[18F]NIDF PET Imaging in Tau-related Diseases

In the field of diagnosing brain neurodegenerative diseases, it is now a well-established practice to inject positron-emitting tracers into the human body. These tracers bind to specific target proteins, allowing their distribution to be visualized via PET imaging. Currently, several research groups worldwide are engaged in developing and clinically validating their own tau imaging agents.

This clinical research project aims to visualize abnormal tau pathology in the living human brain using [18F]NIDF PET imaging. [18F]NIDF is a 2-arene-azaindole-based tracer that offers stronger binding affinity to tau neurofibrillary tangles and reduced non-specific/off-target binding compared to existing tau-PET imaging agents. The study primarily focuses on evaluating the safety and diagnostic efficacy of [18F]NIDF PET imaging in human subjects.

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Key information

Conditions

Neurodegenerative Disease Alzheimer Disease Alzheimer s Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of University of Science and Technology of China, Hefei, Anhui, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Between 18 and 90 years old;
No gender limitation;
Clinical diagnositic rerults supported the diagnosis of neurodegeneration, and there was no evidence of other neurological diseases;
Healthy participants or patients with probable Alzheimer's disease or with dementia due to other causes;
Informed consent signed in person by the subject or his legal guardian or caregiver.

Exclusion criteria

Has allergy to [18F]NIDF or any of its excipients;
Incapable of providing written informed consent or lacking a legally authorized representative (LAR) to provide informed consent ;
Unwilling or unable to undergo PET scans tracer injections;
Any condition that, in the Investigator's opinion, could increase the risk to the participant, limit the participant's ability to tolerate the research procedures, or interfere with the collection/analysis of the data (e.g., renal or liver failure, advanced cancer);
Received an experimental drug or device within 1 month (whose efficacy or safety is unclear);
Have other serious neurological disorders, or gastrointestinal, cardiovascular, liver, kidney, blood system, tumor, endocrine, respiratory, immune deficiency, and other serious diseases;
Women who are currently pregnant or breastfeeding.

Treatment and study plan

Primary outcomes

Safety Assessment

Time frame: From time of injection up to 7 days post-injection

The incidence of adverse events assessed by the investigator as related to the [18F]NIDF injection. Systematically collect and assess all adverse events within 7 days post-injection through physical examinations, vital signs monitoring, clinical laboratory tests (complete blood count, hepatic and renal function). All events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
The Biodistribution of [18F]NIDF in subjects

Time frame: At the time of the single [18F]FT8 PET/CT scan (Day 1)

Semi-quantitatively evaluate the tracer's uptake in the interest brain regions, like cortical cortex, hippocampus and cerebellum, by measuring the Standard Uptake Value (SUV) or % inject dose per volum (%ID/cc).

Secondary outcomes

Diagnostic Performance

Time frame: From enrollment to the end of PET/CT sacns at 2 weeks

Diagnostic performance including sensitivity, specificity, accuracy. Quantification of [18F]NIDF uptake in different brain regions (e.g., amygdala, temporal lobe, hippcampus) using the Standardized Uptake Value (SUV). This measurement will be performed on the PET/CT scans acquired at a specified time. The outcome will be reported as the SUV in both two groups.

Study contacts

Contact information is provided by the study sponsor or research team.

Ying Wang, MD

CONTACT

[email protected]

+8618702292537

Sponsors and collaborators

Lead sponsor

Tianjin Medical University

Other

Collaborators

Tianjin Medical University General Hospital

Registry information

Important dates

Study start: 2025
Primary completion: 2030
Study completion: 2030
First posted: Dec 29, 2025
Registry last updated: Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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