A Randomized, Placebo-Controlled, Double-Blind Study of ATH-1017 Treatment in Subjects With Parkinson's Disease Dementia or Dementia With Lewy Bodies
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 10
- 主要终点
- Global Statistical Test (GST) Score at Baseline
研究概览
简要总结
This study is designed to evaluate the safety and treatment effects of fosgonimeton (ATH-1017) in subjects with Parkinson's Disease Dementia or Dementia with Lewy Bodies, with a randomized treatment duration of 26 weeks.
详细描述
The study is designed to evaluate the safety and treatment effects of ATH-1017 in subjects with Parkinson's Disease Dementia or Dementia with Lewy Bodies, with a randomized, double-blind, placebo-controlled, parallel-arm treatment duration of 26 weeks.
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
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with confirmed diagnosis of Parkinson's disease or Dementia with Lewy Bodies
- •MoCA score 11 to 23, inclusive, at screening
- •Probable Parkinson's Disease Dementia or Lewy Body Dementia
- •BMI between ≥ 16and ≤ 35 kg/m2 for females and between≥ 18 and ≤ 35 kg/m2 for males at Screening
- •Reliable and capable support person/caregiver, who is willing to accept responsibility for supervising the treatment or, if required, administering study drug, and assessing the condition of the subject throughout the study in accordance with all protocol requirements
排除标准
- •Hoehn-Yahr stage 5
- •History of significant neurological disease other than PDD or DLB that may affect cognition at onset of dementia
- •Subjects on deep brain stimulation
- •History of brain MRI scan indicative of any other significant abnormality
- •History of unexplained loss of consciousness, and epileptic fits
- •Hearing test result considered unacceptable for auditory ERP P300 assessment
- •Diagnosis of severe major depressive disorder even without psychotic features (GDS score [15-item scale] >7 at Screening)
- •Significant suicide risk based on C-SSRS
- •Significant psychosis (according to Diagnostic and Statistical Manual of Mental Disorders)
- •Moderate or severe substance abuse disorder (according to DSM-5)
- •Myocardial infarction or unstable angina within the last 6 months
- •Clinically significant cardiac arrhythmia (including atrial fibrillation), cardiomyopathy, or cardiac conduction defect (note: pacemaker is acceptable)
- •Clinically significant ECG abnormality at Screening
- •Chronic kidney disease (eGFR < 45 mL/min using Cockcroft-Gault formula)
- •Hepatic impairment with alanine aminotransferase or aspartate aminotransferase > 2 times the upper limit of normal, or Child-Pugh class B and C
- •Malignant tumor within 3 years before Screening
- •Memantine at any dose or combination
- •Donepezil at 23 mg
研究组 & 干预措施
40mg Dose
Daily subcutaneous injection of 40mg ATH-1017
干预措施: ATH-1017 (Drug)
70mg Dose
Daily subcutaneous injection of 70mg ATH-1017
干预措施: ATH-1017 (Drug)
Placebo
Daily subcutaneous injection of Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Global Statistical Test (GST) Score at Baseline
时间窗: Baseline
The Global Statistical Test (GST) score is a composite of the change from baseline (CFB) z-scores to Week 26 in the Alzheimer's Disease Assessment Scale - Cognitive Subscale, 13-Item Version (ADAS-Cog13; range 0-85; higher scores indicate greater impairment) and Event Related Potential P300 Latency (ERP P300; longer latency (milliseconds) indicates greater impairment). This composite approach was used to assess overall change in disease status and treatment effects of ATH-1017. The GST score was defined as a single outcome variable based on standardizing and combining individual patient-level z-score of change from baseline cognition (ADAS-Cog13) and ERP P300 latency scores. The between-group difference was calculated by subtracting the mean GST score for placebo from the mean GST score for ATH-1017. A negative value based on GST scores (ATH-1017 minus placebo) indicates a favorable response to ATH-1017, while a positive value favors placebo.
次要结局
- Event-related Potential (ERP) P300 Latency at Baseline(Baseline)
- Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13) at Baseline(Baseline)