18F‑XTR006 PET imaging to detect brain tau (neurofibrillary tangles) in normal, MCI, and Alzheimer’s patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, single-blind, non-randomized Phase 3 imaging study that gives participants an XTR006 injection followed by PET/CT scanning. Trained nuclear medicine physicians will perform blinded visual reads, with three expert readers selected and consensus determined by at least two agreeing. Diagnostic performance (sensitivity and specificity) will be calculated against a composite reference standard of clinical cognitive assessment plus Aβ‑PET, and the primary goal is for the lower bound of the 95% confidence interval to exceed 60%. The study will also analyze semi-quantitative SUVR uptake differences across groups and monitor safety via adverse event reporting.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Inclusion Criteria for All Subjects:

1. Male or female subjects aged ≥50 years.
2. Able to tolerate both PET and MRI examinations.
3. Must use contraceptive measures during the study period and for 6 months after study completion.
4. Written informed consent must be obtained before any assessment is performed.

Inclusion Criteria for Cognitively Normal Subjects:

1)CDR (Clinical Dementia Rating) score of 0. 2）MMSE (Mini-Mental State Examination) score ≥28. 3）Negative visual reading result on brain Aβ-PET imaging.

Inclusion Criteria for Subjects with MCI:

1. Meet the core clinical criteria for MCI due to AD according to 2011 NIA-AA (National Institute on Aging-Alzheimer's Association) standards
2. Positive visual reading result on brain Aβ-PET imaging

Inclusion Criteria for Subjects with AD:

1. Meet the specific clinical phenotype criteria for typical AD according to 2014 International Working Group (IWG)-2 standards:
2. Positive visual reading result on brain Aβ-PET imaging.

Exclusion Criteria:

1. Diagnosis of atypical AD, frontotemporal lobar degeneration (FTLD), Lewy body dementia, or other types of dementia.
2. Current significant psychiatric illness with symptoms that prevent completion of imaging procedures.
3. MRI-confirmed structural brain abnormalities, such as large stroke or intracranial mass lesions.
4. Claustrophobia.
5. History of alcohol abuse or drug abuse/dependence.
6. Allergy to the study drug or any of its components.
7. Women who are currently breastfeeding.

Where it's running

• Chinese PLA General Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Jiong Shi, Doctor — The First Affiliated Hospital of University of Science and Technology of China
• Study coordinator: Jiong Shi, Doctor
• Email: jshi2022@ystc.edu.cn
• Phone: 15512191857

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.