NL-OMON37710已完成不适用
A randomized, double blind, placebo-controlled crossover study to investigate the effects of cholinergic and serotonergic challenges with galantamine and citalopram on resting state FMRI in aging and dementia. - Pharmacological resting state FMRI in aging and dementia.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Part A: Healthy subjects;• Have a body-mass index (BMI) between 18 and 34 kg/m2.
- •All subjects participating in this study are absent on cognitive deficits with a Mini Mental State Examination (MMSE) score between 28 and 30.
- •Each subject is familiar with the procedures of the study, and agrees to participate in the study program by giving oral and written informed consent.
- •Healthy young subjects: age 18-30.
- •Healthy elderly subjects: age 55-75.;Part B-D: Dementia patients
- •A body-mass index (BMI) between 18 and 34 kg/m2.
- •All patients participating in this study only have mild cognitive deficits with a Mini Mental State Examination (MMSE) score between 21 and 27.
- •Patients will be assessed by the treating neurologist as mentally capable of understanding the implications of study participation.
- •Each patient is familiar with the procedures of the study, and agrees to participate in the study program by giving oral and written informed consent. ;Part B: patients with Alzheimer's disease
- •The clinical diagnosis AD will be established according to the revised NINCDS-ADRDA criteria for diagnosing probable AD.
- •Age 55-75.;Part C: patients with frontotemporal lobe dementia
- •The clinical diagnosis possible FTLD will be established according the revised International Consensus Criteria for frontotemporal lobar degeneration, and supported by neuropsychological deficits and frontal and/or temporal atrophy (MRI) or hypoperfusion (ASL, SPECT). All patients will undergo extensive history taking and neurological examination in order to exclude other causes of frontal dysfunction.
- •Age 50-70.;Part D: patients with dementia with Lewy bodies
- •The diagnosis DLB will be made according to clinical criteria for probable DLB.
- •Age 55-75.
排除标准
- •Contra-indication to MRI scanning (pacemaker and defibrillator, intraorbital or intraocular metallic fragments, cochlear implants, one or more metal eartubes, intracranial clips, a non-removable insulin pump, a non-removable neurostimulator, a mechanical cardiac valve, an hydrocephalus pump, ferromagnetic implants, intra-uterine device, permanent make-up, tattoos above the shoulders, pregnancy, operation in 6 weeks preceding the MRI, claustrophobia, inability to lie still for a period of 20 minutes in the MRI scanner, Fear or problems during the RS-FMRI scan).
- •Clinically relevant abnormal history of physical and mental health as determined by medical history taking and physical examinations obtained during the screening visit (as judged by the investigator).
- •Other causes that can explain cognitive symptoms.
- •Clinically relevant abnormal laboratory results, ECG and vital signs, or physical findings at screening (as judged by the investigator).
- •Positive test for hepatitis B, C or HIV.
- •Subjects using, on average, more than 4 units of alcohol per day, and unable to refrain from alcohol use during the study days.
- •Subjects smoking, on average, more than 5 cigarettes per day, and unable to refrain from smoking during the study days.
- •Subject is a habitual and heavy consumer of caffeinated beverages (more than 6 cups of coffee or equivalent/day) at the time of the study and/or is not able to refrain from use of (methyl) xanthines (e.g. coffee, tea, cola, chocolate) during study days.
- •Positive drug or alcohol test at screening and/or study days.
- •History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the study drug.
- •Participation in an investigational drug trial in the 3 months prior to administration of the initial dose of study drug or more than 4 times per year.
- •Donation or loss of blood (> 500 mL) within 3 months prior to screening.
- •Inadequate venous accessibility as judged by the physician or nurse.
- •Use of benzodiazepine within 48 hours before a study day.
- •Use of monoamine oxidase inhibitors (MAOIs) from 14 days prior to the first study day until 7 days after the last study day (incl. linezolid).
- •Severe asthma or obstructive pulmonary disease or active pulmonary infections (e.g. pneumonia).
- •Pregnancy or breast feeding.
- •Any other condition that in the opinion of the investigator would complicate or compromise the study, or the well being of the subject.
- •Use of medication in the 2 weeks prior to the first study day that is, in the opinion of the investigator, interfering with the study or the study medication.
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