- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05326009
A Direct Comparative Study of Tau Tracer in Patients With Alzheimer's Disease (HTH)
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Xiaohui Sun, Nurse
- Phone Number: 13466660933
- Email: xsun@xingimaging.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100053
- Recruiting
- Xuanwu Hospital
-
Contact:
- Biao Chen, MD
- Phone Number: 13501086287
- Email: pbchan@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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,
- 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.
Exclusion Criteria:
- 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.
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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,
|
August 2021 to May 2023
|
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
|
August 2021 to May 2023
|
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
|
August 2021 to May 2023
|
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
|
August 2021 to May 2023
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Biao Chen, Doctor, Xuanwu Hospital, Beijing
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 104
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alzheimer Disease
-
ProgenaBiomeRecruitingAlzheimer Disease | Alzheimer Disease, Early Onset | Alzheimer Disease, Late Onset | Alzheimer Disease 1 | Alzheimer Disease 2 | Alzheimer Disease 3 | Alzheimer Disease 4 | Alzheimer Disease 7 | Alzheimer Disease 17 | Alzheimer Disease 5 | Alzheimer Disease 6 | Alzheimer Disease 8 | Alzheimer Disease 10 | Alzheimer... and other conditionsUnited States
-
Cognito Therapeutics, Inc.RecruitingCognitive Impairment | Dementia | Alzheimer Disease | Mild Cognitive Impairment | Cognitive Decline | Alzheimer Disease, Early Onset | Alzheimer Disease, Late Onset | MCI | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Cognitive Impairment, Mild | Alzheimer Disease 1 | Dementia, Mild | Alzheimer... and other conditionsUnited States
-
AphiosNot yet recruitingDementia | Alzheimer Disease 1 | Alzheimer Disease 2 | Alzheimer Disease 3
-
University of PennsylvaniaNational Institute on Aging (NIA)CompletedDementia | Alzheimer Disease, At Risk | Alzheimer Disease, Protection AgainstUnited States
-
Capital Medical UniversityPeking University First Hospital; The First Affiliated Hospital of Anhui Medical... and other collaboratorsRecruitingAlzheimer Disease | Familial Alzheimer Disease (FAD)China
-
National Taiwan Normal UniversityCompletedAlzheimer Disease 2 Due to Apoe4 IsoformTaiwan
-
Kyoto UniversityOsaka University; Mie University; Tokushima University; Tokyo Metropolitan Geriatric... and other collaboratorsCompletedFamilial Alzheimer Disease (FAD) | PSEN1 MutationJapan
-
University of ArizonaNational Institute on Aging (NIA); University of Southern California; Syneos... and other collaboratorsRecruitingNeurodegenerative Diseases | Alzheimer Dementia | Late Onset Alzheimer DiseaseUnited States
-
Northwell HealthRecruitingAlzheimer Disease | Alzheimer Disease With Delusions | Alzheimer Disease With PsychosisUnited States
-
University of Kansas Medical CenterNational Institute on Aging (NIA)CompletedHealthy Aging | Alzheimer Disease 2 Due to Apoe4 IsoformUnited States