Not yet recruiting NCT07105956
Radiolabeled TSPO Targeted Molecular Probe in Alzheimer's Disease.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Alzheimer's Disease (AD). Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Application of a Novel Radiolabeled Translocator Protein (TSPO) Targeted Small Molecular Probe in Neuroinflammation Imaging of Alzheimer's Disease.
Overview
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.
Primary outcome measures
- SUVmax of lesion uptake value [Time frame: 60min after administration]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Nanjing First Hospital — Nanjing
Identifiers
NCT: NCT07105956 · KY20250624-06-KS-01