Alzheimer DiseaseHTHNCT05326009
A Direct Comparative Study of Tau Tracer in Patients With Alzheimer's Disease
An observational study of Alzheimer Disease, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
In this study, a total of 60 AD patients with Aβ deposition will beenrolled.Qualified subjects will complete PET imaging scan of Tau imaging agent inXuanwuHospital, and each subject will receive three of the following five imaging agents: PI-2620, APN1607, AV1451, RO948 or GTP1.The imaging time interval between the… Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Alzheimer Disease
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2021to 31 May 2023
- 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 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In this study, a total of 60 AD patients with Aβ deposition will be enrolled.
Who may be able to join
- Age 55-80, male or female.
- The legal authorizer or caregiver of the subject (if applicable) needs to sign the informed consent before any assessment.
- Based on the NINCDS / ADRDA and DSM-IV standards, it is likely to have AD dementia, with mild severe amnesia.
- Screening CDR score = 0.5, and MMSE score is between 24-26 (AD patients in prodromal stage).
- Or,
- CDR score = 0.5 or 1, and MMSE score is between 20-23 (mild AD patients) -Or,
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- CDR score = 2, and MMSE score is between 15-21 (for moderate AD patients).
- It has received PET imaging examination of amyloid protein or [18F] florbetapir imaging examination within 12 months before screening, and it is confirmed that there is amyloid binding based on qualitative analysis (visual read) and quantitative analysis. The results of amyloid PET imaging will be shared with participants, and the scanning results may be used by participants for future research.
- There is no obvious evidence of other neuropathology in brain MRI supporting AD diagnosis.
- Before the screening visit date, patients taking symptomatic treatment drugs must maintain a stable maintenance dose for at least 30 days.
- Female subjects must have medical records or doctor's records for surgical infertility (through hysterectomy, bilateral ovariectomy or tubal ligation) or at least 1 year after menopause, otherwise, pregnancy test is required in screening period and every scanning visit and should be negative. Male subjects and their fertile partners must promise to use two methods of contraception during the study period, and one of them is barrier contraception for male subjects.
- Male subjects are not allowed to donate sperm during the study and within 90 days after the completion of the study.
- Willing and able to cooperate with the research process.
- A qualified subject's Research Companion needs regular and sufficient contact between the research companion and the subject (weekly time ≥ 10 hours), can provide accurate information about the subject's cognition and function, and agrees to accompany the subject and provide relevant information during the visit. The study companion must have sufficient cognitive ability to accurately report the behavior, cognition and function of the subjects. The same study companion should be able to accompany the subjects to participate in the whole study process.
Who cannot join
- Any existing or 3-year history of alcohol or drug abuse (self statement)
- Laboratory examination or ECG indicates significant clinical abnormalities and / or important unstable clinical diseases.
- In the past year, the amount of radiation received by participating or clinical clinics in combination with this research institute has exceeded 50mSV (the annual limit allowed by FDA for research volunteers).
- Serious gastrointestinal, cardiovascular, liver and kidney, blood, tumor, endocrine, potential nervous system, immune deficiency (including HIV positive), pneumonia and other diseases. Stable, treated chronic disease conditions such as high blood pressure, hyperlipidemia, diabetes, non metastatic skin cancer or prostate cancer, which researchers believe will not cause cognitive impairment or restrict participation in the study, are acceptable.
- In addition to AD, the history or current status of neurological diseases that may affect cognition, including but not limited to Parkinson's disease, cortical basal ganglia degeneration, dementia of Lewy body, CJD, Huntington's disease, normal intracranial pressure hydrocephalus, tic disease, hypoxia, or other serious CNS trauma with significant clinical significance.
- Other diseases or causes may cause the subjects to fail to complete the whole study.
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- MRI exclusion criteria include: evidence that may affect cognition, such as significant evidence of cerebrovascular disease (more than two lacunar infarcts, any infarct larger than 1cm3, or deep white matter abnormality, equivalent to Fazekas score level 3, at least one fusion high signal lesion on FLAIR sequence, i.e. ≥20mm in any dimension), infectious diseases, space occupying lesions, normal pressure hydrocephalus, central nervous system injury or any other structural abnormality that may affect cognition.
- Internal implants such as cardiac pacemaker or defibrillator, insulin pump, cochlear implant, metal eye foreign body, implanted nerve stimulator, central nervous system aneurysm clip and other medical implants that can not receive MRI, or MRI examination has a history of claustrophobia.
- Daily use of anticholinergic antidepressants, typical antipsychotics or barbiturates. Infrequent use of typical antipsychotics for vomiting or barbiturates for migraine treatment is permitted, provided that no dose is taken during the 5 half lives prior to screening or any neurocognitive assessment.
- Daily use of benzodiazepines, opioids or opioids. However, intermittent short-term treatment is permitted, except for use in the 5 half-lives prior to screening or any neurocognitive assessment.
- Use hypnotics, stimulants, atypical antipsychotics, central anticholinergic antihistamines, or anticholinergic antispasmodics with central effect, unless (a) they are administered daily, so that they will not start or stop treatment or dose change within the first five half lives of screening or at any time during the study period, or (b) they are administered intermittently and in a short period, while in screening or neurocognition Not used in the first 5 half lives of the assessment.
- In the 12 months before screening, use any therapeutic molecule or treatment method targeting Aβ, or use the treatment targeting tau in the 24 months before screening
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital
Beijing, Beijing Municipality, 100053
Biao Chen, MD, 13501086287, pbchan@hotmail.com
About this study
In this study, a total of 60 AD patients with Aβ deposition will beenrolled.Qualified subjects will complete PET imaging scan of Tau imaging agent inXuanwuHospital, and each subject will receive three of the following five imaging agents: PI-2620, APN1607, AV1451, RO948 or GTP1.The imaging time interval between the two tracers should be at least 4 days but less than 4 weeks. All PET scans of each subject were completed within 3 months.To compare the different Tau tracers' binding ability (SUVR or Tau distribution change) of the same subject in AD population. Obtain the safety data of each tracer after injection.
Read the detailed description
Patients with AD in prodromal stage, mild or moderate degree, who have stable medical condition and meet the inclusion criteria, do not meet any exclusion criteria, will be eligible for inclusion in this study.
[18F] florbetapir PET imaging will be used to evaluate amyloid deposition during the screening period. If [18F] florbetapir imaging confirmed amyloid deposition based on positive visual reading and SUVR > 1.1, the patient was considered to be amyloid deposition positive.After the subjects enter the group, the comprehensive collection of clinical information, the assessment of cognitive related scale and the collection and detection of biological samples are carried out. Qualified subjects will complete PET imaging scan of Tau imaging agent in Xuanwu Hospital, and each subject will receive three of the following five imaging agents: PI-2620, APN1607, AV1451, RO948 or GTP1. All subjects will sign the tracer related informed consent before PET tracer injection. Imaging will be carried out as detailed in the technical operation manual. PET center staff will closely observe and evaluate adverse events of subjects throughout the process, and allow them to leave the hospital after confirming medical stability. After 48 hours of scanning, the staff will follow up the subjects by telephone to confirm the health status of the subjects and record the information related to adverse events. The imaging time interval between the two tracers should be at least 4 days but less than 4 weeks. All PET scans of each subject were completed within 3 months.
- Conditions
- Alzheimer Disease
- Keywords
- Alzheier Disease, PET imaging, AV45, AV1451, Tau
- Medical subject headings
- Alzheimer Disease, Pick Disease of the Brain
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the different Tau tracers' binding ability of the same subject in AD population.
SUVR value was used to compare AD population different Tau targeting tracers, evaluate the tau binding capacity of different Tau tracers in AD population,
Measured: August 2021 to May 2023
Assessing the potential value of tracers in AD diagnosis
Comparison of specific regions bound to specific tau tracers in the same subject AD population at each visit
Measured: August 2021 to May 2023
To compare the different Tau tracers' binding ability of the same subject in AD
Tau distribution changewas used to compare AD population different Tau targeting tracers, evaluate the tau binding capacity of different Tau tracers in AD population
Measured: August 2021 to May 2023
Obtain the safety data of each tracer after injection.
Number of adverse events recorded from baseline to follow-up by CTCAE v4.0
Measured: August 2021 to May 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start20 Nov 2021
- Primary completion31 Jan 2023 (estimated)
- Study completion31 May 2023 (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
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- H. Lundbeck A/S, Hoffmann-La Roche, Genentech, Inc., Life Molecular Imaging SA., APRINOIA Therapeutics, XingImaging, LLC, Hangzhou G-Bio Biotechnology Co., Ltd
- Responsible party
- Principal investigator, Piu Chan, Xuanwu Hospital, Beijing
- Investigators
- Biao Chen, Doctor, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05326009
- Sponsor's protocol ID
- 104
- Acronym
- HTH
- Status last verified
- Apr 2022
- First submitted
- 17 Feb 2022
- Last updated
- 13 Apr 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 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Direct Comparative Study of Tau Tracer in Patients With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT05326009
- Acronym / sponsor ID
- HTH / 104
- Conditions
- Alzheimer Disease
- Keywords
- Alzheier Disease, PET imaging, AV45, AV1451, Tau
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- H. Lundbeck A/S, Hoffmann-La Roche, Genentech, Inc., Life Molecular Imaging SA., APRINOIA Therapeutics, XingImaging, LLC, Hangzhou G-Bio Biotechnology Co., Ltd
- Study start
- 20 Nov 2021 (actual)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 13 Apr 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.
In this study, a total of 60 AD patients with Aβ deposition will beenrolled.Qualified subjects will complete PET imaging scan of Tau imaging agent inXuanwuHospital, and each subject will receive three of the following five imaging agents: PI-2620, APN1607, AV1451, RO948 or GTP1.The imaging time interval between the two tracers should be at least 4 days but less than 4 weeks. All PET scans of each subject were completed within 3 months.To compare the different Tau tracers' binding ability (SUVR or Tau distribution change) of the same subject in AD population. Obtain the safety data of each tracer after injection.
Detailed description
Patients with AD in prodromal stage, mild or moderate degree, who have stable medical condition and meet the inclusion criteria, do not meet any exclusion criteria, will be eligible for inclusion in this study.
[18F] florbetapir PET imaging will be used to evaluate amyloid deposition during the screening period. If [18F] florbetapir imaging confirmed amyloid deposition based on positive visual reading and SUVR > 1.1, the patient was considered to be amyloid deposition positive.After the subjects enter the group, the comprehensive collection of clinical information, the assessment of cognitive related scale and the collection and detection of biological samples are carried out. Qualified subjects will complete PET imaging scan of Tau imaging agent in Xuanwu Hospital, and each subject will receive three of the following five imaging agents: PI-2620, APN1607, AV1451, RO948 or GTP1. All subjects will sign the tracer related informed consent before PET tracer injection. Imaging will be carried out as detailed in the technical operation manual. PET center staff will closely observe and evaluate adverse events of subjects throughout the process, and allow them to leave the hospital after confirming medical stability. After 48 hours of scanning, the staff will follow up the subjects by telephone to confirm the health status of the subjects and record the information related to adverse events. The imaging time interval between the two tracers should be at least 4 days but less than 4 weeks. All PET scans of each subject were completed within 3 months.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In this study, a total of 60 AD patients with Aβ deposition will be enrolled.
Key inclusion criteria (14 listed)
- Age 55-80, male or female.
- The legal authorizer or caregiver of the subject (if applicable) needs to sign the informed consent before any assessment.
- Based on the NINCDS / ADRDA and DSM-IV standards, it is likely to have AD dementia, with mild severe amnesia.
- Screening CDR score = 0.5, and MMSE score is between 24-26 (AD patients in prodromal stage).
- Or,
Key exclusion criteria (12 listed)
- Any existing or 3-year history of alcohol or drug abuse (self statement)
- Laboratory examination or ECG indicates significant clinical abnormalities and / or important unstable clinical diseases.
- In the past year, the amount of radiation received by participating or clinical clinics in combination with this research institute has exceeded 50mSV (the annual limit allowed by FDA for research volunteers).
- Serious gastrointestinal, cardiovascular, liver and kidney, blood, tumor, endocrine, potential nervous system, immune deficiency (including HIV positive), pneumonia and other diseases. Stable, treated chronic disease conditions such as high blood pressure, hyperlipidemia, diabetes, non metastatic skin cancer or prostate cancer, which researchers believe will not cause cognitive impairment or restrict participation in the study, are acceptable.
- In addition to AD, the history or current status of neurological diseases that may affect cognition, including but not limited to Parkinson's disease, cortical basal ganglia degeneration, dementia of Lewy body, CJD, Huntington's disease, normal intracranial pressure hydrocephalus, tic disease, hypoxia, or other serious CNS trauma with significant clinical significance.
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
To compare the different Tau tracers' binding ability of the same subject in AD population.
Time frame: August 2021 to May 2023
SUVR value was used to compare AD population different Tau targeting tracers, evaluate the tau binding capacity of different Tau tracers in AD population,
Assessing the potential value of tracers in AD diagnosis
Time frame: August 2021 to May 2023
Comparison of specific regions bound to specific tau tracers in the same subject AD population at each visit
To compare the different Tau tracers' binding ability of the same subject in AD
Time frame: August 2021 to May 2023
Tau distribution changewas used to compare AD population different Tau targeting tracers, evaluate the tau binding capacity of different Tau tracers in AD population
Obtain the safety data of each tracer after injection.
Time frame: August 2021 to May 2023
Number of adverse events recorded from baseline to follow-up by CTCAE v4.0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 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, Doctor 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, 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 14 inclusion and 12 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 13 Apr 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?
To compare the different Tau tracers' binding ability of the same subject in AD population. (time frame: August 2021 to May 2023). 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 13 Apr 2022.