Actively Recruiting
[18F]NIDF PET Imaging in Tau-related Diseases
Led by Tianjin Medical University · Updated on 2025-12-29
20
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
T
Tianjin Medical University
Lead Sponsor
T
Tianjin Medical University General Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of [18F]NIDF PET imaging to visualize abnormal tau protein pathology in the brains of living humans. This technique targets tau neurofibrillary tangles, which are linked to neurodegenerative diseases such as Alzheimer's and other tauopathies. The study focuses on assessing the safety and diagnostic effectiveness of this imaging agent, which may offer advantages over existing tau PET tracers due to its stronger binding and lower off-target effects. Participants will receive a single intravenous injection of approximately 10 b1 3 mCi of [18F]NIDF. Following the injection, a PET/CT scan will be performed to capture images showing the distribution of the tracer in the brain. The study includes both healthy volunteers and patients with cognitive impairment or probable Alzheimer's disease. There is only one main study period involving this single injection and imaging session. During the study, participants will be monitored for safety from the time of injection up to seven days afterward. The primary assessments include safety evaluation and measuring how the tracer spreads in the body during the PET/CT scan on the injection day. Researchers will also evaluate the diagnostic performance of the imaging over a two-week period from enrollment to the end of imaging. Participants' involvement is limited to the injection, scanning, and follow-up safety checks.
CONDITIONS
Brief Title
[18F]NIDF PET Imaging in Tau-related Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 18 and 90 years old
- No gender limitation
- Clinical diagnosis supporting neurodegeneration without other neurological diseases
- Healthy participants or patients with probable Alzheimer's disease or dementia from other causes
- Signed informed consent by the participant or their legal guardian/caregiver
You will not qualify if you...
- Allergy to [18F]NIDF or any component of the tracer
- Unable to provide written informed consent or lacking a legal representative
- Unwilling or unable to undergo PET scan injections
- Conditions increasing risk or interfering with study (e.g., renal/liver failure, advanced cancer)
- Received experimental drug or device within 1 month
- Other serious neurological or systemic diseases including gastrointestinal, cardiovascular, liver, kidney, blood, tumor, endocrine, respiratory, or immune disorders
- Women who are pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive a single intravenous injection of the imaging tracer followed by a PET/CT scan to assess brain tau pathology.
1 visit (in-person)
Duration - Up to 7 days post-injection
Participants are monitored for safety and diagnostic outcomes following the PET/CT scan.
Follow-up contacts as needed up to 7 days
Trial Site Locations
Total: 2 locations
1
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China, 230000
Actively Recruiting
2
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China, 350005
Actively Recruiting
Research Team
Y
Ying Wang, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here