Neurodegenerative DiseaseNCT07306598
[18F]NIDF PET Imaging in Tau-related Diseases
An observational study of Neurodegenerative Disease and Alzheimer s Disease, run by Tianjin Medical University at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurodegenerative Disease, Alzheimer s Disease, Tauopathies
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 3 sitesChina
- Study dates
- 1 Nov 2025to 1 Dec 2030
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, 230000
Qiang Xie, PhD, +8613721108043, ahxq1980@163.com
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
Guangjie Yang, MD, +8617853297979, ygj_2815@qdu.edu.cn
- Recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 350005
Ying Wang, MD, +8618702292537, macrossplusvoices@163.com
About this study
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
- Medical subject headings
- Neurodegenerative Diseases, Tauopathies, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: At the time of the single [18F]FT8 PET/CT scan (Day 1)
Secondary outcomes (1)
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.
Measured: From enrollment to the end of PET/CT sacns at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start1 Nov 2025
- Primary completion1 Dec 2030 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodegenerative DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Medical University General Hospital
- Responsible party
- Principal investigator, Shaobo Yao, PhD, Tianjin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07306598
- Sponsor's protocol ID
- TJMUGH-13
- Status last verified
- Sep 2026
- First submitted
- 14 Dec 2025
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [18F]NIDF PET Imaging in Tau-related Diseases
- ClinicalTrials.gov ID
- NCT07306598
- Acronym / sponsor ID
- TJMUGH-13
- Conditions
- Neurodegenerative Disease, Alzheimer s Disease, Tauopathies
- Keywords
- PET/CT, Alzheimer's disease, Tau pathologies, Tauopathies
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tianjin Medical UniversityUniversity, hospital or other
- Collaborators
- Tianjin Medical University General Hospital
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Dec 2030 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
1 secondary outcome
Diagnostic Performance
Time frame: From enrollment to the end of PET/CT sacns at 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurodegenerative Disease and Alzheimer s Disease, run by Tianjin Medical University at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ying Wang, MD (+8618702292537, macrossplusvoices@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Assessment (time frame: From time of injection up to 7 days post-injection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.