NCT02353949终止3 期
Investigating the Clinical Consequences of Flutemetamol-PET-scanning
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Change of ADAS-cog 11 score compared to pre-treatment assessment in Flutemetamol positive subjects with a postscan diagnosis of AD and start of cholinesterase inhibitors as standard treatment.
研究概览
简要总结
The study examines subjects where there might be an indication for Amyloid-PET according to the Criteria defined by the Amyloid Imaging Task Force. In these subjects the impact of a Flutemetamol (Vizamyl)-Positron-Emission-Tomography -Scan (PET) on clinical management and disease course will be studied over 6 months.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dementia expert considers an Amyloid-scan appropriate according to Amyloid-imaging task force criteria (AIT) after conference with an Amyloid-PET expert
- •Preambles of the AIT-Criteria are fulfilled
- •A cognitive complaint with objectively confirmed impairment
- •AD as a possible diagnosis, but when the diagnosis is uncertain after a comprehensive evaluation by a dementia expert
- •When knowledge of the presence or absence of Abeta pathology is expected to increase diagnostic certainty and alter Management
- •Patients with persistent or progressive unexplained MCI
- •Patients satisfying core clinical criteria for possible AD because of unclear clinical presentation, either an atypical clinical course or an etiologically mixed presentation
- •Patients with progressive dementia and atypically early age of onset (65 years or less in age)
- •other situations where preambles of AIT-Criteria are fulfilled
- •Diagnosis was established in a memory clinic or by an experienced physician in dementia diagnostics
- •The diagnostic procedures comprise in minimum MRI, neuropsychology, routine blood test for exclusion of symptomatic causes
- •MMSE >15
- •Competency to consent
- •Trial partner willing to support study physician
- •Written informed consent by both patient and trial partner
- •Understanding of German language
- •Treating physician willing to collaborate with the study team
排除标准
- •Cognitive impairment which can be attributed to another underlying medical condition that renders a possibility of Alzheimer's disease very unlikely (thus violating preamble B)
- •Clinically significant Depression (decided upon clinical assessment)
- •MRI exclusion criteria
- •PET exclusion criteria
- •Allergy to Flutemetamol or any of the excipients of the solution for injections
- •History of severe allergic reactions to drugs or allergens
- •Pregnancy or lactation
研究组 & 干预措施
Flutmetamol Group
Experimental
PET-MR-Scan with 80-140 MBq Flutemetamol before observational period for diagnostic purpose
干预措施: Flutemetamol (Vizamyl) (Drug)
结局指标
主要结局
Change of ADAS-cog 11 score compared to pre-treatment assessment in Flutemetamol positive subjects with a postscan diagnosis of AD and start of cholinesterase inhibitors as standard treatment.
时间窗: Three months after initiation of standard treatment
次要结局
- Change of ADCS-ADL score compared to pre-treatment assessment in Flutemetamol positive subjects with a postscan diagnosis of AD and start of cholinesterase inhibitors as standard treatment.(Three months after initiation of standard treatment)
- Change of ADCS-CGIC score compared to pre-treatment assessment in Flutemetamol positive subjects with a postscan diagnosis of AD and start of cholinesterase inhibitors as standard treatment.(Three months after initiation of standard treatment)
- Change of MMSE score compared to pre-treatment assessment in Flutemetamol positive subjects with a postscan diagnosis of AD and start of cholinesterase inhibitors as standard treatment.(Three months after initiation of standard treatment)
研究者
研究点 (1)
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