NCT07580703

Brief 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. 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
10mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
Apr 2026Mar 2027

Study Start

First participant enrolled

April 23, 2026

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 12, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

May 14, 2026

Status Verified

May 1, 2026

Enrollment Period

8 months

First QC Date

April 26, 2026

Last Update Submit

May 11, 2026

Conditions

AD - Alzheimer's DiseaseMCI

Keywords

tau-PET[18F]FlortaucipirPhase IELI-101ELI-101-001ADAlzheimer's diseaseMCI

Outcome Measures

Primary Outcomes (1)

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

    6 days post-injection

Secondary Outcomes (15)

  • Maximum Observed Plasma Concentration (Cmax) - Total Radioactivity and Parent Compound

    Up to 360 mins

  • Time to Reach Cmax (Tmax) - Total Radioactivity and Parent Compound

    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

    Up to 360 mins

  • Percentage of Unmetabolized Parent Compound in Plasma

    Up to 360 mins

  • +10 more secondary outcomes

Study Arms (3)

CN (cognitively normal)

EXPERIMENTAL
Drug: [18F]Flortaucipir Injection

MCI (mild cognitive impairment)

EXPERIMENTAL
Drug: [18F]Flortaucipir Injection

AD (Alzheimer's disease)

EXPERIMENTAL
Drug: [18F]Flortaucipir Injection

Interventions

[18F]Flortaucipir InjectionDRUG

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
AD (Alzheimer's disease)CN (cognitively normal)MCI (mild cognitive impairment)

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Interventions

7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2026

First Posted

May 12, 2026

Study Start

April 23, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 31, 2027

Last Updated

May 14, 2026

Record last verified: 2026-05

Locations

CN(1)