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

NCT07306598 | Recruiting

• 1 other identifier: TJMUGH-13
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Neurodegenerative Disease; Alzheimer s Disease; Tauopathies

Keywords

PET/CT; Alzheimer's disease; Tau pathologies; Tauopathies

Outcome Measures

Primary Outcomes (2)

• Safety Assessment

  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.

  From time of injection up to 7 days post-injection

• The Biodistribution of [18F]NIDF in subjects

  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).

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

Secondary Outcomes (1)

• Diagnostic Performance

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

Study Arms (2)

Healthy participants

Participants will receive a single intravenous bolus injection of 10 ± 3 mCi of \[18F\]NIDF followed by a PET/CT scan.

Patients with cognitive impairment

Participants will receive a single intravenous bolus injection of 10 ± 3 mCi of \[18F\]NIDF followed by a PET/CT scan.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University: lead
• Tianjin Medical University General Hospital: collaborator

Study Sites (2)

The First Affiliated Hospital of University of Science and Technology of China

Hefei, Anhui, 230000, China

RECRUITING

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 350005, China

RECRUITING

MeSH Terms

Conditions

Neurodegenerative Diseases; Tauopathies; Alzheimer Disease

Condition Hierarchy (Ancestors)

Nervous System Diseases; Dementia; Brain Diseases; Central Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Ying Wang, MD

CONTACT

+8618702292537; macrossplusvoices@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: December 14, 2025
• First Posted: December 29, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)