DRKS00000780已完成2 期
Memory, Ageing, and the Cholinergic System a combined fMRI and PET study - MACS
niversitätsklinikum Köln0 个研究点目标入组 42 人开始时间: 2011年3月30日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 50 Years 至 80 Years（—）
- 性别
- All
入选标准
- •healthy older subjects (age 50-80 years)
- •patients with mild cognitive impairment (< 2 SD in Verbal learning and memory test, 50-80 years)
- •both groups:
- •informed consent
- •normal neurological examination
- •normal physical examination of the body including auscultation of the lungs and heart as well as abdominal palpation
- •normal ECG
- •Systolic blood pressure 100-160 mmHg
- •Diastolic blood pressure 50-100 mmHg
- •heart frequency 50-100
排除标准
- •instable cardiovascular diseases, neurologic or psychiatric diseases (except for mild cognitive impairment in the MCI group), insable diseases of the lungs, instable gastrointestinal diseases, instable diseases of the kidneys and the urinary tract, thyreotoxicosis, cancer, pregnancy, breast feeding, persons standing in dependency on the sponsor or investigator, placement into an institution due to governmental or judicial order, participation in other interventional studies potentially interfering with the currrent study, existing therapy with acetylcholinesterase inhibitors, missing secure measure to prevent pregnancy
- •additionally for experiments with Rivastigmin:
- •–hypersensitivity to rivastigmin or other carbamate derivetives
- •–Asthma bronchiale
- •–liver insufficiency
- •–renal insufficiency
- •–coronary heart disease
- •–cardiac rhythm disturbances like bradycardia, tachycardia, Sick Sinus Syndrome
- •–gastric or duodenal ulces
- •–mechanic constipation or mechanic urinary retention
- •–intestinal obstruction
- •–concomitant application of cholinesterase inhibitor
- •–application of anticholinergic agents
- •–Hypotension
- •for the fMRI experiments
- •–pacemaker or other implanted stimulation devices
- •–Infusion device / medication pump
- •–metal parts in or at the body
- •–claustrophobia
- •–grinding of metallic objects up to 1 week before fMRI measures
- •healthy subjects:
- •–prior application of radioactive substances or ionising radiation during nuclear medicine investigations, hypersensitivity to MP4A.
- •Patients with mild cognitive impairment:
- •–participation in other nuclear medicine investigations if exceeding limits named in § 88 Abs. 2 Strahlenschutzverordnung
- •–prior application of radioactive substances or ionising radiation during nuclear medicine investigations in a radiation therapy
- •–hypersensitivity to MP4A.
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