Radiolabeled TSPO Targeted Molecular Probe in Alzheimer's Disease.

Nanjing Medical University

Status: Not yet enrolling

Conditions: Alzheimer's Disease (AD)

Study type: Observational

Funder types: Other

Identifiers

NCT07105956

KY20250624-06-KS-01

Details and patient eligibility

About

Evaluate the clinical application value of the novel radiolabeled TSPO-targeted molecular probe Gallium [68Ga]-DOTA-HK-011 in neuroinflammation imaging of Alzheimer's disease.

Enrollment: 8 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.