Alzheimer DiseasePhase 1NCT06151795
A Study to Evaluate XTR006 in Chinese Volunteers
A Phase 1 study testing XTR006 in people with Alzheimer Disease, run by Sinotau Pharmaceutical Group at 1 site in China.
Trial summary
XTR006 is a 18F-labeled positron emission tomography （PET）tracer for imaging tau protein in the brain. This phase I study investigated the safety, biodistribution, radiation dosimetry and Pharmacokinetics of XTR006 in 10 healthy elderly Chinese volunteers. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- 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
- 10 participants
- Where
- 1 siteChina
- Study dates
- 12 Jun 2023to 10 Jan 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female subjects between 50-70 years (included 50 \& 70 years old) will be included;
- Healthy or without serious diseases evaluated by the investigator based on the followings: medical history, vital signs, physical examination, electrocardiogram and clinical laboratory test results;
- Electroencephalogram（EEG）examination result is "normal";
- Aβ PET imaging is negative;
- Mini-Mental State Examination (MMSE) score ≥ 28;
- Normal routine blood and urine examination, liver function test, renal function test, biochemical test of serum troponin T and myocardial enzymes, or the abnormality of any test with no clinical significance;
- Female subjects must take effective contraceptive measures during the study period and within 6 months after the last visit (effective contraceptive measures include sterilization, intrauterine hormone devices, condoms, contraceptives/agents, abstinence or partner removal of the vas deferens, etc.). Male subjects should agree to take contraception during the study period and within 6 months after the last visit;
- Sign the informed consent form.
Who cannot join
- Any previously diagnosed brain disease, such as cerebrovascular disease, inflammatory or infectious disease or any neurodegenerative disease, including any history of Parkinson's disease by physical or imaging manifestations, or history of traumatic brain injury, history of brain surgery or cranial internal hematoma by permanent brain injury;
- Any history of severe diseases or undergoing unstable disease (such as unstable angina pectoris, dilated or hypertrophic cardiomyopathy, valvular heart disease, congenital heart disease, myocardial infarction, heart failure, chronic renal failure, chronic liver disease, severe lung disease, blood disease, diabetes, chronic infection, epilepsy, or mental illness);
- The result of cranial magnetic resonance imaging (MRI) met the following imaging criteria: ① More than two infarct regions (diameter greater than 2 cm) outside the brain stem. ② Critical lacunar infarction, such as thalamus, hippocampus, entorhinal cortex and angular gyrus. ③ Fazekas score of high white matter damage ≥ 3 or minor axis of enlarged perivascular space (EPVS) > 3 mm determined by MRI examination;
- Family history of dementia;
- Medication in the past week or at the present that may interfere the result of clinical trial evaluated by the investigator;
- Human immunodeficiency virus (HIV) hepatitis C or past test result of treponema pallidum antibody is positive, or hepatitis B surface antigen is positive;
Show all 18Show fewer
- History of coagulation disease or present coagulation disorder;
- History of liver or gastrointestinal diseases or other conditions that can interfere the drug absorption, distribution, excretion or metabolism evaluated by the investigator;
- Tumor history;
- High risk of drug allergy (such as allergic asthma patients) or history of severe reactions to allergens;
- Hyperreactive to alcohol;
- History of alcohol or drug abuse;
- Significant occupational exposure to ionizing radiation (e.g. more than 50 mSv/year), exposure to radioactive substances, ionizing radiation for therapeutic or research purposes in the past 10 years;
- Completion of any medicine or treatments that may cause serious side effects or interfere the clinical trial's data evaluated by the investigator;
- Participating other drug's clinical trial within 30 days before the enrollment;
- Pregnant or lactating female;
- Hospitalization due to illness during the screening period;
- Other inappropriateness to the trial evaluated by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study to Evaluate the Safety, Biodistribution, Radiation Dosimetry, and Pharmacokinetics of XTR006 in Healthy Chinese Volunteers
XTR006 is a 18F-labeled positron emission tomography （PET）tracer for imaging tau protein in the brain. This phase I study investigated the safety, biodistribution, radiation dosimetry and Pharmacokinetics of XTR006 in 10 healthy elderly Chinese volunteers.
Read the detailed description
XTR006 is a 18F-labeled PET tracer, for the quantification of neurofibrillary tangle (NFT) deposition in the brain. Brain NFT deposition is a pathologic finding in Alzheimer's Disease (AD), with brain NFT density shown to correlate with the severity of cognitive impairment in AD. This Phase I study will be open-labeled, nonrandomized, single center study. Enrolled 10 healthy elderly Chinese volunteers who meet all of the inclusion and none of the exclusion criteria. Subjects will receive 8-10mCi of XTR006 via IV injection. Safety and tolerability will be observed. Biodistribution, pharmacokinetics, and dosimetry will be investigated.
- Conditions
- Alzheimer Disease
- 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.
XTR006Diagnostic test
Single dose intravenous injection of XTR006. Serial whole-body PET scan will be obtain after injection, blood and urine collection after injection for the assessment of pharmacokinetics.
| Study group | Role | What they receive |
|---|---|---|
| XTR006 | Experimental | Single dose 8.0-10.0 mCi intravenous injection of XTR006 Receives: Diagnostic Test: XTR006 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events.
Safety Observation: Number of participants with adverse events and severe adverse events after drug injection.
Measured: up to 7 days post injection.
Secondary outcomes (1)
XTR006 Whole Body Effective Dose;
Radiation dose estimates measured in millisieverts per megabecquerel (mSv/MBq) for the whole body obtained from Organ Level Internal radiation dosimetry code.
Measured: up to 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start12 Jun 2023
- Primary completion27 Sep 2023
- Study completion10 Jan 2024
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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinotau Pharmaceutical Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- jianjun jia, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06151795
- Sponsor's protocol ID
- STB-XTR006-101
- Status last verified
- Nov 2023
- First submitted
- 7 Oct 2023
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety, Biodistribution, Radiation Dosimetry, and Pharmacokinetics of XTR006 in Healthy Chinese Volunteers
- ClinicalTrials.gov ID
- NCT06151795
- Acronym / sponsor ID
- STB-XTR006-101
- Conditions
- Alzheimer Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Sinotau Pharmaceutical GroupIndustry (pharma, biotech, devices)
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- 27 Sep 2023 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 30 Nov 2023 (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.
XTR006 is a 18F-labeled positron emission tomography （PET）tracer for imaging tau protein in the brain. This phase I study investigated the safety, biodistribution, radiation dosimetry and Pharmacokinetics of XTR006 in 10 healthy elderly Chinese volunteers.
Detailed description
XTR006 is a 18F-labeled PET tracer, for the quantification of neurofibrillary tangle (NFT) deposition in the brain. Brain NFT deposition is a pathologic finding in Alzheimer's Disease (AD), with brain NFT density shown to correlate with the severity of cognitive impairment in AD. This Phase I study will be open-labeled, nonrandomized, single center study. Enrolled 10 healthy elderly Chinese volunteers who meet all of the inclusion and none of the exclusion criteria. Subjects will receive 8-10mCi of XTR006 via IV injection. Safety and tolerability will be observed. Biodistribution, pharmacokinetics, and dosimetry will be investigated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| XTR006 | Experimental | Diagnostic Test: XTR006Single dose 8.0-10.0 mCi intravenous injection of XTR006 |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and female subjects between 50-70 years (included 50 \& 70 years old) will be included;
- Healthy or without serious diseases evaluated by the investigator based on the followings: medical history, vital signs, physical examination, electrocardiogram and clinical laboratory test results;
- Electroencephalogram（EEG）examination result is "normal";
- Aβ PET imaging is negative;
- Mini-Mental State Examination (MMSE) score ≥ 28;
Key exclusion criteria (18 listed)
- Any previously diagnosed brain disease, such as cerebrovascular disease, inflammatory or infectious disease or any neurodegenerative disease, including any history of Parkinson's disease by physical or imaging manifestations, or history of traumatic brain injury, history of brain surgery or cranial internal hematoma by permanent brain injury;
- Any history of severe diseases or undergoing unstable disease (such as unstable angina pectoris, dilated or hypertrophic cardiomyopathy, valvular heart disease, congenital heart disease, myocardial infarction, heart failure, chronic renal failure, chronic liver disease, severe lung disease, blood disease, diabetes, chronic infection, epilepsy, or mental illness);
- The result of cranial magnetic resonance imaging (MRI) met the following imaging criteria: ① More than two infarct regions (diameter greater than 2 cm) outside the brain stem. ② Critical lacunar infarction, such as thalamus, hippocampus, entorhinal cortex and angular gyrus. ③ Fazekas score of high white matter damage ≥ 3 or minor axis of enlarged perivascular space (EPVS) > 3 mm determined by MRI examination;
- Family history of dementia;
- Medication in the past week or at the present that may interfere the result of clinical trial evaluated by the investigator;
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 |
|---|---|---|
| XTR006Single dose intravenous injection of XTR006. Serial whole-body PET scan will be obtain after injection, blood and urine collection after injection for the assessment of pharmacokinetics. | Diagnostic test | XTR006 |
Primary outcome
Incidence of adverse events.
Time frame: up to 7 days post injection.
Safety Observation: Number of participants with adverse events and severe adverse events after drug injection.
1 secondary outcome
XTR006 Whole Body Effective Dose;
Time frame: up to 5 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Individual participant dataSharing planned: No
Related trials for Alzheimer Disease
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
Recruiting
Transcranial Alternating Current Stimulation (tACS) Combined With Cognitive Training in Alzheimer's Disease
Transcranial Alternating Current Stimulation, Alzheimer Disease (AD)
Not yet recruiting
Exercise in Alzheimer's Disease: Functional Biomarkers
Alzheimer's Dementia (AD), Alzheimer Disease (AD)
RecruitingObservational study
PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA)
Aging
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. This study is not recruiting at the moment.
jianjun jia principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing XTR006 in people with Alzheimer Disease, 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 8 inclusion and 18 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: finished, as of the sponsor's last update on 3 May 2024. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events. (time frame: up to 7 days post injection.). 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 3 May 2024.