PET imaging with [18F]Flortaucipir to visualize tau in Alzheimer's and MCI
A Single-Arm, Non-Randomized, Open-Label Phase I Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Biodistribution and Radiation Dosimetry, and Preliminary Diagnostic Efficacy of [18F]Flortaucipir Injection PET Imaging in Chinese Subjects
We will test whether a PET imaging agent called [18F]Flortaucipir is safe and helps show tau in the brains of Chinese adults with Alzheimer's disease or mild cognitive impairment.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 50 Years to 85 Years |
| Sex | All |
| Sponsor | Eli Radiopharma Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07580703 on ClinicalTrials.gov |
What this trial studies
This open-label, single-arm Phase I study will give a single injection of [18F]Flortaucipir to Chinese adults aged 50–85 and perform PET imaging to characterize safety, pharmacokinetics, biodistribution, and radiation dosimetry. Participants include cognitively normal controls, people with MCI related to AD, and those with probable AD dementia, classified using Aβ-PET and MRI findings. The study will collect blood samples and perform serial imaging and safety monitoring to measure how the tracer moves through the body and the radiation dose to organs. Investigators will also compare imaging patterns to clinical diagnosis to provide preliminary data on the tracer's ability to detect tau pathology.
Who should consider this trial
Good fit: Ideal candidates are adults 50–85 who can consent, including cognitively normal controls, people with MCI or probable AD with positive Aβ-PET and MRI evidence of neurodegeneration, and who agree to contraception and study procedures.
Not a fit: Pregnant or breastfeeding people, those who had major surgery within the prior month, individuals outside the age range, or those without the required Aβ-PET/MRI findings are unlikely to receive benefit from participation.
Why it matters
Potential benefit: If successful, the tracer could offer a safe, validated tau-PET imaging option to help diagnose and track Alzheimer's disease in Chinese patients.
How similar studies have performed: Other studies using [18F]Flortaucipir (AV-1451) and similar tau PET tracers have been widely used and shown they can detect tau pathology and correlate with clinical measures in AD populations.
Eligibility criteria
Show full inclusion / exclusion 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 impairment, Aβ-PET negative, MRI without clinically significant neurodegenerative changes. 2. MCI: Meet core criteria for AD-related MCI, Aβ-PET positive, MRI showing neurodegenerative changes. 3. 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). Exclusion Criteria: * 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 this trial is running
Beijing, Beijing Municipality
- Chinese PLA General Hospital — Beijing, Beijing Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.