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

NCT ID: NCT07306598

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-01

Study Completion Date

2030-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Neurodegenerative Disease Alzheimer s Disease Tauopathies

Keywords

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PET/CT Alzheimer's disease Tau pathologies Tauopathies

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy participants

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

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tianjin Medical University General Hospital

OTHER

Sponsor Role collaborator

Tianjin Medical University

OTHER

Sponsor Role lead

Responsible Party

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Shaobo Yao, PhD

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Hefei, Anhui, China

Site Status RECRUITING

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ying Wang, MD

Role: CONTACT

Phone: +8618702292537

Email: [email protected]

Facility Contacts

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Qiang Xie, PhD

Role: primary

Ying Wang, MD

Role: primary

Other Identifiers

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TJMUGH-13

Identifier Type: -

Identifier Source: org_study_id