A Bridging Study on Efficacy and Safety of [18F]Florbetaben PET for Diagnosis of Alzheimer Disease Subjects in Chinese Population

NCT05527288 | Completed

• 1 other identifier: YZGK-XT001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Keywords

Florbetaben; Amyloid beta-protein; Alzheimer disease

Outcome Measures

Primary Outcomes (2)

• Verify the safety of subjects after a single intravenous administration of 18FBB in Chinese population.

  Safety will be evaluated by collection of Adverse Events.

  Up to 4 weeks

• 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.

  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.

  Up to 4 weeks

Secondary Outcomes (4)

• 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

• Measurement of the Maximum Plasma Concentration (Cmax) of healthy subjects after single intravenous administration of 18FBB in Chinese population.

  Up to 4 weeks

• Measurement of the Peak Plasma Time (Tmax) of healthy subjects after single intravenous administration of 18FBB in Chinese population.

  Up to 4 weeks

• 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

Study Arms (1)

Non-cognitively impaired subjects or mild to moderate Alzheimer disease subjects

EXPERIMENTAL

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.

Drug: Drug: [18F]florbetaben

Interventions

Drug: [18F]florbetaben DRUG

All eligible patients will receive a single administration of the imaging agent \[18F\]florbetaben at a radioactive dose of 300 MBq.

Non-cognitively impaired subjects or mild to moderate Alzheimer disease subjects

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged between 55 and 85 years old (including 55 and 85 years old);
• 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);
• Be able to understand the purpose and experimental protocol of clinical research;
• 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;
• Clinical dementia score (CDR) of 0, and the Mini-Mental State Examination Scale (MMSE score) of ≥28;
• 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;
• Able to sign the informed consent form.
• Male or female aged between 55 and 85 years old (including 55 and 85 years old);
• The education level of primary school or above, and the ability to complete the cognitive ability test and other tests stipulated in the program;
• Diagnosed as probable AD according to NINCDS-ADRDA criteria;
• ≤MMSE score≤26;
• CDR score of 0.5, 1 or 2;
• The investigator judges that the subject's "caregiver" can provide accurate information and report on the patient's cognitive and functional abilities;
• 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;
• Able to sign the informed consent form.

You may not qualify if:

• History of various mental illnesses such as anxiety disorders, affective disorders, and schizophrenia;
• Depression Screening Scale (PHQ-9) of ≥ 5 points;
• Anxiety Disorder Screening Scale (GAD-7) of ≥ 5 points;
• Severe neurological diseases, such as cerebrovascular diseases, inflammatory or infectious diseases, or any metabolic encephalopathy, neurodegenerative diseases, including Parkinson's disease history or physical or imaging manifestations;
• History of severe craniocerebral injury, craniocerebral surgery or intracranial hematoma with permanent brain injury;
• The results of cranial magnetic resonance imaging (MRI) also meet the following imaging findings: ①There are two or more infarcts outside the brain stem (diameter greater than 2 cm); ②Key parts such as thalamus, hippocampus, entorhinal cortex and angular gyrus Lacunar infarction; ③Fazekas score of high white matter damage ≥3;
• Brain MRI examination showed enlarged perivascular space with subcortical diameter \>3mm in short axis;
• SWI (susceptibility-weighted imaging) prompts: cerebral microbleeds ≥5 locations;
• History of alcohol or drug abuse/dependence;
• Contraindications of MRI examination: such as heart pacemaker or nerve stimulator or metal foreign body, high fever, etc.;
• Invasive surgery is planned within one week after administration of the study drug;
• Allergy to the investigational drug or any of its components and/or a history of severe allergic reaction to the drug or allergens (such as allergic asthma);
• Any major disease or unstable disease state (such as unstable angina pectoris, myocardial infarction or coronary revascularization, heart failure, acute and chronic renal failure, chronic liver disease, severe lung disease, blood disease, poor blood sugar control, chronic infection in the past 2 years, received surgical treatment 7 days ago, advanced cardiac insufficiency (New York Heart Association (NYHA stage IV), etc.);
• History of tumor within 5 years (except cervical carcinoma in situ, prostate carcinoma in situ or local skin cancer after surgery);
• Human immunodeficiency virus (HIV), hepatitis C or Treponema pallidum antibody test positive, hepatitis B surface antigen positive (except hepatitis B carriers);

Sponsors & Collaborators

• Sinotau Pharmaceutical Group: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100039, China

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Plaque, Amyloid

Interventions

4-(N-methylamino)-4'-(2-(2-(2-fluoroethoxy)ethoxy)ethoxy)stilbene

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All eligible patients will receive a single administration of the imaging agent \[18F\]florbetaben at a radioactive dose of 300 MBq.

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: September 2, 2022
• Study Start: January 28, 2021
• Primary Completion: September 12, 2021
• Study Completion: September 12, 2021
• Last Updated: September 2, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)