A Phase 1 interventional study of [18F]Flortaucipir Injection in AD - Alzheimer's Disease and MCI, sponsored by Eli Radiopharma. Recruiting at 1 site in China. Open to participants aged 50 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by Eli Radiopharma · Phase 1, Interventional, and Diagnostic
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).
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's planned enrollment of 18 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →This is the only study on the registry with Eli Radiopharma as lead sponsor.
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Meet the following criteria related to cognitive impairment:
Exclusion Criteria:
Drug: [18F]Flortaucipir Injection
Drug: [18F]Flortaucipir Injection
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).
Also known as: ELI-101
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)
Time frame: 6 days post-injection
Maximum Observed Plasma Concentration (Cmax) - Total Radioactivity and Parent Compound
Cmax is defined as the highest observed plasma concentration of total radioactivity (measured by gamma counting) and of the unmetabolized parent \[18F\]Flortaucipir
Time frame: Up to 360 mins
Time to Reach Cmax (Tmax) - Total Radioactivity and Parent Compound
Tmax is the time (in minutes) at which the maximum plasma concentration (Cmax) occurs, recorded as the midpoint of the sampling interval during which the maximum is observed.
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
AUC0-t is calculated using the linear trapezoidal rule from time 0 to the last measurable concentration. AUC0-∞ is extrapolated as AUC0-t + Ct/λz, where Ct is the last quantifiable concentration and λz is the terminal elimination rate constant.
Time frame: Up to 360 mins
Percentage of Unmetabolized Parent Compound in Plasma
Time frame: Up to 360 mins
Urinary Radioactive Excretion Rate
Rate of radioactivity excreted in urine, expressed as percentage of injected dose per hour (%ID/h). Measured by gamma counting of collected urine aliquots over specified intervals.
Time frame: 0-60, 60-120, 120-240, 240-360 mins post-injection
Cumulative Urinary Excretion of Radioactivity
Total cumulative percentage of the injected radioactive dose recovered in urine over time. Calculated as the sum of radioactivity excreted at each collection interval.
Time frame: Up to 360 mins post-injection
Percentage of Unmetabolized Parent Compound and Metabolites in Urine
Relative proportion of total urinary radioactivity that corresponds to the intact \[18F\]Flortaucipir and its known radioactive metabolites.
Time frame: Up to 360 mins post-injection
Organ/Tissue Radioactivity Uptake - Percent Injected Dose (%ID)
Percentage of the injected radioactive dose (%ID) present in each target organ or tissue (e.g., brain, liver, kidneys, lungs, bone marrow, etc.) at specified imaging time points.
Time frame: Up to 240 mins post-injection
Mean Standardized Uptake Value (SUVmean) in Target Organs/Tissues
SUVmean is defined as the mean tissue radioactivity concentration (decay-corrected) normalized by injected dose per body weight.
Time frame: Up to 240 mins post-injection
Residence Time (Source Organ Time-Integrated Activity)
Residence time (also known as time-integrated activity coefficient) for each source organ, expressed as hours (or minutes).
Time frame: Up to 240 mins post-injection
Absorbed Dose to Target Organs/Tissues
Absorbed dose (mGy) to each target organ/tissue (e.g., brain, liver, kidneys, urinary bladder wall, lungs, red marrow, heart wall, spleen, thyroid, etc.) per unit administered activity (mGy/MBq).
Time frame: Up to 240 mins post-injection
Effective Dose (Whole-Body)
Time frame: Up to 240 mins post-injection
Visual Read Positivity Rate - Overall and by Subject Subgroup
Proportion of subjects with a positive PET scan based on visual assessment (blinded, independent readers) using a predefined read criterion
Time frame: At 80 mins post-injection
Standardized Uptake Value Ratio (SUVR) - Composite Region
SUVR is calculated as the mean standardized uptake value (SUV) in a composite target region of interest
Time frame: At 80 mins post-injection
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