A Phase 0, Open Label, Non-randomized, Multi-center, Exploratory and Safety Study of [F-18]W372
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Safety will be the outcome demonstrated in this clinical trial through analyses of adverse events in subjects who receive study drug.
研究概览
简要总结
PHASE: Phase 0, Exploratory Study
OBJECTIVES: To collect drug safety, bio-distribution and dosimetry data, to begin collection of PET/CT imaging data, to acquire experience to improve study design and the conduct of future studies.
DESIGN: Exploratory, open label, non-randomized, multi-center study.
DURATION: Three visits - one screening, one imaging, and one follow-up visit at 24 hours post-dose
PROCEDURES: Informed consent, collection of demographic information and medical history, administration of mental status exam, physical examination, vital signs, 12-lead ECGs, routine blood tests to assess major organ functions, complete blood counts and clinical chemistries for safety, dosing with [F-18]W372, PET imaging scans of brain (in sixteen subjects), whole body PET imaging and urine collections for dosimetry evaluation (in four subjects only), observation and interviews following imaging to collect adverse events.
SUBJECTS: Twenty (20) subjects ≥ 55 years old:
Group 1 will consist of 10 subjects who have a low probability of being currently positive for Alzheimer's Disease (AD) as defined by the protocol criteria (MMSE ≥ 28). Four of the 10 subjects will undergo whole body PET imaging for dosimetry evaluations, and 6 of the 10 subjects will undergo PET imaging of the brain only.
Group 2 will consist of 10 subjects who have a high probability of currently being positive for AD as defined by the protocol criteria (MMSE < 24); these 10 subjects will undergo PET imaging of the brain only.
详细描述
[F-18]W372 is being developed as a diagnostic radiopharmaceutical for PET imaging of the human brain.
SMI is seeking to determine if [F-18]W372 might be useful as a noninvasive assessment tool in aid of clinical evaluations of subjects with conditions associated with increased amyloid-β deposits, such as Alzheimer's disease.
Compared to the other non-invasive imaging approach, the values of amyloid PET imaging are more sensitive and accurate than previously established measures by FDG PET or volumetric MRI for diagnostic classification of subjects, suggesting that amyloid PET ligands may be more useful in differentiating among Alzheimer's disease, mild cognitive impairment, and normal aging as well as other neurodegenerative diseases. Therefore, this novel kind of molecular markers may provide advantages to measure amyloid plaques in vivo, have the potential to revolutionize early diagnosis of Alzheimer's disease, and hopefully will facilitate the AD diagnosis with improved accuracy.
In this exploratory study, the novel PET ligand for imaging amyloid plaques will be evaluated in age-matched normals with low probability being AD and subjects with high probability being AD in order to determine the bio-distribution, visualize signal/background in brains, and ultimately evaluate the safety and feasibility of [F-18] W372 as a potential PET biomarker for imaging amyloids in human brains.
The IP presents no known risks from either in vitro study in cell lines or in vivo study in animals according to preclinical investigations of this compound.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Low Probability Subjects for AD:
- •Subject has reached his or her 55th birthday at the time of the investigational product administration, and is male or female of any race / ethnicity
- •Subject or subject's legally acceptable representative provides written informed consent
- •Subject is capable of communicating with study personnel
- •For inclusion into Group 1, in the opinion of the Investigator, the subject has a low probability of being currently positive for AD that is determined by a Mini Mental State Examination (MMSE ≥ 28)
- •High Probability Subjects for AD:
- •Subject has reached his or her 55th birthday at the time of the investigational product administration, and is male or female of any race / ethnicity
- •Subject or subject's legally acceptable representative provides written informed consent
- •Subject is capable of communicating with study personnel
- •For inclusion into Group 2, in the opinion of the Investigator, the subject has a high probability of being currently positive for AD that is determined by a Mini Mental State Examination (MMSE < 24)
排除标准
- •For All Subjects:
- •Subject is not capable of complying with study procedures
- •Female subject is pregnant
- •Exclude non-post menopausal females as defined by being one year without menses, or cannot be pregnant from her past medical history
- •Subject has prior history of stroke or other condition of the head or neck that, in the Investigator's opinion, might affect circulation to the head or image interpretation
- •Subject has a medical condition associated with elevated amyloid levels, such as amyloid angiopathy, familial amyloidosis, chronic kidney dialysis, Down's syndrome
- •Subject has a history of significant cerebrovascular disease
- •Subject has a significant hepatic or renal disease as defined by previous medical history or abnormal hepatic and renal functions determined by lab results not within the following ranges, or, in the opinion of the Investigator, the values are not acceptable for the subject to be included:
- •Total bilirubin within 2x institutional upper limits of normal
- •AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limits of normal
- •Serum creatinine ≤ 2x institutional upper limits of normal
- •BUN within 2x institutional upper limits of normal
- •Subject has previously received [F-18]W372 at any time
- •Subject has been involved in an investigative, radioactive research procedure within the past 14 days
- •Subject has any other condition or personal circumstance that, in the judgment of the Investigator, might interfere with the collection of complete data or data quality
- •Subject has a history in the last five years of significant prescription or nonprescription drug or alcohol abuse, including but not limited to marijuana, cocaine, heroin or derivatives.
研究组 & 干预措施
[F-18]W372
Approximately twenty (20) adult subjects including ten (10) healthy volunteers and ten (10) high probability AD subjects, as defined by protocol criteria
干预措施: [F-18]W372 (Drug)
结局指标
主要结局
Safety will be the outcome demonstrated in this clinical trial through analyses of adverse events in subjects who receive study drug.
时间窗: Three (3) study visits, including the initial screening visit, the imaging visit, and the 24 hour follow-up visit
次要结局
未报告次要终点