Predictive Value of Biomarkers of the Alzheimer's Disease (AD) in Elderly Patients With New-onset Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 5
- 主要终点
- The primary endpoint was the number of patients in a population of subjects older than 60 years with new-onset epilepsy but without cognitive impairment whose profile of the CSF biomarkers of the AD is suggestive of an AD.
研究概览
简要总结
Beyond 60 years, the prevalence of epilepsy is estimated at approximately 1% and increases with age. In these patients, the etiology of epilepsy is unknown in 25% of cases, even up to 55% after 65 years. Although new-onset epilepsy in the elderly is associated with a vascular disease in 50% of cases, the hypothesis of an ongoing neurodegenerative process, including an Alzheimer's disease (AD), is also common. However, investigators do not have any marker that might help to identify the patients who develop epilepsy after 60 years and who might be, despite a normal cognitive functioning, already engaged in the pathophysiological process of AD.
A number of data suggest a link between the pathophysiological process of AD and epileptogenesis:
(i) a third of patients with epilepsy develops MA, (ii) the occurrence of epilepsy in AD is an aggravating factor for cognition, (iii) in animal models of AD, the relationship between neuronal hyperexcitability and amyloid deposits is bidirectional, the amyloid protein has a pro-seizure effect and the presence of epilepsy increases the amyloid deposits, (iv) in these models, the administration of an antiepileptic drug protects from deterioration of cognition, (v) the close relationship between amyloid and neuronal hyperexcitability might be mediated by the inflammatory processes associated with AD, and particularly the microglial activation which role in epileptogenesis has been shown elsewhere.
Investigators hypothesize that in a subgroup of patients who develop epilepsy after 60 years, the occurrence of epilepsy might reflect the presence of an ongoing amyloid pathology. Our goal is to identify through biomarkers of AD in the cerebrospinal fluid of patients who develop an epilepsy after 60 years with normal MRI and normal cognition those at high risk of later developing clinically defined AD.
Identifying patients with amyloid pathology which would be expressed through epilepsy before the onset of cognitive dysfunction might help to adapt both the management of seizures and of the cognitive dysfunction.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 60 years
- •Patients with newly diagnosed epilepsy according to the latest criteria of the International League against Epilepsy.
- •MMSE ≥ 28/
- •Patients with or without cognitive complaints.
- •Patients whose brain MRI did not reveal significant abnormalities outside slight cortical atrophy.
- •Patients in whom the lumbar puncture did not revealed abnormalities suggestive of an infectious disease or a limbic encephalitis.
- •Patient with adequate visual and auditory skills, an oral and written language in French available to clinical and neuropsychological assessment.
- •Patient who have given its written consent.
排除标准
- •Previous history of epilepsy before age 60 years.
- •Patient with against-indication to MRI (pacemaker, ferromagnetic clips, mechanical heart valves, intra-cochlear implants, intraocular foreign body, skin or other) or refusing MRI.
- •Presence of an abnormality in brain MRI.
- •Patients with diagnostic criteria for dementia of Alzheimer's disease, vascular dementia, mixed dementia or frontotemporal lobar degeneration.
- •Patients with autoimmune encephalitis.
- •Patients under legal protection measure
结局指标
主要结局
The primary endpoint was the number of patients in a population of subjects older than 60 years with new-onset epilepsy but without cognitive impairment whose profile of the CSF biomarkers of the AD is suggestive of an AD.
时间窗: 2 years
次要结局
- Evolution of TOP 10 score(2 years)
- changes in visual recognition memory at 2 years(2 years)
- Evolution of DO 80 score(2 years)
- Evolution of categorical influences(2 years)
- Changes in monthly frequency of seizures at 2 years(2 years)
- changes in episodic verbal memory at 2 years(2 years)