[18F]NIDF PET Imaging in Tau-related Diseases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Neurodegenerative Disease, Alzheimer s Disease, Tauopathies. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Safety Assessment [Time frame: From time of injection up to 7 days post-injection]
- The Biodistribution of [18F]NIDF in subjects [Time frame: At the time of the single [18F]FT8 PET/CT scan (Day 1)]
Secondary outcome measures (1)
- Diagnostic Performance [Time frame: From enrollment to the end of PET/CT sacns at 2 weeks]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 2 centers
- The First Affiliated Hospital of University of Science and Technology of China — Hefei
- Tianjin Medical University General Hospital — Tianjin
Identifiers
NCT: NCT07306598 · TJMUGH-13