A Multi-site Double-blind Placebo-controlled Trial of Memantine Versus Placebo in Children With Autism Targeting Memory and Motor Planning
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Developmental Neuropsychological Assessment (NEPSY) Apraxia and Repetition of Nonsense Words Subtests
研究概览
简要总结
This study will attempt to study the effect of memantine, on memory, and motor praxis/expressive language skills in children with autism.
The investigators will recruit children ages 6-12 years who are verbal and meet criteria for Autism Spectrum Disorder. The children will be assessed for memory function, expressive language output and motor skills/praxis. They will then be randomized to memantine or placebo for 6 months. The effects of this medication and its safety in this population will be studied over the 6 month period.
详细描述
Abnormalities in the modulation of the glutamate system have been reported by multiple investigators studying animal models, post-mortem brains, and single gene disorders that have overlapping phenotypes with autism. Abnormalities in glutamatergic function have been reported in disorders affecting a variety of behavioral and neurological domains, from mood stability, to cognitive flexibility, memory, and motor function. Numerous studies have reported a variety of memory and motor deficits in children with autism. Whereas the neurobiology of such deficits is an area of active research, there is a paucity of intervention research for such deficits in autism. This study will attempt to study the effect of an N-methyl-D-aspartate receptor (NMDA) inhibitor, memantine, on memory, and motor praxis/expressive language skills in children with autism.
Methods: Children ages 6-12 years who are verbal and meet criteria for Autism Spectrum Disorder will be recruited across 2 sites. After consent, the children will be assessed for memory function, expressive language output and motor skills/praxis. They will then be randomized 1:1 to memantine versus placebo for 6 months. The effects of this medication on the above mentioned symptoms domains as well as its safety in this population will be studied over the 6 month period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Patients born prior to 35 weeks gestational age
- •Patients with any primary psychiatric diagnosis other than autism at Screening: a history of Attention Deficit Hyperactivity Disorder (ADHD), bipolar disorder, psychosis, post-traumatic stress disorder, schizophrenia, or major depressive disorder
- •Patients with a medical history of neurological disease, including, but not limited to, epilepsy/seizure disorder (except simple febrile seizures), movement disorder, tuberous sclerosis, fragile X, and any other known genetic syndromes, or known abnormal MRI/structural lesion of the brain
- •Patients with a medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being. Patients with evidence or history of malignancy or any significant hematological, endocrine, cardiovascular (including any rhythm disorder), respiratory, renal, hepatic, or gastrointestinal disease.
- •Patients who plan to initiate or change pharmacological or nonpharmacologic interventions during the course of the study
- •Patients on d-cycloserine or riluzole as they both target the glutamate system
- •Patients on agents that alkalinize the urine (acetazolamide, potassium citrate, and sodium bicarbonate), as they decrease the elimination of memantine
- •Patients who have received treatment with memantine in the past with no response
- •Patients with a history of hypersensitivity reaction to dextromethorphan, amantadine, or any other NMDA receptor antagonists
- •Patients unable to tolerate venipuncture procedures for blood sampling
- •Patients who, in the Investigator's opinion, might not be suitable for the study
- •Children weighing under 20 kg (to meet FDA approvals)
- •Patients with a positive pregnancy test
研究组 & 干预措施
Memantine
干预措施: Memantine (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Developmental Neuropsychological Assessment (NEPSY) Apraxia and Repetition of Nonsense Words Subtests
时间窗: Baseline, Week 12, Week 24 (Measuring change from Baseline, middle of trial and end of trial)
Outcome Measure is going to report a change. The NEPSY provides a developmental neuropsychological assessment for children age 3-12. It was designed to assess basic and complex aspects of cognitive capacities that are critical to children's ability to learn and be productive both in and out of school settings
Expressive Vocabulary Test (EVT)
时间窗: Baseline, Week 12, Week 24 (Measuring change from Baseline, middle of trial and end of trial)
次要结局
- Vineland Adaptive Behavior Scale - Revised(Baseline, Week 12, Week 24 (Measuring change from Baseline, middle of trial and end of trial))
- Safety Monitoring Uniform Research Form(Screening, Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12, Week 16, Week 20, Week 24)
研究者
Evdokia Anagnostou
Clinician Scientist
Anagnostou, Evdokia, M.D.