Phase I Nicotinic Agonist Treatment Trial for Autism
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Difference between drug and placebo on the CPT at 30 minutes after administration
研究概览
简要总结
This study plans to learn more about whether a nicotine-like investigational new drug, DMXB-A [3-(2,4-dimethoxybenzylidene) anabaseine] may have positive effects on mental focus and may help us to find new types of treatment for autism spectrum disorder. Subjects will come in for a screening visit and three more drug visits. There will be at least one week between each drug visit to allow the drug to be eliminated from your system completely. During each drug visit subjects will receive either a placebo (a capsule that looks like medicine but is not real), 75 mg of DMXB-A, or 150 mg of DMXB-A. During the drug day vital signs and well being will be monitored by the study physician. Subjects will complete some paper and pencil tasks to test memory, attention, speed, and problem solving, some rating scales and questionnaires, and the study team will record brain wave patterns with an electroencephalogram (EEG) .
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-50
- •meet DSM-5 criteria for Autism Spectrum Disorder, Levels 1 or 2, as defined by Autism Diagnostic Observation Schedule
- •non-smoking persons
- •in good health
排除标准
- •persons with estimated verbal and nonverbal IQ <
- •abuse of other substances.
- •Persons not sufficiently fluent in English to permit testing
- •those with history of severe head injury
- •Fragile X Syndrome
- •Rett Syndrome
研究组 & 干预措施
DMXB-A 75 mg
DMXB-A 75 mg dose followed by a second dose of 37.5 mg at 2 hours to maintain the blood level
干预措施: DMXB-A 150 mg (Drug)
DMXB-A 75 mg
DMXB-A 75 mg dose followed by a second dose of 37.5 mg at 2 hours to maintain the blood level
干预措施: placebo (Other)
DMXB-A 150 mg
DMXB-A 150 mg followed by a second dose of 75 mg at 2 hours to maintain the blood level
干预措施: placebo (Other)
DMXB-A 150 mg
DMXB-A 150 mg followed by a second dose of 75 mg at 2 hours to maintain the blood level
干预措施: DMXB-A 75 mg (Drug)
Sugar Pill
placebo comparator dose followed by a second placebo dose at 2 hours to maintain blind
干预措施: DMXB-A 150 mg (Drug)
Sugar Pill
placebo comparator dose followed by a second placebo dose at 2 hours to maintain blind
干预措施: DMXB-A 75 mg (Drug)
结局指标
主要结局
Difference between drug and placebo on the CPT at 30 minutes after administration
时间窗: 30 minutes after drug administration
Difference between placebo and drug on the Social Responsiveness scale 2 hours after administration
时间窗: 2 hours after drug administration
Difference between drug and placebo on theTotal Scale Score on the repeatable Battery for the Assessment of neuropsychological Status at 2 hours after administration
时间窗: 2 hours after drug administration
Difference between the P50 auditory evoked potential test/conditioning ratio 1 hour after administration
时间窗: 1 hour after drug administration
次要结局
未报告次要终点