XanaCIDD: a Double-Blind, Randomized, Placebo Controlled, Parallel-Group Trial to Assess the Safety, Tolerability, and Efficacy of Xanamem® in Adults with Major Depressive Disorder and Impaired Cognition
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 167
- 试验地点
- 12
- 主要终点
- Efficacy of Xanamem on attention, including working memory
研究概览
简要总结
Xanamem is being developed as a potential treatment for symptomatic, early stages of Alzheimer's Disease (AD) and Major Depressive Disorder (MDD).
This XanaCIDD Phase II study in MDD is to investigate the safety and efficacy of Xanamem™ in treating patients with cognitive and depressive symptoms. Trial participants will be randomized to either receive 10mg of Xanamem™ once daily or a Placebo at a 1:1 ratio in a double-blinded fashion.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18 to 75, inclusive.
- •Positive MDD primary diagnosis confirmed by the Mini-International Neuropsychiatric Interview (MINI).
- •Persistent depressive symptoms as determined by a Hamilton Depression Rating Scale (HAM-D) ≥ 17 at Screening.
- •Cognitive abilities on a coding test > 0.5 standard deviations below expected.
- •Self-reported subjective cognitive dysfunction.
- •Currently or previously treated with a stable dose of a first- or second-line antidepressant that is approved for the treatment of depression (but not a tricyclic antidepressant, monoamine oxidase inhibitor, or vortioxetine). If on current treatment, dose must be stable for at least 6 weeks.
- •Smokers are eligible if they are able to comfortably abstain from nicotine for 2 hours prior to scheduled cognitive assessments.
- •Able to comfortably abstain from caffeine intake for 4 hours prior to scheduled cognitive assessments.
- •Must provide written informed consent to participate in the trial and be willing and able to comply with the requirements of the protocol and complete all trial visits.
排除标准
- •Active suicidal ideation within the previous 3 months
- •On a tricyclic antidepressant, monoamine oxidase inhibitor, esketamine, or vortioxetine.
- •A history of clinically diagnosed dementia of any type
- •Previous clinically significant systemic illness or infection, including test positive COVID-19, within the past 4 weeks prior to Screening
- •Has a BMI or body weight that will interfere with participation in the trial
- •Type I or Type II diabetes requiring insulin
- •Clinically significant ECG abnormalities
- •Participation in another clinical trial of a drug or device
- •Trial participants who in the opinion of the Investigator exhibit physical, cognitive, or language impairments of such severity as to adversely affect the validity of the data derived from the neuropsychological tests.
- •Positive testing for HIV, hepatitis B surface antigen, or hepatitis C antibodies at Screening.
- •Participants with a history of drug abuse or addiction in the past 2 years
- •Current use of cannabis/marijuana, or tetrahydrocannabinol-containing medications.
研究组 & 干预措施
10 mg Xanamem™
10 mg Xanamem™ capsule, to be administered orally once every morning with or without food
干预措施: Xanamem™ (Drug)
Placebo
Placebo capsule, to be administered orally once every morning with or without food
干预措施: Placebo (Drug)
结局指标
主要结局
Efficacy of Xanamem on attention, including working memory
时间窗: 6 Weeks (Baseline to Week 6 (end of treatment (EOT)))
Change from Baseline to EOT in an Attention Composite of a Cognitive Test Battery (CTB) (Detection, Identification, and One Back tests)
Evaluation of the short-term safety and tolerability of Xanamem
时间窗: 6 Weeks (Baseline to Week 6 (EOT))
Incidence and severity of treatment-emergent adverse events (TEAEs) Incidence of serious adverse events (SAEs) and SUSARs
次要结局
- Determine the effects of Xanamem on depressive symptoms(6 Weeks (Baseline to Week 6 (EOT)))