[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.

Study Overview

• Status: Recruiting
• Conditions: Tauopathies; Neurodegenerative Disease; Alzheimer s Disease

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Ying Wang, MD; Phone Number: +8618702292537; Email: macrossplusvoices@163.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230000
      • Recruiting
      • The First Affiliated Hospital of University of Science and Technology of China
      • Contact: Qiang Xie, PhD; Phone Number: +8613721108043; Email: ahxq1980@163.com
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 350005
      • Recruiting
      • Tianjin Medical University General Hospital
      • Contact: Ying Wang, MD; Phone Number: +8618702292537; Email: macrossplusvoices@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic Performance	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.	From enrollment to the end of PET/CT sacns at 2 weeks

Collaborators and Investigators

• Sponsor: Tianjin Medical University
• Collaborators: Tianjin Medical University General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: December 14, 2025
• First Submitted That Met QC Criteria: December 14, 2025
• First Posted (Actual): December 29, 2025

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 14, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: PET/CT; Alzheimer's disease; Tauopathies; Tau pathologies
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Alzheimer Disease; Neurodegenerative Diseases; Tauopathies
• Other Study ID Numbers: TJMUGH-13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No