Alzheimer DiseasePhase 3NCT07115238
Analysis of 18F-XTR006 PET Imaging in Cognitively Normal Subjects, and Patients With MCI and AD
A Phase 3 study testing XTR006 in people with Alzheimer Disease and Neurofibrillary Tangle, run by Sinotau Pharmaceutical Group at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Neurofibrillary Tangle
- What is being tested?
- XTR006
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 354 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2024to 30 Jun 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- 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.
- Meet the core clinical criteria for MCI due to AD according to 2011 NIA-AA (National Institute on Aging-Alzheimer's Association) standards
Show all 9Show fewer
- 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:
- Positive visual reading result on brain Aβ-PET imaging.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100089
Ruiming PG Wang, Doctor, 13501151740, wrm@yeah.net
About this study
Official title: A Phase 3, Multicenter Study to Evaluate the Efficacy and Safety of PET Visual Assessment Using XTR006 Injection for Detection of Brain Neurofibrillary Tangles (NFTs) in Elderly Subjects
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
Read the detailed description
This is a multicenter, single-blind, non-randomized phase III study. The study aims to evaluate the effectiveness of XTR006 PET imaging visual reads for detecting NFTs in subjects. The trial procedures for all subjects include a screening period, an administration period, and a follow-up period. All subjects must sign an informed consent form before entering the screening period.
In this study, nuclear medicine physicians with tau-PET image reading experience will undergo training in the XTR006 PET visual reading methodology. Three nuclear medicine physicians who achieve excellent scores on the assessment will be selected as blinded visual readers for this study. All subject images will be visually interpreted in a blinded manner according to the XTR006 PET visual reading methodology. The final reading conclusion will be determined by consensus of at least two blinded visual readers. Using the composite diagnostic results of clinical cognitive assessment and Aβ-PET examination as the reference standard, sensitivity and specificity will be calculated with their 95% confidence intervals. The primary endpoint of this study will be considered achieved if the lower limit of the confidence interval exceeds the target value of 60%. Additionally, this study will analyze PET SUVR across groups to evaluate XTR006 uptake characteristics in different populations from a semi-quantitative perspective and assess the safety of XTR006 through analysis of post-administration AEs and SAEs.
- Conditions
- Alzheimer Disease, Neurofibrillary Tangle
- Being tested
- XTR006
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XTR006Drug
Also called [18F]MK 6240, Florquinitau
all 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.
| Study group | Role | What they receive |
|---|---|---|
| Alzheimer's Disease | Experimental | AD subjects will undergo PET imaging using [18F]XTR006. Receives: Drug: XTR006 |
| Mild Cognitive Impairment Due to Alzheimer's Disease | Experimental | MCI subjects will undergo PET imaging using [18F]XTR006. Receives: Drug: XTR006 |
| Cognitively normal | Experimental | Cognitively normal subjects will undergo PET imaging using [18F]XTR006. Receives: Drug: XTR006 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12month
Secondary outcomes (2)
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.
Measured: 12month
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).
Measured: 12month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start20 Nov 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 354 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinotau Pharmaceutical Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jiong Shi, Doctor, Principal investigator, The First Affiliated Hospital of University of Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07115238
- Sponsor's protocol ID
- STB-XTR006-301
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter Study to Evaluate the Efficacy and Safety of PET Visual Assessment Using XTR006 Injection for Detection of Brain Neurofibrillary Tangles (NFTs) in Elderly Subjects
- ClinicalTrials.gov ID
- NCT07115238
- Acronym / sponsor ID
- STB-XTR006-301
- Conditions
- Alzheimer Disease, Neurofibrillary Tangle
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 354 participants (estimated)
- Lead sponsor
- Sinotau Pharmaceutical GroupIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This is a multicenter, single-blind, non-randomized phase III study. The study aims to evaluate the effectiveness of XTR006 PET imaging visual reads for detecting NFTs in subjects. The trial procedures for all subjects include a screening period, an administration period, and a follow-up period. All subjects must sign an informed consent form before entering the screening period.
In this study, nuclear medicine physicians with tau-PET image reading experience will undergo training in the XTR006 PET visual reading methodology. Three nuclear medicine physicians who achieve excellent scores on the assessment will be selected as blinded visual readers for this study. All subject images will be visually interpreted in a blinded manner according to the XTR006 PET visual reading methodology. The final reading conclusion will be determined by consensus of at least two blinded visual readers. Using the composite diagnostic results of clinical cognitive assessment and Aβ-PET examination as the reference standard, sensitivity and specificity will be calculated with their 95% confidence intervals. The primary endpoint of this study will be considered achieved if the lower limit of the confidence interval exceeds the target value of 60%. Additionally, this study will analyze PET SUVR across groups to evaluate XTR006 uptake characteristics in different populations from a semi-quantitative perspective and assess the safety of XTR006 through analysis of post-administration AEs and SAEs.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alzheimer's Disease | Experimental | Drug: XTR006AD subjects will undergo PET imaging using [18F]XTR006. |
| Mild Cognitive Impairment Due to Alzheimer's Disease | Experimental | Drug: XTR006MCI subjects will undergo PET imaging using [18F]XTR006. |
| Cognitively normal | Experimental | Drug: XTR006Cognitively normal subjects will undergo PET imaging using [18F]XTR006. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XTR006Also: [18F]MK 6240, Florquinitauall 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. | Drug | Alzheimer's Disease, Cognitively normal, Mild Cognitive Impairment Due to Alzheimer's Disease |
Primary outcome
Evaluate the effectiveness of visual reading of XTR006 PET imaging in detecting tau NFTs (neurofibrillary tangles)
Time frame: 12month
The sensitivity and specificity of XTR006 PET imaging visual reading results compared to the truth standard.
2 secondary outcomes
Compare the overall brain uptake patterns of XTR006 in MCI (Mild Cognitive Impairment), AD (Alzheimer's Disease), and cognitively normal subjects.
Time frame: 12month
Safety and Tolerability Profile Measured by Adverse Events (AEs)
Time frame: 12month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jiong Shi, Doctor principal investigator
The First Affiliated Hospital of University of Science and Technology of China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing XTR006 in people with Alzheimer Disease and Neurofibrillary Tangle, run by Sinotau Pharmaceutical Group at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiong Shi, Doctor (15512191857, jshi2022@ystc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the effectiveness of visual reading of XTR006 PET imaging in detecting tau NFTs (neurofibrillary tangles) (time frame: 12month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.