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An fMRI and EEG study in patients with mild to moderate Alzheimer*s disease and healthy elderly controls - fMRI and EEG study in Alzheimer patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Aged 50- 80 years;
- •2. Ability to communicate well with the investigator in the Dutch language;
- •3. Willing to give written informed consent and to comply with the study
- •restrictions;
- •Additional inclusion criteria for the AD subjects are:
- •4. Diagnosed with probable AD according to the National Institute of
- •Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease
- •and Related Disorders Association (NINCDS-ADRDA) criteria confirmed by the
- •treating physician;
- •5. MMSE score 18-26 (inclusive);
- •6. CDR global rating score of 0.5 or 1.0 or 2 at screening;
- •Additional inclusion criteria for the healthy controls are:
- •7. MMSE score * 27.
排除标准
- •1. Any contra-indications for MRI (prostheses, implants, claustrophobia,
- •pacemakers, etc.);
- •2. Presence or history of alcohol abuse, or daily alcohol consumption exceeding
- •2 standard drinks per day on average for females or exceeding 3 standard drinks
- •per day on average for males (1 standard drink = 10 grams of alcohol), or a
- •positive breath alcohol test at screening or upon admission to the Clinical
- •Research Unit (CRU);
- •3. Use of tobacco and/or nicotine-containing products within 30 days of day 1;
- •4. Positive urine drug screen at screening or day 1;
- •5. Unable to refrain from use of (methyl) xanthine (e.g. coffee, tea, cola,
- •chocolate) from 24 hours prior to day 1 until discharge from the CRU;
- •6. Use of concomitant medication which reduces the level of alertness;
- •7. Concussion or other acute head trauma in the past six months.
- •8. A Geriatric Depression Scale * 15 (GDS) score *6;
- •Exclusion criteria for AD subjects are:
- •9. Clinically relevant history of abnormal physical or mental health, other
- •than AD, interfering with the study as determined by medical history taking
- •obtained during the screening visit and/or at the start of day 1 as judged by
- •the investigator (including (but not limited to), neurological, psychiatric,
- •endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal
- •10. Use of cholinesterase inhibitors, Memantine or herbal treatments such as
- •Ginkgo Biloba in patients with mild AD.
- •Exclusion criteria for healthy subjects:
- •11. Clinically relevant history of abnormal physical or mental health
- •interfering with the study as determined by medical history taking and physical
- •examinations obtained during the screening visit and/or at the start of day 1
- •as judged by the investigator (including (but not limited to), neurological,
- •psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic,
- •or renal disorder).
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