Double Blind, Two Dose, Cross-over Clinical Trial of the Positive Allosteric Modulator at the alpha7 Nicotinic Cholinergic Receptor AVL-3288 in Schizophrenia Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Score
研究概览
简要总结
Single-center, outpatient, randomized, double-blind, placebo-controlled, 3-treatment-phase, cross-over study to evaluate the safety, tolerability and efficacy of two oral doses of AVL-3288 each compared to placebo, in patients with schizophrenia.
详细描述
This study will be in 24 non-smoking outpatients with schizophrenia or schizoaffective disorder. Subjects will complete three treatment phases, each involving 5 straight days of taking AVL-3288 (10 mg or 30 mg study drug or placebo) followed by a 16 day washout period in which subjects do not take the study drug to ensure that the drug is completed eliminated from the body before the next phase.
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
- •DSM-V diagnosis of schizophrenia or schizoaffective disorder
- •RBANS Total Scale Score >62
- •Willing to provide informed consent
- •Medically stable for study participation
- •Taking an antipsychotic medication other than clozapine at a stable dose for at least 4 weeks
- •Judged clinically not to be at significant suicide or violence risk
排除标准
- •Substance abuse (excluding nicotine) within last 90 days
- •ECG abnormality that is clinically significant
- •Current clozapine use
- •Participation in a study of investigational medication/device within 4 weeks
- •Pregnancy, lactation, or lack of use of effective birth control
- •Active tobacco use
- •Presence or positive history of significant medical or neurological illness, including cardiac illness, WBC <3500/mm3, absolute neutrophil count <1500/mm3, ALT or AST values >1.5 times upper limit of normal. Hemoglobin less than 130 g/L (13 g/dL) in males or 120 g/L (12 g/dL) in females or known HIV +
- •Contraindication to MRI scanning, including metal implants or claustrophobia
- •Medicinal patch, unless removed
研究组 & 干预措施
AVL-3288 10 mg
AVL-3288 10 mg daily for 5 days
干预措施: AVL-3288 (Drug)
AVL-3288 30 mg
AVL-3288 30 mg daily for 5 days
干预措施: AVL-3288 (Drug)
Placebo
Placebo daily for 5 days
干预措施: Placebo (Drug)
结局指标
主要结局
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Score
时间窗: End of each 5-day treatment phase
Compare effect of active drug (AVL-3288) to placebo on RBANS total score
次要结局
- Calgary Depression Rating Scale (CDRS) Total score(End of each 5-day treatment phase)
- P50 suppression measured by electroencephalographic (EEG)(End of each 5-day treatment phase)
- Scale for the Assessment of Negative Symptoms (SANS) Total score(End of each 5-day treatment phase)
- Brief Psychiatric Rating Scale (BPRS) Total score(End of each 5-day treatment phase)
- Intensity of hippocampal BOLD fMRI signal during MRI scan(end of each 5-day treatment phase)
- RBANS index T-score subscales(End of each 5-day treatment phase)
研究者
Joshua Kantrowitz
Assistant Professor of Clinical Psychiatry
New York State Psychiatric Institute