Neuroinflammation and Cognitive Decline in Alzheimer Disease (AD) : Pilot Study of Translocator Proteins Ligand PET Imaging With [18F]DPA-714
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 6
- 主要终点
- Compare the neuroinflammation measured by fixing and layout of [18F]DPA-714 between 3 groups of patients : subjects suffering from Alzheimer disease light to mild stage, amnesiac MCI and patients suffering from isolated cognitive complaint
研究概览
简要总结
The purpose of this study is to assess the level of neuroinflammation in Alzheimer Disease subject (mild to moderate) estimated with Binding Potential (BP) of [18F]DPA-714, and its relationship with the kinetics of cognitive decline over a 24-month follow-up period (as assessed by Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) and Mini-Mental State Examination (MMSE) scores).
详细描述
The purpose of this study is to assess the level of neuroinflammation in Alzheimer Disease subject (mild to moderate) estimated with Binding Potential (BP) of [18F]DPA-714 , and its relationship with the kinetics of cognitive decline over a 24-month follow-up period (as assessed by ADAS-Cog and MMSE scores).
(DPA-714 : N,N-diethyl-2-[4-(2-fluoroethoxy)phenyl]-5,7-dimethylpyrazolo[1,5-a]pyrimidine-3-acetamide)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Age more than 50 years (included)
- •necessary knowledge of French (write and oral) to do neuropsychological tests
- •Study level upper (or equal) than 7 years (considering first year of grammar-school as start)
- •People with Alzheimer Disease defined as National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) and the Alzheimer's Disease and Related Disorders Association (ADRDA) standards : Light to mild AD defined by Mini-Mental State Examination (MMSE) score between 15 and 25 (included)
- •Social security affiliation.
排除标准
- •MMSE score lower than 15 and upper or equal to 26
- •Evolutive disease which could possibly had consequences on central nervous system
- •Inflammatory disease or evolutive neoplasia and/or C reactive protein (CRP) upper than 10mg/L
- •Chronic use of alchohol and/or drug
- •Serious depression defined by Montgomery Asberg Depression Rating Scale (MADRS) score higher than 18
- •Surgical or medical condition in the last 3 months
- •Long term treatment which could possibly interfere with inflammatory process (especially the month before PET [18F]DPA-714 imaging).
- •Treatment by N-Methyl-D-Aspartate antagonist
- •Treatment by Minocycline
- •Treatment by benzodiazepine (especially the month before PET [18F]DPA-714 imaging) (Zolpidem, zopiclone and loprazolam excepted)
- •Anomaly at neurological examination which is not a classical symptom
- •Contraindication to magnetic resonance imaging (RMI)
- •Florbetapir[18F] hypersensibility
- •Participation to an other experimental protocol with drug.
- •people under guardianship
结局指标
主要结局
Compare the neuroinflammation measured by fixing and layout of [18F]DPA-714 between 3 groups of patients : subjects suffering from Alzheimer disease light to mild stage, amnesiac MCI and patients suffering from isolated cognitive complaint
时间窗: inclusion and 24 months
次要结局
- Relationship passessment between [18F]DPA-714 fixing(Inclusion and 34 months)