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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
XTR006
Drugall patients will receive one injection of \[18F\]XTR006, a PET radiopharmaceutical selective for NFTs. For the injection, subjects will receive a target dose of 4-6 mCi IV as a bolus injection. \[18F\]XTR006 injection will be followed by a 10 ml saline flush.
Treatment groups
354 Participants
are divided into 3 treatment groupsGroup A: Alzheimer's DiseaseExperimental treatment 1 intervention
Group B: Mild Cognitive Impairment Due to Alzheimer's DiseaseExperimental treatment 1 intervention
Group C: Cognitively normalExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Evaluate the effectiveness of visual reading of XTR006 PET imaging in detecting tau NFTs (neurofibrillary tangles)
The sensitivity and specificity of XTR006 PET imaging visual reading results compared to the truth standard.
Time frame
12monthSecondary outcomes
1
Compare the overall brain uptake patterns of XTR006 in MCI (Mild Cognitive Impairment), AD (Alzheimer's Disease), and cognitively normal subjects.
The inter-group differences in XTR006 PET Standardized Uptake Value Ratios (SUVR) within brain regions of interest(ROIs) among different subject groups；The sensitivity and specificity of semi-quantitative SUVR analysis in differentiating between different subject groups.
Time frame
12month2
Safety and Tolerability Profile Measured by Adverse Events (AEs)
Safety and tolerability profile for the administration of \[18F\]XTR006 and PET scanning are measured by number of participants with adverse events (AEs).
Time frame
12monthSponsors and contacts
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Source ClinicalTrials.gov