NCT07115238 · Phase 3 · RECRUITING
Analysis of 18F-XTR006 PET Imaging in Cognitively Normal Subjects, and Patients With MCI and AD
This trial is testing a new PET imaging agent called XTR006, which is injected before a brain scan to help detect tau tangles — a hallmark of Alzheimer's damage — in people who are cognitively normal, have mild cognitive impairment, or have Alzheimer's disease. It is a Phase 3 trial, meaning researchers are evaluating how accurately this imaging tool identifies tau in the brain compared to a reference standard. It is a diagnostic tool, not a treatment.
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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-08-11