Radiolabeled TSPO Targeted Molecular Probe in Alzheimer's Disease.

NCT ID: NCT07105956

Last Updated: 2025-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-01

Study Completion Date

2026-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer's Disease (AD)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Feng Wang

Chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Nanjing First Hospital

Nanjing, Jingasu, China

Site Status

Countries

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China

Central Contacts

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Feng Wang

Role: CONTACT

+8602552271491

Other Identifiers

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KY20250624-06-KS-01

Identifier Type: -

Identifier Source: org_study_id

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