Depression in the Elderly and Cerebral Amyloid Plaques: Characterization by [18F] AV-45 Affectives Symptoms and Amyloïd Plaques (ASAP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 10
- 主要终点
- standards uptakes values (SUVr)
研究概览
简要总结
The primary objective of the study is to compare the brain amyloid load in fully, partially and non remitting depressed elderly patients at 8 weeks of antidepressant therapy, by using PET with [F18]AV45.
详细描述
The main aim of this study is to assess the brain amyloid load in treated depressed elderly subjects using PET with [F18]AV45. The investigators hypothesize that the brain amyloid load will be higher in non or partially remitting depressed subjects treated with antidepressants than in fully remitting ones. An additional two years follow-up will allow comparing the brain amyloid load at baseline between those who will have evolved towards MCI or MA and those who will not, including ApoE genotype, the cognitive performances at baseline, the hippocampus volume as assessed by MRI, the type and profile of mood disorder (number of past episodes, age at first episode, vascular risk factor profile, response profile to antidepressants), as covariates.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult 55 years or older
- •Native language : french
- •Study period > 7 years
- •Major depression defined on the DSM-IV criteria assessed by MINI and HDRS score of 10 or over
- •Affiliation to the national health insurance system
- •Signed informed consent
排除标准
- •History of alcoholism or drug addiction
- •MMSE less than or equal to 17
- •Major depression with psychotic features
- •Depressive episode resistant, patient who received two different antidepressants well conducted without significant therapeutic response
- •Any current or past episode of mania, schizophrenia or any other psychotic disorder
- •Any past history of stroke or Parkinson's disease
- •Any current significant unstable illness
- •Any past diagnosis of Alzheimer's disease
- •Any current treatment by AcethylCholinesterae inhibitor, memantine or antidepressant therapy.
- •Contraindications to MRI in patients with:
- •Metallic foreign body eye.
- •Any implanted electronic medical irremovably (pacemaker, neurostimulator, cochlear implants ...)
- •Metal heart valve,
- •Vascular clips formerly located on cranial aneurysm.
- •Contraindications to antidepressants
- •History of progressive disease that can affect the central nervous system such as uncontrolled diabetes, blood pressure greater than or equal to 180/100; chronic lung disease with hypoxia, head trauma with loss of consciousness greater than or equal to 15 minutes; brain surgery, encephalitis, recently treated cancer (<1 year), altered cerebral metabolism including subjects with stroke sequelae extended. Patients with lacunar stroke without thalamic or striatal may be included.
研究组 & 干预措施
18FAV45
干预措施: 18FAV45 (Drug)
结局指标
主要结局
standards uptakes values (SUVr)
时间窗: 2 months
次要结局
- Residual cognitive deficits(2 years)