Alzheimer DiseaseNCT05260151
Tau Protein and SV2a Imaging in Patients With Tau Protein-related Diseases
An observational study of Alzheimer Disease and Progressive Supranuclear Palsy, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
Tau protein has been identified as one of the key pathological features of Tau proteinopathies, such as Alzheimer's disease (AD), progressive supranuclear palsy (PSP), frontotemporal dementia (FTD). Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Progressive Supranuclear Palsy, Frontotemporal Dementia
- How many people
- 155 participants
- Where
- 1 siteChina
- Study dates
- 18 Nov 2020to 31 Dec 2022
- Phase
- Observational
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects will be separated into two groups: AD group and Non-AD group. Among them, AD group will include cognitive normal controls, prodromal Alzheimer's disease patients and mild Alzheimer's disease patients. Non-AD group will include patients with progressive supranuclear palsy (PSP) , patients with frontotemporal dementia (FTD) carrying MAPT gene, patients with FTD without MAPT gene (carrying other FTD related genes such as C9Orf, Progranulin, CHCHD10 or svPPA with TDP43 gene), non-symptomatic carriers with MAPT mutation and normal controls.
Who may be able to join
- Males and females aged 40 to 80 years.
- Females have no fertility due to surgery or at least one year after menopause. Otherwise, pregnancy tests should be conducted during screening and every scan visit and should be negative. Males with fertility must use two methods of contraception during the study period and one of them should be barrier contraception. No sperm donation is allowed during the study period and within 90 days after the completion of this study.
- The subject and the subject's legally authorized representative or caregiver should be willing and able to cooperate during the whole research process. According to the judgement of the researcher, there can be a research companion who has regular and sufficient contact with the subjects (spend more than 10 hours a week together). The companion can provide accurate information about the cognitive and functional aspects of the subject, and agrees to accompany the subjects and provide relevant information during the visits. Research companions must be confirmed by researchers that they have sufficient cognitive ability to accurately report subjects' behavior, cognition and function, and can accompany throughout the whole research process with subjects.
- Researchers believe that the subject can complete all the relevant contents of this study.
Who cannot join
- Current or prior history of any alcohol or drug abuse within the past 3 years (self report).
- Laboratory tests or ECG with clinically significant abnormalities and/or clinically significant unstable medical illness.
- Radiation exposure received from clinical care prior participation in the last year, combined with that from the present study, exceeds an effective dose of 50 mSV.
- Pregnant, lactating or breastfeeding or intention to become pregnant.
- Evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological, immunodeficiency (including a positive HIV result), pulmonary, or other disorder or disease. Stable, treated chronic medical conditions like hypertension, hypercholesterolemia, diabetes mellitus, non-metastatic dermatologic or prostatic cancer, etc. are acceptable as long as they do not, in the investigator's opinion, contribute to cognitive dysfunction or limit participation in study procedures.
- In the opinion of the investigator, unsuitable to complete lumbar puncture. For example: history of vertebral deformities, major lumbar back surgery, clinically significant back pain, clinically significant abnormal x-ray, and/or injury or taking blood thinners or lab results that would preclude the subject/patient participation or CSF collection during study.
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- MRI exclusion criteria include: findings that may impact cognition such as significant evidence of cerebrovascular disease (more than two lacunar infarcts, any territorial infarct >1cm3, or deep white matter abnormality corresponding to an overall Fazekas scale of 3, with at least one confluent hyperintense lesion on the FLAIR sequence that is ≥20 mm in any dimension), infectious disease, space-occupying lesion, normal pressure hydrocephalus, CNS trauma, or any other structural abnormality that may impact cognition.
- Veins are not suitable for repeated puncture.
- Implants such as implanted cardiac pacemakers or defibrillators, insulin pumps, cochlear implants, metallic ocular foreign body, implanted neural stimulators, CNS aneurysm clips and other medical implants that have not been certified for MRI, or history of claustrophobia in MRI.
- Daily treatment with anticholinergic antidepressants, typical antipsychotics, or barbiturates, daily treatment with benzodiazepines, opiates, or opioids; treatment with soporifics, stimulants, atypical antipsychotics, centrally acting anticholinergic antihistamines, or centrally acting anticholinergic antispasmodics is prohibited, unless administered intermittently and on a short-term basis and not used within 5 half-lives prior to screening or any neurocognitive assessment.
- Treatment with soporifics, stimulants, atypical antipsychotics, centrally acting anticholinergic antihistamines, or centrally acting anticholinergic antispasmodics is prohibited unless (a) administered daily that initiation or discontinuation of therapy or dose change does not occur within 5 half-lives prior to screening or at any point during the study, or (b) administered intermittently and on a short-term basis and not used within 5 half-lives prior to screening or any neurocognitive assessment.
- Treatment with any therapeutic molecule or treatment that targets Aβ or Tau within 12 months prior to screening.
- Have participated in a clinical trial within 30 days prior to screening or within 5 half-lives since last administration of investigational drug (whichever is greater).
- Researchers consider that other diseases or causes might prevent subjects from completing the entire study.
- Others that do not meet the specific inclusion/exclusion criteria of each part of this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital
Beijing, Beijing Municipality, 100053
Biao Chen, MD
About this study
Official title: Cross-sectional Validation and Longitudinal Study of Tau Protein and SV2a Imaging in Patients With Tau Protein-related Diseases and Normal Controls
Tau protein has been identified as one of the key pathological features of Tau proteinopathies, such as Alzheimer's disease (AD), progressive supranuclear palsy (PSP), frontotemporal dementia (FTD). Tau protein-targeted PET imaging can detect the amount and distribution of Tau protein deposition in human body, and has great research and application value in the diagnosis and evaluation of Tau protein disease. This study will be the first to introduce a complete quantitative, repeatable detection and analysis method in China. For the SV2a tracer [18F]MNI-1126, cross-sectional evaluation of its imaging in patients with Tau protein-related diseases and normal controls will be carried out. Later, longitudinal clinical symptoms and two tracers will be evaluated in patients with Tau protein-related diseases and normal controls.([18F]APN1607 and [18F]MNI1126) Imaging follow-up to explore longitudinal changes in brain Tau protein deposition and synaptic density in Tau protein-related diseases, thus providing support for future clinical drug trials using imaging biomarkers.
Read the detailed description
Tau protein has been identified as one of the key pathological features of Tau protein diseases such as Alzheimer's disease (AD), progressive supranuclear palsy (PSP), frontotemporal dementia (FTD). Tau protein targeting PET imaging can detect the amount and distribution of Tau protein deposition in human body. It has significant research and application value in diagnosis and evaluation for Tau protein diseases. Previous studies have shown that Tau radiotracer can detect Tau pathology in early stage of AD, and Tau signal increases as the disease progresses. In addition, Tau binding may be associated with increased cognitive impairment in AD subjects. [18F] APN-1607 is a newly developed PET imaging agent targeting to Tau protein, which has high affinity with Tau protein in brain tissue of AD patients, high selectivity for Aβ protein, MAO-A and MAO-B, and no non-specific uptake in normal brain tissue. Toxicological studies show that intravenous injection of [18F] APN-1607 with dosage less than 20μg is safe. Its clinical research has been initiated in the United States, Japan and Taiwan.
Synaptic vesicle glycoprotein 2 (SV2) is a membrane protein in presynaptic envelope. SV2 is an important component of normal synaptic function and plays an important role in neurotransmitter release. Three isomers of SV2 are known, of which SV2A is the only subtype distributed throughout the brain. Studies have shown that synaptic loss in hippocampus and cerebral cortex is closely related to cognitive impairment in Alzheimer's disease. Therefore, PET imaging and quantification of SV2A signal may be an excellent representative of synaptic density in vivo, which can be used to measure the brain level of SV2A in Alzheimer's disease, Parkinson's disease or other neurological and psychiatric diseases, and potentially as a biomarker of synaptic density in neurodegenerative diseases. Researchers have reported the development and evaluation of 18F labeled tracers for SV2A protein imaging. The best candidate [18F] MNI-1126 has shown excellent in vivo binding properties in preliminary studies in non-human primates. These preliminary in vivo pre-clinical evaluations suggest that [18F] MNI-1126 exhibits excellent quality as a F-18 labeled PET tracer for multicenter SV2A imaging trials.
The greatest advantage of PET imaging technology is that it can visualize the structure or function of tissues and organs which could not be observed in vivo without trauma. Visual observation of the distribution of radioactivity concentration in PET images can qualitatively distinguish the positive and negative cases. Standard uptake value ratio (SUVR) can be used to semi-quantitatively analyze the abnormal uptake of a region of interest in patients for clinical and daily work. However, in the development of new molecular targeting markers, in order to make better use of the information in images to obtain the parameters and contents of molecular markers such as distribution, miss targeting or not, condition for blood-brain barrier passage ,and stability, a complete set of quantitative and repetitive detection and analysis methods should be applied. It includes detection of radioactivity in arterial blood, detection of metabolites of molecular markers, dynamic modeling of PET, repeated measurement and analysis, and so on.
Measuring radioactive activity of arterial blood is a method to obtain the input parameters of molecular targeted markers in the brain by detecting the radioactivity of per unit volume in arterial blood at multiple time points. High Performance Liquid Chromatography (HPLC) can be used to detect the metabolites of molecular markers with radioactivity, which can be used to calibrate the total radioactivity of arterial blood samples and obtain the concentration of free molecular targeted markers in arterial plasma. On the basis of acquiring the input parameters of brain molecular targeting markers, the dynamic behavior of a given PET tracer can be described by establishing a dynamic model of radiotracer and estimating the relevant parameters. The required data can be obtained under the minimum possible traumatic conditions, and then the parameters related to physiological, biochemical or metabolic processes can be quantitatively estimated. Then through repeated measurements of brain molecular targeting markers, that is, multiple scans of the same molecular marker and the same patient at different time points, the results of the two scans can be qualitatively and quantitatively analyzed and compared, and the pharmacokinetics of the markers in the brain, the properties of binding targets and the stability between batches can be further obtained. However, because of the intolerance of patients and other factors in the study of arterial blood radioactivity detection and repeated measurement for radioactive markers, although it is a mature PET-related research technology around the world, it has not been effectively carried out in China.
In this study, we will introduce a complete quantitative and repetitive analysis method for the first time in China to evaluate the cross-sectional imaging of Tau protein tracer [18F]APN-1607 and SV2a tracer [18F] MNI-1126 in patients with Tau protein-related diseases and normal controls. Subsequently, the longitudinal changes of Tau protein deposition and synaptic density in the brain of patients with Tau protein-related diseases will be explored through the evaluation of longitudinal clinical symptoms and follow-up of two kinds of tracer ([18F]APN1607 and [18F]MNI1126) imaging in patients with Tau protein-related diseases and normal controls, so as to provide support for the design of clinical trials using imaging biomarkers in the future.
- Keywords
- Tau, SV2A, PET imaging
- Medical subject headings
- Alzheimer Disease, Supranuclear Palsy, Progressive, Frontotemporal Dementia, Pick Disease of the Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cross-sectional validation study | Each tracer's study will enroll 5 normal controls and 5 cases for each relevant disease, which means [18F]APN-1607 imaging with arterial line will be performed in 5 normal controls, 15 patients with Alzheimer's disease patients, progressive supranuclear palsy (PSP) and frontotemporal dementia (FTD), and [18F] MNI-1126 imaging with Aline test will be performed in 5 normal controls, 15 patients with Alzheimer's disease, progressive supranuclear palsy (PSP) and frontotemporal dementia (FTD); a total of 40 patients will be enrolled in this study group. Patients may choose to participate in the cross-sectional validation study for both tracers, or only for one of them. | |
| Longitudinal study | A total of 115 patients are planned to be enrolled in the study. Among them, AD group will enroll 10 cognitive normal controls, 15 prodromal Alzheimer's disease patients and 15 mild Alzheimer's disease patients. Non-AD group will enroll 15 patients with progressive supranuclear palsy (PSP) , 15 patients with frontotemporal dementia (FTD) carrying MAPT gene, 15 patients with FTD without MAPT gene (carrying other FTD related genes such as C9Orf, Progranulin, CHCHD10 or svPPA with TDP43 gene), 15 non-symptomatic carriers with MAPT mutation and 15 normal controls. Subjects who participated in cross-sectional validation study could also participate in this longitudinal study. Patients may also choose to participate only in the longitudinal study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference of Tau protein deposition and SV2a protein between patients with Tau protein-related diseases and healthy controls
through the distribution characteristics, time activity curves and kinetic parameters of the tracers in different populations, and to find out the key imaging parameters related to clinical symptoms.
Measured: March 2020 to December 2022.
To evaluate the longitudinal changes of Tau deposition and SV2a in patients with Tau-related diseases and healthy volunteers
Changes in each SUVR value or Tau and SV2a distribution were observed in subjects and healthy controls with different diseases
Measured: March 2020 to December 2022.
To evaluate the correlation between the longitudinal changes of the deposition of Tau and SV2a
clinical symptoms, MRI and serum biomarkers in patients with Tau-related diseases and healthy volunteers.
Measured: March 2020 to December 2022.
AE events
AE events after the subject scan were determined to evaluate the safety of [18F]APN-1607 and [18F]MNI-1126.
Measured: March 2020 to December 2022.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start18 Nov 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (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.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 155 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- XingImaging, LLC, H. Lundbeck A/S, Millennium Pharmaceuticals, Inc., Hoffmann-La Roche, Biogen, Hangzhou G-Bio Biotechnology Co., Ltd
- Responsible party
- Principal investigator, Piu Chan, Xuanwu Hospital, Beijing
- Investigators
- Biao Chen, M.D., Ph.D, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05260151
- Sponsor's protocol ID
- 2019SQGH5295
- Status last verified
- Feb 2022
- First submitted
- 13 Aug 2020
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-sectional Validation and Longitudinal Study of Tau Protein and SV2a Imaging in Patients With Tau Protein-related Diseases and Normal Controls
- ClinicalTrials.gov ID
- NCT05260151
- Acronym / sponsor ID
- 2019SQGH5295
- Keywords
- Tau, SV2A, PET imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- XingImaging, LLC, H. Lundbeck A/S, Millennium Pharmaceuticals, Inc., Hoffmann-La Roche, Biogen, Hangzhou G-Bio Biotechnology Co., Ltd
- Study start
- 18 Nov 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 2 Mar 2022 (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.
Tau protein has been identified as one of the key pathological features of Tau proteinopathies, such as Alzheimer's disease (AD), progressive supranuclear palsy (PSP), frontotemporal dementia (FTD). Tau protein-targeted PET imaging can detect the amount and distribution of Tau protein deposition in human body, and has great research and application value in the diagnosis and evaluation of Tau protein disease. This study will be the first to introduce a complete quantitative, repeatable detection and analysis method in China. For the SV2a tracer [18F]MNI-1126, cross-sectional evaluation of its imaging in patients with Tau protein-related diseases and normal controls will be carried out. Later, longitudinal clinical symptoms and two tracers will be evaluated in patients with Tau protein-related diseases and normal controls.([18F]APN1607 and [18F]MNI1126) Imaging follow-up to explore longitudinal changes in brain Tau protein deposition and synaptic density in Tau protein-related diseases, thus providing support for future clinical drug trials using imaging biomarkers.
Detailed description
Tau protein has been identified as one of the key pathological features of Tau protein diseases such as Alzheimer's disease (AD), progressive supranuclear palsy (PSP), frontotemporal dementia (FTD). Tau protein targeting PET imaging can detect the amount and distribution of Tau protein deposition in human body. It has significant research and application value in diagnosis and evaluation for Tau protein diseases. Previous studies have shown that Tau radiotracer can detect Tau pathology in early stage of AD, and Tau signal increases as the disease progresses. In addition, Tau binding may be associated with increased cognitive impairment in AD subjects. [18F] APN-1607 is a newly developed PET imaging agent targeting to Tau protein, which has high affinity with Tau protein in brain tissue of AD patients, high selectivity for Aβ protein, MAO-A and MAO-B, and no non-specific uptake in normal brain tissue. Toxicological studies show that intravenous injection of [18F] APN-1607 with dosage less than 20μg is safe. Its clinical research has been initiated in the United States, Japan and Taiwan.
Synaptic vesicle glycoprotein 2 (SV2) is a membrane protein in presynaptic envelope. SV2 is an important component of normal synaptic function and plays an important role in neurotransmitter release. Three isomers of SV2 are known, of which SV2A is the only subtype distributed throughout the brain. Studies have shown that synaptic loss in hippocampus and cerebral cortex is closely related to cognitive impairment in Alzheimer's disease. Therefore, PET imaging and quantification of SV2A signal may be an excellent representative of synaptic density in vivo, which can be used to measure the brain level of SV2A in Alzheimer's disease, Parkinson's disease or other neurological and psychiatric diseases, and potentially as a biomarker of synaptic density in neurodegenerative diseases. Researchers have reported the development and evaluation of 18F labeled tracers for SV2A protein imaging. The best candidate [18F] MNI-1126 has shown excellent in vivo binding properties in preliminary studies in non-human primates. These preliminary in vivo pre-clinical evaluations suggest that [18F] MNI-1126 exhibits excellent quality as a F-18 labeled PET tracer for multicenter SV2A imaging trials.
The greatest advantage of PET imaging technology is that it can visualize the structure or function of tissues and organs which could not be observed in vivo without trauma. Visual observation of the distribution of radioactivity concentration in PET images can qualitatively distinguish the positive and negative cases. Standard uptake value ratio (SUVR) can be used to semi-quantitatively analyze the abnormal uptake of a region of interest in patients for clinical and daily work. However, in the development of new molecular targeting markers, in order to make better use of the information in images to obtain the parameters and contents of molecular markers such as distribution, miss targeting or not, condition for blood-brain barrier passage ,and stability, a complete set of quantitative and repetitive detection and analysis methods should be applied. It includes detection of radioactivity in arterial blood, detection of metabolites of molecular markers, dynamic modeling of PET, repeated measurement and analysis, and so on.
Measuring radioactive activity of arterial blood is a method to obtain the input parameters of molecular targeted markers in the brain by detecting the radioactivity of per unit volume in arterial blood at multiple time points. High Performance Liquid Chromatography (HPLC) can be used to detect the metabolites of molecular markers with radioactivity, which can be used to calibrate the total radioactivity of arterial blood samples and obtain the concentration of free molecular targeted markers in arterial plasma. On the basis of acquiring the input parameters of brain molecular targeting markers, the dynamic behavior of a given PET tracer can be described by establishing a dynamic model of radiotracer and estimating the relevant parameters. The required data can be obtained under the minimum possible traumatic conditions, and then the parameters related to physiological, biochemical or metabolic processes can be quantitatively estimated. Then through repeated measurements of brain molecular targeting markers, that is, multiple scans of the same molecular marker and the same patient at different time points, the results of the two scans can be qualitatively and quantitatively analyzed and compared, and the pharmacokinetics of the markers in the brain, the properties of binding targets and the stability between batches can be further obtained. However, because of the intolerance of patients and other factors in the study of arterial blood radioactivity detection and repeated measurement for radioactive markers, although it is a mature PET-related research technology around the world, it has not been effectively carried out in China.
In this study, we will introduce a complete quantitative and repetitive analysis method for the first time in China to evaluate the cross-sectional imaging of Tau protein tracer [18F]APN-1607 and SV2a tracer [18F] MNI-1126 in patients with Tau protein-related diseases and normal controls. Subsequently, the longitudinal changes of Tau protein deposition and synaptic density in the brain of patients with Tau protein-related diseases will be explored through the evaluation of longitudinal clinical symptoms and follow-up of two kinds of tracer ([18F]APN1607 and [18F]MNI1126) imaging in patients with Tau protein-related diseases and normal controls, so as to provide support for the design of clinical trials using imaging biomarkers in the future.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cross-sectional validation study | – | –Each tracer's study will enroll 5 normal controls and 5 cases for each relevant disease, which means [18F]APN-1607 imaging with arterial line will be performed in 5 normal controls, 15 patients with Alzheimer's disease patients, progressive supranuclear palsy (PSP) and frontotemporal dementia (FTD), and [18F] MNI-1126 imaging with Aline test will be performed in 5 normal controls, 15 patients with Alzheimer's disease, progressive supranuclear palsy (PSP) and frontotemporal dementia (FTD); a total of 40 patients will be enrolled in this study group. Patients may choose to participate in the cross-sectional validation study for both tracers, or only for one of them. |
| Longitudinal study | – | –A total of 115 patients are planned to be enrolled in the study. Among them, AD group will enroll 10 cognitive normal controls, 15 prodromal Alzheimer's disease patients and 15 mild Alzheimer's disease patients. Non-AD group will enroll 15 patients with progressive supranuclear palsy (PSP) , 15 patients with frontotemporal dementia (FTD) carrying MAPT gene, 15 patients with FTD without MAPT gene (carrying other FTD related genes such as C9Orf, Progranulin, CHCHD10 or svPPA with TDP43 gene), 15 non-symptomatic carriers with MAPT mutation and 15 normal controls. Subjects who participated in cross-sectional validation study could also participate in this longitudinal study. Patients may also choose to participate only in the longitudinal study. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be separated into two groups: AD group and Non-AD group. Among them, AD group will include cognitive normal controls, prodromal Alzheimer's disease patients and mild Alzheimer's disease patients. Non-AD group will include patients with progressive supranuclear palsy (PSP) , patients with frontotemporal dementia (FTD) carrying MAPT gene, patients with FTD without MAPT gene (carrying other FTD related genes such as C9Orf, Progranulin, CHCHD10 or svPPA with TDP43 gene), non-symptomatic carriers with MAPT mutation and normal controls.
Key inclusion criteria (4 listed)
- Males and females aged 40 to 80 years.
- Females have no fertility due to surgery or at least one year after menopause. Otherwise, pregnancy tests should be conducted during screening and every scan visit and should be negative. Males with fertility must use two methods of contraception during the study period and one of them should be barrier contraception. No sperm donation is allowed during the study period and within 90 days after the completion of this study.
- The subject and the subject's legally authorized representative or caregiver should be willing and able to cooperate during the whole research process. According to the judgement of the researcher, there can be a research companion who has regular and sufficient contact with the subjects (spend more than 10 hours a week together). The companion can provide accurate information about the cognitive and functional aspects of the subject, and agrees to accompany the subjects and provide relevant information during the visits. Research companions must be confirmed by researchers that they have sufficient cognitive ability to accurately report subjects' behavior, cognition and function, and can accompany throughout the whole research process with subjects.
- Researchers believe that the subject can complete all the relevant contents of this study.
Key exclusion criteria (15 listed)
- Current or prior history of any alcohol or drug abuse within the past 3 years (self report).
- Laboratory tests or ECG with clinically significant abnormalities and/or clinically significant unstable medical illness.
- Radiation exposure received from clinical care prior participation in the last year, combined with that from the present study, exceeds an effective dose of 50 mSV.
- Pregnant, lactating or breastfeeding or intention to become pregnant.
- Evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological, immunodeficiency (including a positive HIV result), pulmonary, or other disorder or disease. Stable, treated chronic medical conditions like hypertension, hypercholesterolemia, diabetes mellitus, non-metastatic dermatologic or prostatic cancer, etc. are acceptable as long as they do not, in the investigator's opinion, contribute to cognitive dysfunction or limit participation in study procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The difference of Tau protein deposition and SV2a protein between patients with Tau protein-related diseases and healthy controls
Time frame: March 2020 to December 2022.
through the distribution characteristics, time activity curves and kinetic parameters of the tracers in different populations, and to find out the key imaging parameters related to clinical symptoms.
To evaluate the longitudinal changes of Tau deposition and SV2a in patients with Tau-related diseases and healthy volunteers
Time frame: March 2020 to December 2022.
Changes in each SUVR value or Tau and SV2a distribution were observed in subjects and healthy controls with different diseases
To evaluate the correlation between the longitudinal changes of the deposition of Tau and SV2a
Time frame: March 2020 to December 2022.
clinical symptoms, MRI and serum biomarkers in patients with Tau-related diseases and healthy volunteers.
AE events
Time frame: March 2020 to December 2022.
AE events after the subject scan were determined to evaluate the safety of [18F]APN-1607 and [18F]MNI-1126.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Biao Chen, M.D., Ph.D principal investigator
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Progressive Supranuclear Palsy, run by Xuanwu Hospital, Beijing 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 4 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 2 Mar 2022. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaohui Sun, Nurse (13466660933, xsun@xingimaging.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference of Tau protein deposition and SV2a protein between patients with Tau protein-related diseases and healthy controls (time frame: March 2020 to December 2022.). The study lists 4 primary outcomes in all. 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 2 Mar 2022.