NCT01574456已完成不适用
Blood-brain Barrier Permeability in Alzheimer's Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- The main study measures are blood brain barrier permeability as measured by T1-weighted dynamic contrast MRI
研究概览
简要总结
The main aim of the present study is to improve our understanding of the role of blood-brain barrier function in dementia of the Alzheimer's type. The investigators hypothesize that microvascular dysfunction - more specifically "cerebral perfusion and blood-brain barrier leakage" - is a determinant of cognitive decline and cortical atrophy in Alzheimer's disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with AD:
- •Informed consent before participation in the study
- •Received standard diagnostic procedure according to the Parelsnoer Initiative procedure
- •Diagnosed with dementia of the Alzheimer's type
- •Clinical dementia rating (CDR) of 1, which means a mild to moderate stage of dementia
- •MMSE ≥ 20 and patients are mentally competent (in general, individuals with an MMSE ≥ 18 are considered mentally competent)
- •Patients with prodromal AD:
- •Informed consent before participation in the study
- •Received standard diagnostic procedure according to the Parelsnoer Initiative procedure
- •Diagnosis of prodromal dementia according to the Dubois criteria (16)
- •CDR of 0.5, which suggests a very mild stage of dementia
- •Memory impairment defined as Delayed Recall on Verbal Learning Test (15 WLT) < 1.5 SD
- •MMSE ≥ 20 and patients are mentally competent.
- •Medial temporal lobe atrophy scale MTA ≥ 1 (17) OR abnormal levels of Aß42, t-tau or p-tau
- •Healthy participants:
- •Informed consent before participation in the study
- •No Diagnosis of dementia, prodromal dementia, or mild cognitive impairment.
- •MMSE ≥ 26
- •No substantial memory complaints (according to participant)
- •Age, gender and education is matched to the patient groups.
排除标准
- •Contraindications for scanning (e.g. brain surgery, cardiac pacemaker, metal implants, claustrophobia, large body tattoos)
- •Contraindications for contrast agent Gadovist (renal failure) as determined by the estimated Glomular Filtration Rate eGFR < 30 mL/min.
- •Major vascular disorders (e.g. stroke, heart disease)
- •Psychiatric or neurological disorders: Major depression (< 12 months); history of schizophrenia; bipolar disorder; psychotic disorder NOS or treatment for a psychotic disorder (< 12 mnd); cognitive impairment due to alcohol abuse; epilepsy; Parkinson's disease; MS; brain surgery; brain trauma; electroshock therapy; kidney dialysis; Meniere's disease; and brain infections.
- •Structural abnormalities of the brain
- •Cognitive impairment due to alcohol/drug abuse
- •Absence of reliable informant (for patient groups)
结局指标
主要结局
The main study measures are blood brain barrier permeability as measured by T1-weighted dynamic contrast MRI
时间窗: 22 months
次要结局
未报告次要终点
研究者
研究点 (2)
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