Alzheimer Disease
Conditions
Keywords
Tau PET, Dosimetry, Alzheimer's disease, Chinese, XTR006
Brief summary
This is an investigator-initiated clinical (IIT)study.The main purpose of this study was to evaluate the diagnostic efficacy of XTR006 PET qualitative reading and quantitative analysis in detecting mild cognitive impairment（MCI）due to AD and mild to moderate AD based on clinical diagnosis, and to establish XTR006 PET imaging parameters and qualitative reading and quantitative analysis methods.
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. 90 Chinese subjects (30 subjects with non-cognitive impairment, 30 subjects with MCI due to AD and 30 subjects with mild to moderate AD) who meet all of the inclusion and none of the exclusion criteriawill be enrolled in this IIT study. Subjects will receive 8-10mCi of XTR006 via IV injection. qualitative reading and quantitative analysis methods will be investigated. Safety and tolerability will be observed.
Interventions
DRUGXTR006
All participants will receive a single intravenous dose of 8.0-10.0mCi of XTR006 followed by PET scan
Sponsors
Sinotau Pharmaceutical Group
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
30 subjects with non-cognitive impairment, 30 subjects with MCI due to AD， 30 subjects with mild to moderate AD.
Eligibility
Sex/Gender
ALL
Age
55 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* 1\. Inclusion criteria for non-cognitively impaired subjects 1. Male or female aged between 55 to 85 years old (including 50 and 85 years old); 2. Clinical dementia score (CDR) of 0; 3. the Mini-Mental State Examination Scale (MMSE score) of ≥28; 4. Aβ PET imaging is negative; 5. Able to cooperate with the tests required for research including neuropsychological tests (cognitive ability, language ability, visual and auditory acuity can meet the requirements of the test); 6. The researcher judges that the subjects are in good health, and there is no abnormal or abnormality in the comprehensive physical examination, vital sign examination and laboratory examination, but they can participate in this bridging clinical trial according to the judgment of the clinician; 7. For women of potential fertility (not yet or within 2 years of menopause), effective contraceptive measures must be used during the study period and within 6 months after the end of the study (effective contraceptive measures refer to sterilization, intrauterine hormonal devices, contraception condoms, contraceptives/dose, abstinence or partner removal of the vas deferens, etc.); male subjects should agree to use contraceptives during the study period and within 6 months after the end of the study period; 8. Able to sign the informed consent form. * 2\. Inclusion criteria for MCI due to AD 1. Male or female aged between 55-85 years old (including 50 and 85 years old); 2. Diagnosed as MCI due to AD according to NIA-AA standard in 2011; 3. Have symptoms of subjective memory loss and maintain independent ability of daily life; 4. MMSE score≤27; 5. CDR score=0.5; 6. Aβ PET imaging is positive; 7. Able to cooperate with the tests required for research including neuropsychological tests (cognitive ability, language ability, visual and auditory acuity can meet the requirements of the test); 8. For women of potential fertility (not yet or within 2 years of menopause), effective contraceptive measures must be used during the study period and within 6 months after the end of the study (effective contraceptive measures refer to sterilization, intrauterine hormonal devices, contraception condoms, contraceptives/dose, abstinence or partner removal of the vas deferens, etc.); male subjects should agree to use contraceptives during the study period and within 6 months after the end of the study period; 9. Able to sign the informed consent form. * 3\. Inclusion criteria for subjects with mild to moderate AD 1. Male or female aged between 50-85 years old (including 55 and 85 years old); 2. Diagnosed as probable AD according to NIA-AA standard in 2011; 3. MMSE score≤27 4. 1≤CDR score≤2; 5. Aβ PET imaging is positive; 6. Have the ability to complete the cognitive ability test and other tests specified in the protocal; 7. The investigator judges that the subject's caregiver can provide accurate information and report on the patient's cognitive and functional abilities; 8. For women of potential fertility (not yet menopause or within 2 years of menopause), effective contraceptive measures must be used during the study period and within 6 months after the end of the study (effective contraceptive measures refer to sterilization, intrauterine hormonal devices, contraception condoms, contraceptives/dose, abstinence or partner removal of the vas deferens, etc.); male subjects should agree to use contraceptives during the study period and within 6 months after the end of the study period; 9. Able to sign the informed consent form.
Exclusion criteria
* 1\.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To investigate the sensitivity and specificity of XTR006 PET imaging by reading | day 1 | Sensitivity and specificity of XTR006 PET images for diagnosis of MCI and AD will be measured by comparison to the standard of truth (SoT) obtained through standard of care clinical diagnosis. |
| To investigate the sensitivity and specificity of XTR006 PET imaging by SUVR | day 1 | Sensitivity and specificity of XTR006 PET images for diagnosis of MCI and AD will be measured by comparison to the standard of truth (SoT) obtained through standard of care clinical diagnosis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To investigate the consistency among XTR006 PET readers and the reproducibility of the readers themselves. | day 1 | Kappa value between XTR006 PET images readers and Kappa value of readers themselves. |
| To investigate the parameters of XTR006 PET imaging in the brain | 0 to 130 minutes post injection | PET images were collected 0-130min after a single intravenous administration of XTR006, and the start time when the SUVR value of Braak brain region was stable with cerebellar gray matter as the reference area was analyzed |
| Descripte study product-related adverse events by numbers,degree and kinds as assessed by CTCAE v5.0 | up to 7days | Safety Observation: Number of participants with adverse events and severe adverse events after drug injection. |
| To investigate the quantitative analysis methodology of XTR006 PET. | day 1 | SUVR cut off value and Sensitivity/specificity of different XTR006 PET quantitative analysis rules for diagnosis of MCI and AD. |
| To investigate the methodology of XTR006 PET qualitative reading | day 1 | Sensitivity and specificity of different XTR006 PET qualitative reading rules for diagnosis of MCI and AD. |
Countries
China
Outcome results
None listed