Longitudinal Study of Brain Amyloid imaGing in MEMENTO
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 448
- 试验地点
- 26
- 主要终点
- Progression to clinical dementia stage according to standardized classifications (DSM-IV and NINCDS-ADRDA) as described in the MEMENTO protocol.
研究概览
简要总结
A Multicenter national longitudinal cohort study including at least 800 individuals consecutively recruited from French Research Memory Centers and followed-up over 24 month and included in Memento.
详细描述
Alzheimer's disease (AD) is the most common cause of dementia in the elderly, affecting approximately 7.3 million people in Europe. AD is a clinicopathologic entity for which the definitive diagnosis requires both the presence of the clinical signs of dementia and pathological evidence of amyloid plaque in the brain (obtained at autopsy).
Currently, diagnosis of AD at early stage of the disease is hampered by the lack of noninvasive and validated biomarkers of the underlying pathology. On one hand, it is suggested that between 10% and 20% of patients currently diagnosed with AD, based on clinical evidence solely, lack AD pathology at autopsy, and on the other hand community physicians may not diagnose AD in 33% of patients with mild signs and symptoms. Thus, there is a need for validated diagnostic biomarker that could help clinicians separate patients who do not have AD from those who have pathological signs and should be referred for further evaluation and care management. Furthermore, little is known on the prognosis value for dementia conversion of current biomarkers of AD pathology at a preclinical or presymptomatic stage.
Recently, 18F-labeled positron emission tomography (PET) imaging agents have been developed that bind with high affinity to the amyloid-β (Aβ) peptide fibrils that constitute amyloid plaques, and thus, have potential value as an imaging biomarkers for amyloid deposits in subjects with cognitive impairment or isolated cognitive complaints.
The principal objective of this ancillary study is to investigate the prospective association between PET amyloid load, measured twice two years apart, through either Florbetapir (18F) or Flutemetamol (18F) radioligands, and dementia incidence over up to 5 years of follow-up in a sample of individuals presenting with a spectrum of cognitive profiles ranging from isolated cognitive complaints to cognitive deficits without dementia.
The secondary objectives are the following:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be included in MEMENTO
- •To have signed a specific MEMENTO-AmyGing informed consent form, prior to any amyloid PET procedures
- •To have had or agreed to have 18F-FDG PET scan in MEMENTO
- •To tolerate the (18F) PET scan procedures, in the opinion of the clinical site investigator
- •Clinical Dementia Rating scale <0.5 and not demented
排除标准
- •To have a current clinically significant psychiatric condition that neurologists/geriatricians feel would preclude the ability to have a research PET scan
- •To be pregnant or breastfeading women
- •To have Hypersensitivity to the tracer or to the excipient listed in the summary of the product carateristics (florbetapir Amyvid®) or the Investigator's Brochure (flutemetamol)
- •To have a relevant history of severe drug allergy or hypersensitivity (relevant severe drug allergies should be determined by the clinical site investigator or co-clinical site investigator). If a subject has a history of severe drug allergies, it may be dangerous for them to participate in a study with a novel compound
- •To have ever participated in an experimental study with an amyloid targeting agent (e.g. anti-amyloid immunotherapy, γ-secretase or γ-secretase inhibitor) unless it can be documented that the subject received only placebo during the course of the trial
- •To receive any investigational medications, or have participated in a trial with investigational medications within the last 30 days
- •To have participated less than 1 year ago in a biomedical research with injection of one of the amyloid radioligand or to be enrolled in an ongoing biomedical research including amyloid PET scan
- •To have had a radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session
研究组 & 干预措施
Flutemetamol (18F)
干预措施: Flutemetamol (18F) (Drug)
Florbetapir (18F)
干预措施: Florbetapir (18F) (Drug)
结局指标
主要结局
Progression to clinical dementia stage according to standardized classifications (DSM-IV and NINCDS-ADRDA) as described in the MEMENTO protocol.
时间窗: 24 months from baseline
次要结局
- Prodromal AD (Pre-symptomatic dementia)(24 months from the baseline)
- Etiology of dementia, when converted(24 months from the baseline)
- Longitudinal evolution of biomarkers measured from blood, CSF, structural neuroimaging (MRI) and glucose metabolism molecular neuroimaging (18F-FDG PET).(24 months from baseline)
- Mortality(24 months from baseline)
- Longitudinal evolution of amyloid load measured through either Florbetapir (18F) or Flutemetamol (18F)(24 months from baseline)
- Loss of autonomy based on functional activity assessment(24 months from baseline)
- Quality of life(24 months from baseline)
- Institutionalization(24 months from baseline)
- Cardiovascular event (Stroke and Coronary events)(24 months from baseline)
- Speed of cognitive decline based on change in cognitive performances(24 months from baseline)