Analysis of 18F-XTR006 PET Imaging in Cognitively Normal Subjects, and Patients With MCI and AD
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age50+
SponsorSinotau Pharmaceutical Group
About this trial
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
Qualifiers
Male or female subjects aged ≥50 years.
Able to tolerate both PET and MRI examinations.
Must use contraceptive measures during the study period and for 6 months after study completion.
Written informed consent must be obtained before any assessment is performed.
Disqualifiers
Diagnosis of atypical AD, frontotemporal lobar degeneration (FTLD), Lewy body dementia, or other types of dementia.
Current significant psychiatric illness with symptoms that prevent completion of imaging procedures.
MRI-confirmed structural brain abnormalities, such as large stroke or intracranial mass lesions.
Claustrophobia.
Trial design
Treatments tested in this trial
- XTR006
Treatment groups
354 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov