NCT07105956 · NOT YET RECRUITING

Radiolabeled TSPO Targeted Molecular Probe in Alzheimer's Disease.

This trial is testing a new PET imaging probe called 68Ga-DOTA-HK-011 that targets TSPO, a protein linked to brain inflammation. Researchers want to see how well it detects neuroinflammation in people already diagnosed with Alzheimer's disease. This is a diagnostic imaging study, not a treatment trial. The phase is unspecified, and details beyond the imaging objective are limited so far.

You may qualify if

  • Volunteer for the trial, with the patient or their legal guardian signing the informed consent form.
  • Volunteers are not limited by gender, and the age range is from 18 to 75 years old, including both ends.
  • The patient is diagnosed with Alzheimer's disease (AD), supported by a positive amyloid PET scan.
  • The patient has completed Tau PET scan.

You're excluded if

  • Individuals with a history of allergy to drugs chemically or biologically similar to TSPO, a history of atopy, or currently suffering from allergic diseases.
  • Use of anti-inflammatory drugs, including corticosteroids and immunosuppressants, within the past 14 days, which may interfere with the accuracy of inflammation imaging.
  • Presence of other coexisting neurological diseases, such as stroke, Parkinson's disease, brain tumors, or mental disorders, including depressive disorder and schizophrenia.
  • Severe cardiac, pulmonary, hepatic, or renal dysfunction, or uncontrolled systemic diseases; 5. Presence of metal implants contraindicated for MRI, including but not limited to cardiac pacemakers, artificial heart valves, and metal stents.
  • Claustrophobia or inability to tolerate prolonged examinations.
  • Pregnant women (defined as those with a positive urine pregnancy test) or breastfeeding women.
  • Patients whose physical condition is unsuitable for radioactive tracer-based imaging examinations.
  • Other circumstances deemed unsuitable for participation in the trial by the researcher.

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2025-08-06

View full record on ClinicalTrials.gov

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