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

A Phase 3, Multicenter Study to Evaluate the Efficacy and Safety of PET Visual Assessment Using XTR006 Injection for Detection of Brain Neurofibrillary Tangles (NFTs) in Elderly Subjects

We will test whether an injected PET tracer called XTR006 can detect neurofibrillary tangles in people aged 50 and older who are cognitively normal, have mild cognitive impairment, or have Alzheimer’s disease.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 354 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: Sinotau Pharmaceutical Group (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07115238 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 50 or older who can tolerate PET and MRI and fit one of the clinical groups: cognitively normal (CDR=0, MMSE≥28, Aβ‑PET negative), MCI due to AD (clinical MCI criteria with Aβ‑PET positive), or typical AD (clinical AD phenotype with Aβ‑PET positive).

Not a fit: People under 50, those who cannot undergo PET/MRI, those who do not meet the cognitive or Aβ‑PET criteria, or pregnant/breastfeeding individuals are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, XTR006 PET could let clinicians detect tau pathology more accurately in living patients, improving diagnosis, staging, and selection for therapies or trials.

How similar studies have performed: Other tau PET tracers (e.g., flortaucipir, MK‑6240) have shown promising correlations with postmortem tau pathology, but XTR006 is a newer tracer that still requires phase III validation.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality

• 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

Conditions Alzheimer Disease; Neurofibrillary Tangle