Analysis of 18F-XTR006 PET Imaging in Cognitively Normal Subjects, and Patients With MCI and AD (NCT07115238) | Clinical Trial Compass
RecruitingPhase 3
Analysis of 18F-XTR006 PET Imaging in Cognitively Normal Subjects, and Patients With MCI and AD
China354 participantsStarted 2024-11-20
Plain-language 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
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Meet the core clinical criteria for MCI due to AD according to 2011 NIA-AA (National Institute on Aging-Alzheimer's Association) standards
. Positive visual reading result on brain Aβ-PET imaging
. Meet the specific clinical phenotype criteria for typical AD according to 2014 International Working Group (IWG)-2 standards:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluate the effectiveness of visual reading of XTR006 PET imaging in detecting tau NFTs (neurofibrillary tangles)