Radiolabeled TSPO Targeted Molecular Probe in Alzheimer's Disease.

NCT07105956 | Not Yet Recruiting DMC

• 1 other identifier: KY20250624-06-KS-01
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alzheimer's Disease (AD)

Outcome Measures

Primary Outcomes (1)

• SUVmax of lesion uptake value

  60min after administration

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants were recruited through hospital electronic records and community health centers

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 may not qualify 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.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jingasu, 210006, China

Location

Central Study Contacts

Feng Wang

CONTACT

+8602552271491; fengwangcn@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 6, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: August 6, 2025

Record last verified: 2025-07

Locations

CN (1)