Functional Neuroimaging Effects of the N-methyl-D-aspartate Receptor (NMDAR) Partial Agonist, GLYX-13, on Learning and Memory in Healthy Individuals
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Percentage of Change in fMRI BOLD Signal During a Category Learning Task
研究概览
简要总结
The present study proposes to evaluate the potential cognitive enhancing effects of GLYX-13, an NMDAR partial agonist, among a group of healthy adults and those with psychiatric illness on a series of functional magnetic resonance imaging (fMRI) learning and memory tasks.
详细描述
In a single blind randomized parallel group design, we will evaluate the whether a single dose of GLYX-13 vs. placebo increases cognitive performance on tasks of learning, declarative memory, and working memory, and associated task-related increases in blood oxygen level-dependent (BOLD) activation in hippocampus and dorsolateral prefrontal cortex, respectively. Positive findings will provide biomarker evidence for GLYX-13 effects on neural systems underlying these cognitive processes.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For all Individuals
- •Male and female subjects
- •Ages 18 - 40 years
- •General intellectual abilities falling broadly within the average range (estimated intelligence quotient (IQ) between 80 - 119)
- •Sufficient ability to understand study requirements and provide written informed consent
- •For Patients
- •Diagnosis of Schizophrenia or Schizoaffective Disorder
排除标准
- •For all individuals:
- •History of neurologic disorder or systemic medical condition that may interfere with central nervous system function
- •History of seizures
- •History of heard injury with loss of consciousness or concussion
- •Positive screen for drugs of abuse: cocaine, marijuana, phencyclidine, ketamine, opioid, or other agent that is being abused in the opinion of the investigator
- •Females who are currently pregnant or plan to become pregnant during the study period
- •History of allergy, sensitivity, or intolerance to N-methyl-D-Aspartate receptor (NMDAR) ligands including ketamine, dextromethorphan, memantine, methadone, dextropropoxyphene, or ketobemidone
- •History of any ferromagnetic object in the body
- •Presence of any medical device or implant for which MRI is contraindicated including cardiac pacemaker, aneurysm clip, cochlear implant, copper intrauterine device (IUD), neurostimulator, or any other device deemed unsafe
- •Bullet or shrapnel in body
- •Metallic braces or permanent retainer
- •Significant claustrophobia
- •For Healthy Individuals
- •Personal history of any Axis I disorder according to the Structured Clinical Interview for the DSM-5 (SCID-5) criteria
- •History of treatment with antidepressant, antipsychotic, stimulant,sedative/ hypnotic, mood stabilizing, or anticholinergic medications or lithium
- •History among first-degree family members of any psychotic illness or major mood disorder (e.g., major depressive disorder, recurrent; bipolar I or II disorder)
- •For Patients
- •Treatment with Clozaril
- •Change in medication within 1 month
- •Hospitalization within 1 month
研究组 & 干预措施
GLYX-13
Single IV infusion of GLYX-13, 5mg/kg,
干预措施: GLYX-13 (Drug)
Placebo
Single IV administration of placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Change in fMRI BOLD Signal During a Category Learning Task
时间窗: within 1 hour of administration
Evidence of enhanced functional magnetic resonance imaging (fMRI) blood oxygen level-dependent (BOLD) signal change during a category learning task among individuals receiving GLYX-13 administration compared to those receiving placebo. Value represents fMRI BOLD signal change (in % change) across a task derived functional network. Higher scores indicate greater task-based activation across this functional circuit.
次要结局
- Category Learning Behavioral Performance(within 1 hour of administration)
研究者
James Reilly
Assistant Professor
Northwestern University