A Phase I Study of [18F]Flortaucipir PET Imaging in Chinese Subjects: Safety, Pharmacokinetics, Biodistribution, Radiation Dosimetry, and Preliminary Diagnostic Efficacy
Recruiting
Phase 1
Interventional Study
AD - Alzheimer's Disease
MCI
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 50 – 85
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Diagnostic
- Participants needed
- 18 (estimated)
- Sponsor
- Eli Radiopharma · Industry
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About This Trial
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 expos…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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:
1. CN: No history of cognitive impair…
Contacts
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