Alzheimer Disease, Brain Diseases, Central Nervous System Diseases, Dementia, Mental Disorders, Nervous System Diseases, Neurocognitive Disorders, Neurodegenerative Diseases, Tauopathies
Conditions
Keywords
Florbetaben, Amyloid beta-protein, Alzheimer disease
Brief summary
This is a bridging study to visually and quantitatively assess PET images obtained after single application of 300 MBq \[18F\]florbetaben and PET scanning of patients with Alzheimer disease.
Detailed description
This is a bridging study to visually and quantitatively assess PET images obtained after single application of 300 MBq \[18F\]florbetaben and PET scanning of patients with healthy subjects and non-cognitively impaired subjects or mild to moderate Alzheimer disease subjects. The diagnostic efficacy of the visual and quantitative assessments of 18FBB PET images for diagnosis of Alzheimer disease will be determined by comparison to the standard of truth (SoT) obtained through standard of care clinical diagnosis. Imaging results were compared with reference standards to assess the ability of 18FBB PET imaging to differentiate non-cognitively impaired subjects from mild to moderate AD subjects. To investigate the pharmacokinetic characteristics of healthy subjects after single intravenous administration of 18FBB in Chinese population. Verify the safety of subjects after a single intravenous administration of 18FBB in Chinese population.
Interventions
DRUGDrug: [18F]florbetaben
All eligible patients will receive a single administration of the imaging agent \[18F\]florbetaben at a radioactive dose of 300 MBq.
Sponsors
Sinotau Pharmaceutical Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
All eligible patients will receive a single administration of the imaging agent \[18F\]florbetaben at a radioactive dose of 300 MBq.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
1\. Inclusion criteria for non-cognitively impaired subjects: 1. Male or female aged between 55 and 85 years old (including 55 and 85 years old); 2. The education level of primary school or above, and can 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); 3. Be able to understand the purpose and experimental protocol of clinical research; 4. 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; 5. Clinical dementia score (CDR) of 0, and the Mini-Mental State Examination Scale (MMSE score) of ≥28; 6. 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; 7. Able to sign the informed consent form. 2\. Inclusion criteria for subjects with mild to moderate AD: 1. Male or female aged between 55 and 85 years old (including 55 and 85 years old); 2. The education level of primary school or above, and the ability to complete the cognitive ability test and other tests stipulated in the program; 3. Diagnosed as probable AD according to NINCDS-ADRDA criteria; 4. 18≤MMSE score≤26; 5. CDR score of 0.5, 1 or 2; 6. The investigator judges that the subject's caregiver can provide accurate information and report on the patient's cognitive and functional abilities; 7. 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; 8. Able to sign the informed consent form. 3\. Inclusion criteria for healthy subjects: 1. Male or female aged 18 to 40 years old (including 18 years old and 40 years old); 2. Good health or no major diseases, as judged by the investigator based on the following evaluations: medical history, vital signs, physical examination, electrocardiogram and results of clinical laboratory tests; 3. Not using any drugs; 4. EEG examination, judged as normal; 5. Screening blood routine, blood biochemistry and urine routine are normal, or the abnormality has no clinical significance; 6. Women must use effective contraceptive measures during the study period and within 6 months after the end of the study (effective contraceptive measures refer to sterilization, intrauterine hormone devices, condoms, contraceptives/agents, abstinence or partner removal of the vas deferens, etc.) ; male subjects should agree to use contraception during the study period and within 6 months after the end of the study period; 7. Able to sign the informed consent form.
Exclusion criteria
1\.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Verify the safety of subjects after a single intravenous administration of 18FBB in Chinese population. | Up to 4 weeks | Safety will be evaluated by collection of Adverse Events. |
| Evaluation of the ability of qualitative readings of PET imaging to distinguish non-cognitively impaired subjects from mild to moderate AD subjects after a single intravenous administration of 18FBB in Chinese population. | Up to 4 weeks | Sensitivity and specificity of18FBB PET images for diagnosis of Alzheimer disease will be measured by comparison to the standard of truth (SoT) obtained through standard of care clinical diagnosis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the ability of quantitative analysis of PET imaging to distinguish non-cognitively impaired subjects from mild to moderate AD subjects after a single intravenous administration of 18FBB in Chinese population. | Up to 4 weeks | Sensitivity and specificity of 18FBB PET images for diagnosis of Alzheimer disease will be measured by comparison to the standard of truth (SoT) obtained through standard of care clinical diagnosis. |
| Measurement of the Maximum Plasma Concentration (Cmax) of healthy subjects after single intravenous administration of 18FBB in Chinese population. | Up to 4 weeks | Pharmacokinetic characteristics is described by Cmax. |
| Measurement of the Peak Plasma Time (Tmax) of healthy subjects after single intravenous administration of 18FBB in Chinese population. | Up to 4 weeks | Pharmacokinetic characteristics is described by Tmax. |
| Measurement of Area Under the Curve （AUC）for plasma concentration of healthy subjects after single intravenous administration of 18FBB in Chinese population. | Up to 4 weeks | Pharmacokinetic characteristics is described by AUC. |
Countries
China
Outcome results
None listed