Double-Blind, Placebo-Controlled Study of ALTO-101 in Patients With Schizophrenia and Cognitive Impairment
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 82
- 试验地点
- 14
- 主要终点
- Theta band activity
研究概览
简要总结
This is a Phase 2, double-blind, placebo-controlled, two-way crossover study to compare the efficacy of ALTO-101T versus placebo in change in electroencephalogram (EEG) cognitive processing markers and measures of cognition.
Additional goals are to assess pharmacokinetic (PK), safety, and tolerability of the recently developed ALTO-101T transdermal delivery system (TDS) formulation in a patient population.
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
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Schizophrenia diagnosis for at least one year
- •Cognitive impairment
- •Stable doses of 1-2 antipsychotic medication(s) for at least 8 weeks at Visit 2
- •Positive and Negative Syndrome Scale (PANSS) score: items P1, P3-P6 ≤ 5 and item P2 and P7 ≤ 4 during screening
- •Have a body mass index (BMI) ≥ 18.0 and ≤ 37.0 kg/m2 (inclusive)
- •Willing to comply with all study assessments and procedures
排除标准
- •Evidence of unstable medical condition
- •Acute psychiatric decompensation or severity of symptoms requiring psychiatric hospitalization in past 6 months
- •Diagnosis of schizoaffective or bipolar affective disorder, dementia, or intellectual disability
- •Current episode of major depressive disorder (MDD)
- •Use of mood stabilizer, clozapine, and/or daily benzodiazepine
- •Current moderate or severe substance use disorder
研究组 & 干预措施
ALTO-101
10 days administration of ALTO-101T transdermal delivery system
干预措施: ALTO-101 (Drug)
ALTO-101
10 days administration of ALTO-101T transdermal delivery system
干预措施: ALTO-101 Transdermal Delivery System (Device)
Placebo
10 days administration of placebo transdermal delivery system
干预措施: Placebo (Drug)
Placebo
10 days administration of placebo transdermal delivery system
干预措施: Placebo Transdermal Delivery System (Device)
结局指标
主要结局
Theta band activity
时间窗: Treatment Period 1 - Day 6 and Day 11; Treatment Period 2 - Day 6 and Day 11
Theta band activity after 5 and 10 days of dosing of ALTO-101T compared to placebo.
次要结局
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] ALTO-101T compared to placebo(Treatment Period Day 1 through study completion (an average of 36 days))