Subjects With Subjective Cognitive Decline: 18F-Florbetaben Positron Emission Tomography Study
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 30
- 主要终点
- Positive visual FBB-PET scan
研究概览
简要总结
Phase II, open-label clinical trial with a medicinal product. A total of 30 subjects will be included in the study.
All participants will receive a single intravenous dose of 300 MBq of FBB. A 20-minute PET image should be acquired starting at approximately 90 minutes after intravenous injection of FBB.
The present proposal aims are: to assess safety of a single dose of FBB followed by PET scan in individuals with subjective cognitive decline (SCD), to determine the number of SCD subjects with positive visual FBB-PET scan, to determine the number of SCD subjects with positive standardized uptake value ratios (SUVRs) of FBB-PET scan and to explore the cortical pattern of amyloid deposition in SCD subjects.
详细描述
statistical methods: Primary outcomes For the analysis of the primary outcomes, a descriptive statistical approach will be implemented, calculating the proportion of adverse events and the proportion of SCD subjects that are positive for FBB-PET at visual assessment 9.2 Data Management Demographical and neuropsychological data will be entered in a data base. Statistical analyses will be performed with the SPSS software for Windows (v.22.0).
Sample size A sample size of 30 subjects has been estimated. Since this is a proof-of-concept study, this assumption has been based on previously published data.
Statistical significance and adjustments for multiplicity The analysis will be carried out according to the principles of the ICHE9 Guide and in accordance with the recommendations of CPM/EWP/908/99 Points to Consider on Multiplicity issues in Clinical Trials. The contrast will be carried out with an Error of Type 5 bilateral I. In any case, since this is a exploratory study, there will be no adjustments for multiplicity.
Criteria for discontinuation
The study will be completed when these two premises are met:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be committed to participate and complete all study procedures.
- •The patient must report a memory problem (in isolation or in combination with complaints in other domains) with concern.
- •Mini-Mental State Examination cutoff for inclusion will be ≥
- •Clinical Dementia Rating <0,
- •Subjects must have signed the Informed Consent Form voluntarily to participate in the study.
排除标准
- •Subjects those are not able to complete the study.
- •Any major disease or history of a major disease, especially hepatobilliar disease (AST /ALT ≥ 5 x ULN) or advanced renal insufficiency (creatinine ≥ 2 x ULN).
- •Current or previous history of alcohol abuse or epilepsy.
- •Allergic to Florbetaben or any of its constituents.
- •Multiple drug allergies and/or previous history of contrast allergy.
- •Any disease or history of disease which, in the opinion of the investigator, can cause disturbance of brain function (e.g. vitamin B12 or folic acid deficiency, disturbed thyroid function).
- •Evidence for any other neurological or psychiatric disease, eg. parkinsonism, history of stroke or seizure.
- •Pregnancy or breast feeding or planned pregnancy during the study period.
研究组 & 干预措施
18F-Florbetaben (FBB)
18F-Florbetaben
干预措施: 18F-Florbetaben (FBB) (Drug)
结局指标
主要结局
Positive visual FBB-PET scan
时间窗: 24 months
Proportion of Subjective Cognitive Decline subjects that present positive uptake after FBB-PET through visual examination.
Incidence of Adverse Events
时间窗: 24 months
Incidence of Adverse events of a single dose of FBB followed by PET scan in individuals with Subjective Cognitive Decline
次要结局
- Cortical pattern of amyloid deposition(24 months)
- Positive standardized uptake value ratios(24 months)
研究者
Anna Cruceta
Project Manager
Fundacion Clinic per a la Recerca Biomédica