Positron Emission TomographyNCT06148233
CSF1R PET Probe [18F]CSF-23 in Alzheimer's Disease Brain Imaging
A study testing [18F]CSF-23 in people with Positron Emission Tomography and Alzheimer Disease, run by Huashan Hospital at 1 site in China.
Trial summary
To explore the diagnostic value of [18F]CSF-23 brain imaging for CSF1R expression in Alzheimer's disease. PET imaging with this PET tracer was used to assess the role and expression of CSF1R in AD and to evaluate the level and safety of abnormal present imaging. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Positron Emission Tomography, Alzheimer Disease, Neurodegenerative Diseases
- What is being tested?
- [18F]CSF-23
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2023to 14 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non-diseased controls:
- Between 60 and 80 years of age; gender is not limited.
- Cognitively normal as determined by the investigator through testing, with an MMSE score greater than 25 and no cognitive domain impairment. They had a negative Aβ image.
- No neurological diseases, major chronic diseases, malignant tumors, or acute infectious diseases, as determined by the investigator.
- Written informed consent must be signed by the subject or his/her legal guardian or caregiver.
- Blood routine: white blood cell count (WBC) 4~10×109/L; platelet (PLT) 100~300×109/L; hemoglobin (HB) 120~160 g/L; renal function: serum creatinine less than or equal to the upper limit of the normal range; hepatic function: bilirubin, AST (SGOT)/ALT (SGPT) less than or equal to the upper limit of the normal range; Electrocardiogram: no significant abnormalities.
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- No neurological diseases, major chronic diseases, malignant tumors, or acute infectious diseases, as confirmed by the investigator; no family history of neurodegenerative movement disorders, and no family history of neurological disorders related to movement disorders.
- Willingness and ability to cooperate with all programs of this study.
- AD patients:
- Age between 60 and 80 years old; gender is not limited.
- Patients meet the 2011 NIA-AA diagnostic criteria for red AD patients and have positive Aβ images.
- Brain MRI supported the diagnosis of AD and there was no evidence of other neurological diseases.
- No neurological diseases, major chronic diseases, malignant tumors or acute infectious diseases, etc., as confirmed by the investigator.
- Written informed consent must be signed by the subject or his/her legal guardian or caregiver.
- Blood routine: white blood cell count (WBC) 4~10×109/L; platelet (PLT) 100~300×109/L; hemoglobin (HB) 120~160 g/L; renal function: serum creatinine less than or equal to the upper limit of the normal range; hepatic function: bilirubin, AST (SGOT)/ALT (SGPT) less than or equal to the upper limit of the normal range; ECG: no significant abnormalities.
- No neurological diseases, major chronic diseases, malignant tumors, or acute infectious diseases, as confirmed by the investigator; no family history of neurodegenerative movement disorders, and no family history of neurological disorders related to movement disorders.
- Willingness and ability to cooperate with all programs of this study.
Who cannot join
- Subjects meeting any of the following criteria will be excluded from the study:
- Severe hepatic or renal insufficiency;
- Participation in other research protocols or clinical care within the past year, in addition to the radiation exposure expected from participation in this clinical study, which has resulted in radiation exposure in excess of an effective dose of 50 mSv.
- Liver function: bilirubin, AST(SGOT)/ALT(SGPT) less than or equal to the upper limit of the normal range.
- History of serious surgery in the last month.
- Participation in other clinical trials during the same period.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital
Shanghai, 200040
Yihui Guan, MD, 13764308300 ext. +86, guanyihui@hotmail.com
About this study
To explore the diagnostic value of [18F]CSF-23 brain imaging for CSF1R expression in Alzheimer's disease. PET imaging with this PET tracer was used to assess the role and expression of CSF1R in AD and to evaluate the level and safety of abnormal present imaging.
- Being tested
- [18F]CSF-23
- Medical subject headings
- Alzheimer Disease, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]CSF-23Radiation
Intravenous injection of 1.8 MBq [0.05MCi]/kg of [18F]CSF-23 in a single dose.
| Study group | Role | What they receive |
|---|---|---|
| patients with Alzheimer's Disease | Experimental | AD subjects recruited from geriatric wards or memory clinics. Receives: Radiation: [18F]CSF-23 |
| Cognitively normal control group | Experimental | Cognitively normal subjects recruited from the community Receives: Radiation: [18F]CSF-23 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete PET imaging
To assess the diagnostic value of [18F]CSF-23 brain imaging for CSF1R expression in Alzheimer's disease.
Measured: 90mins from time of injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start15 Sep 2023
- Primary completion16 Jun 2024 (estimated)
- Study completion14 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Positron Emission TomographyStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YiHui Guan, Huashan Hospital
- Investigators
- Fang Xie, PhD, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06148233
- Sponsor's protocol ID
- KY2023-780
- Status last verified
- Nov 2023
- First submitted
- 19 Nov 2023
- Last updated
- 28 Nov 2023
- 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 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSF1R PET Probe [18F]CSF-23 in Alzheimer's Disease Brain Imaging
- ClinicalTrials.gov ID
- NCT06148233
- Acronym / sponsor ID
- KY2023-780
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 16 Jun 2024 (estimated)
- Study completion
- 14 Sep 2024 (estimated)
- First posted
- 28 Nov 2023 (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.
To explore the diagnostic value of [18F]CSF-23 brain imaging for CSF1R expression in Alzheimer's disease. PET imaging with this PET tracer was used to assess the role and expression of CSF1R in AD and to evaluate the level and safety of abnormal present imaging.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with Alzheimer's Disease | Experimental | Radiation: [18F]CSF-23AD subjects recruited from geriatric wards or memory clinics. |
| Cognitively normal control group | Experimental | Radiation: [18F]CSF-23Cognitively normal subjects recruited from the community |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Non-diseased controls:
- Age between 60 and 80 years old; gender is not limited.
- Patients meet the 2011 NIA-AA diagnostic criteria for red AD patients and have positive Aβ images.
- Brain MRI supported the diagnosis of AD and there was no evidence of other neurological diseases.
- No neurological diseases, major chronic diseases, malignant tumors or acute infectious diseases, etc., as confirmed by the investigator.
Key exclusion criteria (6 listed)
- Subjects meeting any of the following criteria will be excluded from the study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]CSF-23Intravenous injection of 1.8 MBq [0.05MCi]/kg of [18F]CSF-23 in a single dose. | Radiation | Cognitively normal control group, patients with Alzheimer's Disease |
Primary outcome
Complete PET imaging
Time frame: 90mins from time of injection
To assess the diagnostic value of [18F]CSF-23 brain imaging for CSF1R expression in Alzheimer's disease.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
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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. This study is not recruiting at the moment.
Fang Xie, PhD principal investigator
Huashan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [18F]CSF-23 in people with Positron Emission Tomography and Alzheimer Disease, run by Huashan Hospital 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 17 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 28 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yihui Guan, MD (13764308300 ext. +86, guanyihui@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete PET imaging (time frame: 90mins from time of injection). 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 28 Nov 2023.