scans, MRI imaging, blood and urine tests to measure the agent’s presence and breakdown over time, and safety monitoring for adverse events up to 6 days after injection. Researchers will analyze pharmacokinetics, radiation dosimetry, and diagnostic imaging results to understand the agent’s behavior and potential diagnostic value. The total duration of participant involvement is relatively short, with close observation immediately following the PET scan.
CONDITIONS
Brief 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.
- Cognitively normal with no history of impairment, Aβ-PET negative, and MRI without significant neurodegenerative changes.
- Mild cognitive impairment meeting core criteria for AD-related MCI, Aβ-PET positive, and MRI showing neurodegenerative changes.
- Probable Alzheimer's disease dementia meeting core criteria, Aβ-PET positive, and MRI showing neurodegenerative changes.
- Fertile individuals must agree to use highly effective contraception and avoid reproduction or sperm/egg donation during the study period and for 6 months after.
You will not qualify if you...
- Pregnant or breastfeeding women.
- Major surgery within 1 month before screening or planned during the study.
- Known allergy to radioactive radiation, alcohol, [18F]Flortaucipir injection, its components, or severe allergic reactions.
- Cognitive impairment caused by conditions other than Alzheimer's disease.
- Clinically significant infarction or probable multi-infarct dementia.
- Current significant psychiatric illness such as major depression or schizophrenia.
- History of epilepsy or seizures, except childhood febrile seizures.
- Inability to tolerate PET/MRI or contraindications to these imaging methods.
- Other neurodegenerative diseases or dementias besides Alzheimer's disease.
- Any other condition making the participant unsuitable for the study according to the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 hours on the imaging day
Participants receive an injection of [18F]Flortaucipir and undergo PET imaging to assess brain tau pathology related to Alzheimer's disease.
1 imaging visit (in-person)
Duration - 6 days post-injection
Participants are monitored for safety and any adverse events following the PET imaging procedure.
Follow-up visits or contacts up to 6 days
Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853
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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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