Alzheimer's Disease (AD)NCT07105956
Radiolabeled TSPO Targeted Molecular Probe in Alzheimer's Disease.
An observational study of Alzheimer's Disease (AD), run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Alzheimer's Disease (AD)
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 31 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants were recruited through hospital electronic records and community health centers
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Application of a Novel Radiolabeled Translocator Protein (TSPO) Targeted Small Molecular Probe in Neuroinflammation Imaging of Alzheimer's Disease.
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)
What is being measured
The primary outcome is the main question the study is designed to answer.
SUVmax of lesion uptake value
Measured: 60min after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's Disease (AD)Studies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Wang, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07105956
- Sponsor's protocol ID
- KY20250624-06-KS-01
- Status last verified
- Jul 2025
- First submitted
- 30 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of a Novel Radiolabeled Translocator Protein (TSPO) Targeted Small Molecular Probe in Neuroinflammation Imaging of Alzheimer's Disease.
- ClinicalTrials.gov ID
- NCT07105956
- Acronym / sponsor ID
- KY20250624-06-KS-01
- Conditions
- Alzheimer's Disease (AD)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants were recruited through hospital electronic records and community health centers
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
SUVmax of lesion uptake value
Time frame: 60min after administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease (AD), run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Feng Wang (+8602552271491, fengwangcn@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SUVmax of lesion uptake value (time frame: 60min after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.