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Recruiting NCT07580703

A Phase I Study of [18F]Flortaucipir PET Imaging in Chinese Subjects: Safety, Pharmacokinetics, Biodistribution, Radiation Dosimetry, and Preliminary Diagnostic Efficacy

Phase I Interventional AD - Alzheimer's Disease MCI

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: [18F]Flortaucipir Injection.
Who it may be relevant to
Registry conditions: AD - Alzheimer's Disease, MCI. Basic parameters: 50 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A 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

Overview

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).

Interventions

  • Drug [18F]Flortaucipir Injection
    A radioactive diagnostic agent intended for brain positron emission tomography (PET) imaging in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD), to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs).

Primary outcome measures

  • Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) [Time frame: 6 days post-injection]
Secondary outcome measures (12)
  • Maximum Observed Plasma Concentration (Cmax) - Total Radioactivity and Parent Compound [Time frame: Up to 360 mins]
  • Time to Reach Cmax (Tmax) - Total Radioactivity and Parent Compound [Time frame: Up to 360 mins]
  • Terminal Half-Life (t½) of Unmetabolized Parent Compound [Time frame: Up to 360 mins]
  • Area Under the Plasma Concentration-Time Curve (AUC0-t and AUC0-∞) of Unmetabolized Parent Compound [Time frame: Up to 360 mins]
  • Percentage of Unmetabolized Parent Compound in Plasma [Time frame: Up to 360 mins]
  • Urinary Radioactive Excretion Rate [Time frame: 0-60, 60-120, 120-240, 240-360 mins post-injection]
  • Cumulative Urinary Excretion of Radioactivity [Time frame: Up to 360 mins post-injection]
  • Percentage of Unmetabolized Parent Compound and Metabolites in Urine [Time frame: Up to 360 mins post-injection]
  • Organ/Tissue Radioactivity Uptake - Percent Injected Dose (%ID) [Time frame: Up to 240 mins post-injection]
  • Mean Standardized Uptake Value (SUVmean) in Target Organs/Tissues [Time frame: Up to 240 mins post-injection]
  • Residence Time (Source Organ Time-Integrated Activity) [Time frame: Up to 240 mins post-injection]
  • Absorbed Dose to Target Organs/Tissues [Time frame: Up to 240 mins post-injection]

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:
  • CN: No history of cognitive impairment, Aβ-PET negative, MRI without clinically significant neurodegenerative changes.
  • MCI: Meet core criteria for AD-related MCI, Aβ-PET positive, MRI showing neurodegenerative changes.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

China · 1 center
  • Chinese PLA General Hospital — Beijing

Identifiers

NCT: NCT07580703 · ELI-101-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗