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New treatment option for Alzheimer Disease
Official title Analysis of 18F-XTR006 PET Imaging in Cognitively Normal Subjects, and Patients With MCI and AD
ClinicalTrials.gov ID: NCT07115238
What this study is testing
What is XTR006?
XTR006 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for alzheimer disease.
Also referred to as [18F]MK 6240, Florquinitau.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older. Healthy volunteers may be eligible.
You may be able to join if
- for All people:
- Male or female people 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. for Cognitively Normal people: 1)CDR (Clinical Dementia Rating) score...
You likely can't join if
- 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.
- History of alcohol abuse or drug abuse/dependence.
- Allergy to the study drug or any of its components.
See the full eligibility criteria
- for All people:
- Male or female people 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. for Cognitively Normal people: 1)CDR (Clinical Dementia Rating) score of 0. 2）MMSE (Mini-Mental State Examination) score ≥28. 3）Negative...
- 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 for people with AD:
- Meet the specific clinical phenotype criteria for typical AD according to 2014 International Working Group (IWG)-2 standards:
- Positive visual reading result on brain Aβ-PET imaging.
- 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.
- History of alcohol abuse or drug abuse/dependence.
- Allergy to the study drug or any of its components.
- Women who are currently breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.