Brain PET scan with [18F]NIDF to see tau protein in Alzheimer’s and other tau-related diseases

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

We are testing whether a new PET tracer called [18F]NIDF can safely show tau protein in the brains of healthy adults and people with Alzheimer’s disease or other tauopathies.

Quick facts

• Study type: Observational
• Enrollment: 20 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Tianjin Medical University (Academic / other)
• Locations: 2 sites (Hefei, Anhui and 1 other locations)
• Trial ID: NCT07306598 on ClinicalTrials.gov

What this trial studies

This observational imaging project uses the radioactive tracer [18F]NIDF injected before PET scanning to visualize abnormal tau neurofibrillary tangles in living human brains. The tracer is a 2-arene-azaindole-based compound designed for stronger tau binding and reduced off-target signal compared with existing tau PET agents. Adult participants (ages 18–90), including healthy volunteers and people with probable Alzheimer’s or other dementias, will be enrolled and undergo tracer injection and PET imaging at participating hospitals. The primary focus is on imaging safety and how well the tracer highlights tau pathology for diagnostic use.

Who should consider this trial

Good fit: Adults aged 18–90 who can give informed consent (or have a legal representative), including healthy controls and people with probable Alzheimer’s disease or other causes of dementia, are eligible if they have no other neurological diseases and can tolerate PET procedures.

Not a fit: People who cannot consent, are allergic to the tracer or its excipients, are unwilling or unable to undergo PET scans, or have major medical conditions that interfere with imaging or safety may not benefit from participation.

Why it matters

Potential benefit: If successful, this tracer could improve the accuracy and clarity of tau imaging, helping doctors detect and track Alzheimer’s and other tauopathies earlier and more reliably.

How similar studies have performed: Other tau PET tracers have been used successfully in research and clinical settings, but [18F]NIDF is a newer agent claiming stronger tau binding and less off-target uptake and is being tested clinically.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Has allergy to \[18F\]NIDF or any of its excipients;
2. Incapable of providing written informed consent or lacking a legally authorized representative (LAR) to provide informed consent ;
3. Unwilling or unable to undergo PET scans tracer injections;
4. 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);
5. Received an experimental drug or device within 1 month (whose efficacy or safety is unclear);
6. Have other serious neurological disorders, or gastrointestinal, cardiovascular, liver, kidney, blood system, tumor, endocrine, respiratory, immune deficiency, and other serious diseases;
7. Women who are currently pregnant or breastfeeding.

Where this trial is running

Hefei, Anhui and 1 other locations

• The First Affiliated Hospital of University of Science and Technology of China — Hefei, Anhui, China (Recruiting)
• Tianjin Medical University General Hospital — Tianjin, Tianjin Municipality, China (Recruiting)

Study contacts

• Study coordinator: Ying Wang, MD

Conditions Neurodegenerative Disease; Alzheimer s Disease; Tauopathies; PET/CT; Alzheimer's disease; Tau pathologies