Effect of a 15-day Memantine Treatment on Biomarkers of AD in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Pharmacog battery
研究概览
简要总结
The early assessment of new drugs for Alzheimer's disease remains difficult because of the lack of predictive end-point. The use of a battery including different parameters could improve this early development of new drugs. Nevertheless, the interest of such a battery should previously be validated with the yet marketed AD drugs.
详细描述
The aim of the present study is to test the effect of a 15-day treatment with memantine on a mixed battery associating cognitive assessment, imaging and neurophysiological tests in healthy volunteers.
This multicenter, randomized, placebo-controlled, cross-over study is double-blind controlled and is conducted in 3 centers located in France (Lille, Marseille and Toulouse).
18-30 years old, healthy volunteers, without any neurological or psychiatric impairment, will complete 2 test sessions in a randomized order: one with a 15-day treatment with memantine, the other with placebo, and will be submitted to a mixed battery during the 14th and 15th day of the treatment. The primary outcome of the study will be based on cognitive assessment, imaging parameters and neurophysiological parameters
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •18-30 year old male non-smoker subjects
- •Subject without cognitive impairment or cognitive complaint (Moca>26, Mac Nair scale<15)
- •Subject without history of brain disease (severe brain trauma, stroke, cerebral tumor,…)
- •Subject without major medical or surgical history
- •Subject without current chronic disease
- •Subject without current cerebral disease
- •Subject without vascular or metabolic risk factor
- •Subject without history or current mental disease or addiction (MINI)
- •Subject without lesion on MRI
- •Subject without abnormal electrical activities on EEG
- •Subject without use of chronic treatment or psychotropic drugs or substances
- •French speaker subject and able to understand the test instructions
排除标准
- •Subject with dementia or cognitive decline identified by Moca < 26
- •Subject with vascular or metabolic risk factor
- •Subject with history or current mental disease or addiction
- •Subject with family history of young-onset dementia
- •Subject with family history of chronic or severe neurological or mental disease (first degree relatives)
- •Subject receiving a chronic treatment
- •Subject with claustrophobia or contra-indication to MRI
- •Subject unable to understand the test instructions
研究组 & 干预措施
Memantine
Memantine will be administered OS as of 10 mg- capsule one per day in the morning over 15 days.
干预措施: Memantine (Drug)
Placebo
The placebo will be presented as capsule comparable to memantine
干预措施: Placebo (Drug)
结局指标
主要结局
Pharmacog battery
时间窗: 15 days
* cognitive tests (8 items of the Cantab battery) : * Motor screening * 4 tests for visual memory (Delayed Matching to Sample, Paired Associated Learning, Pattern Recognition Memory, Spatial Recognition Memory) * 1 test for executive functions (Spatial Working Memory) * 2 tests for attention (Reaction Time, Rapid Visual Information Processing) * completed by a modified ADNI battery : ADAScog * imaging * fMRI * PET-FDG * neurophysiological * EEG
次要结局
未报告次要终点