NCT01812213终止2 期
Beta-Amyloid Imaging With [18F]NAV4694 Positron Emission Tomography (PET) in Predicting Progression to Alzheimer's Disease (AD) in Subjects With Mild Cognitive Impairment (MCI)
Navidea Biopharmaceuticals11 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2013年3月最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 76
- 试验地点
- 11
- 主要终点
- Incidence of Mild Cognitive Impairment Progression to Alzheimer's Disease
研究概览
简要总结
To investigate whether [18F]NAV4694 positron emission tomography (PET) scan findings have the ability to distinguish subjects with mild cognitive impairment (MCI) who progress to Alzheimer's disease (AD) from those who do not.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has signed informed consent to participate in the study and continues to give willing consent for participation
- •Age ≥ 55 years with a diagnosis of MCI
- •Educational level of at least 6 years
- •Female subjects will not be of child-bearing potential (> 1 year post-menopausal or surgically sterile)
- •Availability of a "study partner" who can assist in completing rating scales for the duration of the study
- •Cognitive complaints reported by the subject and confirmed by the "study partner"
- •Clinical Dementia Rating (CDR) global score = 0.5
- •Mini-mental state examination (MMSE) score of 24-30
- •Diagnostic and Statistical Manual of Mental Disorders, Version 4, Text Revised (DSM-IV-TR) criteria of dementia not fulfilled
排除标准
- •Has been previously enrolled in this study and received the investigational product
- •Has received an investigational product within 30 days prior to screening
- •Has received disease-modifying therapy that could have changed amyloid brain deposition
- •Has exceeded yearly radioactive dose of 30 mSv
- •Has a known allergy to the study drug or any of its constituents
- •Has a history of alcohol abuse or alcohol dependency in the 3 years prior to study entry, or is an alcoholic or drug addict, as determined by the investigator
- •Has ongoing clinically significant (as judged by the investigator), metabolic or any other disease that could currently cause impaired memory (e.g., untreated thyroid disease, vitamin or other nutritional deficiencies, chronic kidney, or liver disease)
- •Memory impairment that can be attributed to a disease or condition other than an early phase neurodegenerative syndrome
- •Has a parkinsonian movement disorder
- •Use of psychoactive medications that would affect the subject's ability to reliably perform neurocognitive testing or create uncertainty in distinguishing between the effects of the psychoactive medication and the subject's underlying cognitive impairment (e.g., benzodiazepines, sedatives, antipsychotics)
- •Has received any contrast material (X-ray, MRI) or radiopharmaceutical within 48 hours prior to, or a therapeutic radiopharmaceutical (e.g., 131I) within 10 days prior to, or any radiopharmaceutical administration within 10 radioactive half-lives prior to the administration of the investigational product or for whom administration of such substances is planned within 7 days after investigational product administration
- •History of major recurrent depressive disorder (per DSM-IV-TR) within the last 5 years prior to screening
- •Has a brain tumor or other intracranial lesion, a disturbance of cerebral spinal fluid circulation (e.g., normal pressure hydrocephalus), and/or a significant history of head trauma or brain surgery
- •Has signs of major cerebrovascular disease, as verified by medical history and/or brain MRI
- •Is scheduled for surgery and/or another invasive procedure within the 7 days following investigational product administration
- •Has any contraindication to MRI examination, e.g., metal implants, phobia, or cannot undergo an MRI for other reasons such as the inability to lie flat
研究组 & 干预措施
[18F]NAV4694
Experimental
Intravenous [18F]NAV4694 (8.1 mCi) administered once every 18 months
干预措施: [18F]NAV4694 (Drug)
结局指标
主要结局
Incidence of Mild Cognitive Impairment Progression to Alzheimer's Disease
时间窗: 3 Years
Incidence of Mild Cognitive Impairment Progression to Alzheimer's Disease
次要结局
- Incidence of [18F]NAV4694 PET Positive Scans at 18 Months Compared to Baseline(18 months)
- Change in Neuro-cognitive Test Battery Scores at 6 Months Compared to Baseline(6 months)
- Change in Neuro-cognitive Test Battery Scores at 30 Months Compared to Baseline(30 months)
- Change in Neuro-cognitive Test Battery Scores at 36 Months Compared to Baseline(36 months)
- Change in SUVR Scores at 18 Months Compared to Baseline(36 months)
- Incidence of Adverse Events Post Baseline(3 Years)
- Change in Neuro-cognitive Test Battery Scores at 12 Months Compared to Baseline(12 months)
- Change in Neuro-cognitive Test Battery Scores at 18 Months Compared to Baseline(18 months)
- Change in Neuro-cognitive Test Battery Scores at 24 Months Compared to Baseline(24 months)
研究者
研究点 (11)
Loading locations...
相似试验
已完成
1 期
Florbetaben (BAY94-9172) PET (Positron Emission Tomography) Imaging in MCI (Mild Cognitive Impairment) PatientsAlzheimer DiseaseAmyloid Beta-ProteinNCT01138111Life Molecular Imaging SA45
招募中
不适用
Beta Amyloid PET/CT in Various Aβ-Related DiseaseAmyloidBeta-AmyloidNeurodegenerative DiseasesNCT06725706Tianjin Medical University500
已完成
不适用
Amyloid positron emission tomography (PET) imaging in the timely diagnosis of Alzheimer's diseaseAlzheimer's diseaseMental and Behavioural DisordersDementia in Alzheimer diseaseISRCTN17685148Sussex Partnership NHS Foundation Trust10
Unknown
2 期
Amyloid-beta PET Imaging With 18F-92 in Alzheimer's DiseaseAlzheimer's DiseaseNCT04926272First Affiliated Hospital of Fujian Medical University50
已完成
不适用
Amyloid imaging study using positron emission tomography with [F-18]FACT for dementiaDementiaJPRN-UMIN000001420ational Institute of Radiological Sciences60