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AD - Alzheimer's DiseasePhase 1NCT07580703

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

A Phase 1 study testing [18F]Flortaucipir Injection in people with AD - Alzheimer's Disease and MCI, run by Eli Radiopharma at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 50 to 85 yearsHealthy volunteers can take part
Conditions the study is for
AD - Alzheimer's Disease, MCI
What is being tested?
[18F]Flortaucipir Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteChina
Study dates
23 Apr 2026to 31 Mar 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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).
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100853

    Dr. Wang Ruimin, Doctor, 86-13501151740, wrm@yeah.net

    Recruiting

Other trials in China

About this study

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

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).

Being tested
[18F]Flortaucipir Injection
Keywords
tau-PET, [18F]Flortaucipir, Phase I, ELI-101, ELI-101-001, AD, Alzheimer's disease, MCI
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [18F]Flortaucipir InjectionDrug

    Also called ELI-101

    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).

Study groups in NCT07580703
Study groupRoleWhat they receive
CN (cognitively normal)ExperimentalNot described
Receives: Drug: [18F]Flortaucipir Injection
MCI (mild cognitive impairment)ExperimentalNot described
Receives: Drug: [18F]Flortaucipir Injection
AD (Alzheimer's disease)ExperimentalNot described
Receives: Drug: [18F]Flortaucipir Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)

    Measured: 6 days post-injection

Secondary outcomes (15)

  1. 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

    Measured: Up to 360 mins

  2. 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.

    Measured: Up to 360 mins

  3. Terminal Half-Life (t½) of Unmetabolized Parent Compound

    Measured: Up to 360 mins

  4. 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.

    Measured: Up to 360 mins

  5. Percentage of Unmetabolized Parent Compound in Plasma

    Measured: Up to 360 mins

  6. 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.

    Measured: 0-60, 60-120, 120-240, 240-360 mins post-injection

  7. 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.

    Measured: Up to 360 mins post-injection

  8. 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.

    Measured: Up to 360 mins post-injection

  9. 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.

    Measured: Up to 240 mins post-injection

  10. 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.

    Measured: Up to 240 mins post-injection

  11. 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).

    Measured: Up to 240 mins post-injection

  12. 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).

    Measured: Up to 240 mins post-injection

  13. Effective Dose (Whole-Body)

    Measured: Up to 240 mins post-injection

  14. 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

    Measured: At 80 mins post-injection

  15. Standardized Uptake Value Ratio (SUVR) - Composite Region

    SUVR is calculated as the mean standardized uptake value (SUV) in a composite target region of interest

    Measured: At 80 mins post-injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2026
  2. Study start23 Apr 2026
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07580703
Sponsor's protocol ID
ELI-101-001
Status last verified
May 2026
First submitted
26 Apr 2026
Last updated
14 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [18F]Flortaucipir Injection in people with AD - Alzheimer's Disease and MCI, run by Eli Radiopharma at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) (time frame: 6 days post-injection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07580703.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.

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