PET imaging with [18F]Flortaucipir to visualize tau in Alzheimer's and MCI

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Chinese PLA General Hospital
  Beijing, Beijing Municipality, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.