Liraglutide Effects on Memory in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change from baseline in performance on a two-dimensional object location task on day 1 and day 35.
研究概览
简要总结
This study examines the hypothesis, that subcutaneous administration of liraglutide, an analogue of the incretin glucagon-like peptide 1, over 5 weeks improves memory functions in healthy humans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age 18-35 years
- •Body mass index between 19 and 25 kg/m2
- •Non-smoker
排除标准
- •Receipt of any drug within 4 weeks prior to this trial
- •Any known acute or chronic disease of the brain, heart, lung, kidney,liver, pancreas or gastrointestinal tract, any metabolic, endocrine or psychiatric disease.
- •Brady- and Tachycardia, i.e. heart rate < 50 and > 90 beats per minute.
- •Hypertension (systolic blood pressure > 150 mmHg, diastolic blood pressure > 90 mmHg).
- •Hyperlipidemia (cholesterol, LDL, triglyceride > two times the upper reference limit based on analysis from the central laboratory)
- •Impaired hepatic function measured as alanine aminotransferase (ALAT) > two times the upper reference limit based on analysis from the central laboratory
- •Impaired renal function measured as creatinine > 120 µmol/l based on analysis from the central laboratory
- •Family history of diabetes
- •History of any eating disorder
- •Known or suspected allergy to trial products
- •History of drug or alcohol abuse within the last five years prior to screening
研究组 & 干预措施
Liraglutide
See "Intervention"
干预措施: liraglutide (Drug)
Placebo
See "Intervention"
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in performance on a two-dimensional object location task on day 1 and day 35.
时间窗: Day -7, Day 1, Day 35
Change from Baseline in the immediate and delayed recall of a declarative memory task (word list recall) at time points indicated in "time frame" section.
时间窗: Day -7 (immediate Recall 1), Day 0 (Delayed Recall 1), Day 1 (Immediate Recall 2), Day 7 (Delayed Recall 2), Day 28 (Immediate Recall 3), Day 35 (Delayed Recall 3)
Change from baseline in the immediate and delayed recall of an Episodic Memory Task (story recall) at the time points indicated in the "Time Frame" - section.
时间窗: Day -7 (immediate Recall 1), Day 0 (Delayed Recall 1), Day 28 (Immediate Recall 2), Day 35 (Delayed Recall 2)
Change from baseline in performance on a working-memory task on day 1 and day 35.
时间窗: Day -7, Day 1, Day 35
Digit Span Test
Change from baseline in immediate and delayed recall of a procedural memory task at the time points indicated in the "Time Frame" - section.
时间窗: Day -7 (immediate Recall 1), Day 0 (Delayed Recall 1), Day 28 (Immediate Recall 2), Day 35 (Delayed Recall 2)
Finger tapping test
次要结局
- Change from baseline in resting metabolic rate on day 7, 28 and 35.(Day 0 , Day 7 , Day 28 , Day 35)
- Change from baseline in serum/plasma concentrations of parameters involved in glucose metabolism on day 1,7,28, and 35.(Day -7, 1, 7, 28, 35)
研究者
Dr. med. Volker Ott
Principal Investigator
University of Luebeck