What is this study trying to find out about neurodegenerative diseases?

This study aims to assess the safety and ability of [18F]NIDF PET imaging to detect abnormal tau protein buildup in the brain, which is linked to neurodegenerative conditions like Alzheimer's disease. It is conducted by Tianjin Medical University to better understand diagnostic imaging options. Participants can expect to receive an injection followed by a brain scan to visualize tau pathology.

Who may be eligible for this neurodegenerative disease clinical trial?

Adults aged 18 to 90 years diagnosed with neurodegenerative disease or cognitive impairment may be eligible, including healthy volunteers. There is no gender restriction. Important factors include the ability to consent, willingness to undergo PET scans, and absence of serious other health conditions. Please review eligibility criteria for more details.

Is there any cost to participate in this neurodegenerative disease clinical trial?

Study-related care, including the imaging tracer injection and all trial visits, is provided at no cost. Personal travel and other expenses are not guaranteed to be covered and may vary. Participants should plan accordingly for any costs outside the study procedures.

Actively Recruiting

Age: 18Years - 90Years

All Genders

Healthy Volunteers

ID07306598

18FNIDF PET Imaging in Tau-related Diseases

Led by Tianjin Medical University · Updated on 2025-12-29

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the use of 18FNIDF 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 Alzheimers 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 18FNIDF. Following the injection, a PETCT 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 Alzheimers 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 PETCT 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

Age: 18Years - 90Years

All Genders

Healthy Volunteers

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

Research Team

Ying Wang, MD

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