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