Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CN (cognitively normal) | Experimental |
| |
| MCI (mild cognitive impairment) | Experimental |
| |
| AD (Alzheimer's disease) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F]Flortaucipir Injection | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) | 6 days post-injection |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 360 mins |
| Time to Reach Cmax (Tmax) - Total Radioactivity and Parent Compound |
Not provided
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:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100853 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
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. |
| Up to 360 mins |
| Terminal Half-Life (t½) of Unmetabolized Parent Compound | 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. | Up to 360 mins |
| Percentage of Unmetabolized Parent Compound in Plasma | 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. | 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. | 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. | 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. | 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. | 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). | 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). | Up to 240 mins post-injection |
| Effective Dose (Whole-Body) | 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 | 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 | At 80 mins post-injection |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C000591008 | 7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole |
Not provided
Not provided
Not provided