A Phase 2b/3, Double-Blind, Placebo-Controlled, Parallel-Group, 36-Week, 2-Arm Trial With an Open-Label Extension Phase to Assess the Safety, Tolerability, and Efficacy of Xanamem® 10 mg Daily in Patients With Mild or Moderate Dementia Due to Alzheimer's Disease
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 247
- 试验地点
- 35
- 主要终点
- Effects of 10 mg Xanamem on integrated cognitive and functional abilities
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 XanaMIA Phase 2b/3 study is to investigate the safety, tolerability, and efficacy of Xanamem in in mild or moderate dementia due to AD. Trial participants will be randomized to either receive 10mg of Xanamem once daily or a placebo for 36 weeks at a 1:1 ratio in a double-blinded fashion. Participants who have completed the main trial will be eligible to participate in an open-label phase, which involves treatment with 10mg Xanamem once daily for a treatment period of up to a maximum of 108 weeks. The OLE is intended to finish when all participants have completed at least 60 weeks of treatment and a follow-up visit 4 weeks later.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 50 years or older, inclusive at the time of Screening.
- •Clinical syndrome of mild or moderate dementia, likely to be due to AD in the opinion of the Investigator, at Screening, including meeting the following criteria:
- •Clinical Dementia Rating (CDR) global score of 0.5 to 1.0
- •Mini-mental state examination (MMSE) score of 18 to 26
- •Magnetic resonance imaging (MRI) or computerized tomography (CT) scan within 1 year prior to randomization that excludes alternative diagnoses for dementia such as large stroke, likely vascular dementia, brain tumor, subdural hematoma, or other non-AD dementia type findings
- •Positive plasma AD biomarker signature at Pre-screening, comprising fasting levels of a tau species protein.
- •If receiving symptomatic AD medications, the dosing regimen must have been stable for 3 months prior to Screening.
- •Has a consenting trial partner who, in the Investigator's judgment, has frequent and sufficient contact with the participant to be able to provide accurate information as to the participant's cognitive and functional abilities. The trial partner must be available to provide information to the Investigator and trial site staff about the participant and agrees to attend all trial site visits in person for scale completion. A trial partner should be available for the duration of the trial. The measure of adequate availability will be at the Investigator's discretion.
- •Participants must be able to comfortably abstain from caffeine intake for 4 hours prior to scheduled cognitive assessments.
- •Smokers are eligible if they are able to comfortably abstain from nicotine / tobacco products for 2 hours prior to scheduled cognitive assessments.
- •Must provide written informed consent to participate in the trial and be willing and able to participate for the maximum of 9 months of treatment and up to 11.5 months of site visits.
排除标准
- •Use of anti-amyloid or anti-tau antibody within 6 months.
- •Diagnosis of a non-AD dementia including traumatic brain injury.
- •Diagnosis of an active major mental illness of concern in the opinion in the Investigator, including major depressive disorder, bipolar illness, or schizophrenia.
- •Participation in another clinical trial of a drug or device
- •Has a body mass index or body weight that will interfere with participation in the trial, including inadequate venous access to complete the trial assessments, to be determined at the discretion of the Investigator.
- •Previous clinically significant systemic illness or infection, including test positive COVID-19, within the past 4 weeks prior to Screening.
- •Clinical diagnosis of Type I or Type II diabetes requiring insulin.
- •Exhibit physical, cognitive, or language impairments, in the opinion of the Investigator, of such severity as to adversely affect the validity of the data derived from the neuropsychological tests.
- •Trial participants with evidence of current infection with HIV, hepatitis B, or hepatitis C.
- •Participants with a history of clinically significant drug abuse or addiction in the past 2 years
- •Evidence or history of alcohol abuse
研究组 & 干预措施
Open label phase
Participants enrolled in the open-label phase after the main trial will receive 10 mg Xanamem, to be administered orally once every morning with or without food
干预措施: Xanamem (Drug)
Placebo
Placebo tablet, to be administered orally once every morning with or without food
干预措施: Placebo (Drug)
10 mg Xanamem
10 mg Xanamem tablet, to be administered orally once every morning with or without food
干预措施: Xanamem (Drug)
结局指标
主要结局
Effects of 10 mg Xanamem on integrated cognitive and functional abilities
时间窗: 36 weeks
Change from Baseline to end of treatment (EOT) in the Clinical Dementia Ratio - Sum of Boxes (CDR-SB). The CDR-SB is calculated as an average score, with lower scores indicating improvement.
Incidence and severity of treatment-emergent adverse events (TEAEs) [safety and tolerability of Xanamem]
时间窗: 36 weeks
Incidence and severity of TEAEs
次要结局
未报告次要终点