NCT07115238 Analysis of 18F-XTR006 PET Imaging in Cognitively Normal Subjects, and Patients With MCI and AD
| NCT ID | NCT07115238 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Sinotau Pharmaceutical Group |
| Condition | Alzheimer Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 354 participants |
| Start Date | 2024-11-20 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 354 participants in total. It began in 2024-11-20 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to evaluate the efficacy and safety of XTR006 injection PET visual reading in detecting brain neurofibrillary tangles (NFTs) in elderly subjects with Mild Cognitive Impairment (MCI), Alzheimer's Disease (AD), and cognitively normal individuals. The main question it aims to answer is: • What is the sensitivity and specificity of XTR006 PET visual reading results compared to the truth standard across MCI, AD, and cognitively normal subjects? Participants will: * Receive XTR006 injection * Undergo PET/CT scanning
Eligibility Criteria
Inclusion Criteria: Inclusion Criteria for All Subjects: 1. Male or female subjects aged ≥50 years. 2. Able to tolerate both PET and MRI examinations. 3. Must use contraceptive measures during the study period and for 6 months after study completion. 4. Written informed consent must be obtained before any assessment is performed. Inclusion Criteria for Cognitively Normal Subjects: 1)CDR (Clinical Dementia Rating) score of 0. 2）MMSE (Mini-Mental State Examination) score ≥28. 3）Negative visual reading result on brain Aβ-PET imaging. Inclusion Criteria for Subjects with MCI: 1. Meet the core clinical criteria for MCI due to AD according to 2011 NIA-AA (National Institute on Aging-Alzheimer's Association) standards 2. Positive visual reading result on brain Aβ-PET imaging Inclusion Criteria for Subjects with AD: 1. Meet the specific clinical phenotype criteria for typical AD according to 2014 International Working Group (IWG)-2 standards: 2. Positive visual reading result on brain Aβ-PET imaging. Exclusion Criteria: 1. Diagnosis of atypical AD, frontotemporal lobar degeneration (FTLD), Lewy body dementia, or other types of dementia. 2. Current significant psychiatric illness with symptoms that prevent completion of imaging procedures. 3. MRI-confirmed structural brain abnormalities, such as large stroke or intracranial mass lesions. 4. Claustrophobia. 5. History of alcohol abuse or drug abuse/dependence. 6. Allergy to the study drug or any of its components. 7. Women who are currently breastfeeding.
Contact & Investigator
Jiong Shi, Doctor
PRINCIPAL INVESTIGATOR
The First Affiliated Hospital of University of Science and Technology of China
Frequently Asked Questions
Who can join the NCT07115238 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Alzheimer Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07115238 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 354 participants.
Is NCT07115238 currently recruiting?
Yes, NCT07115238 is actively recruiting participants. Contact the research team at jshi2022@ystc.edu.cn for enrollment information.
Where is the NCT07115238 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07115238 clinical trial?
NCT07115238 is sponsored by Sinotau Pharmaceutical Group. The principal investigator is Jiong Shi, Doctor at The First Affiliated Hospital of University of Science and Technology of China. The trial plans to enroll 354 participants.
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