A Randomized, Double-blind, Placebo-controlled, Phase 2, 6-month Study to Evaluate the Safety, Tolerability and Exploratory Efficacy of CT1812 in Subjects With Mild to Moderate Dementia With Lewy Bodies
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 34
- 主要终点
- Number of Study Participants With at Least One Mild, Moderate, or Severe Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
Multi-center, randomized, double-blind, placebo-controlled, 6- month study in subjects with mild to moderate Dementia with Lewy Bodies.
详细描述
The safety and efficacy of CT1812 at doses of 300 and 100mg will be evaluated over a 24 week double-blind treatment period in patient diagnosed with dementia with Lewy bodies.
Patients will be randomized 1:1:1 to placebo, 100mg CT1812 or 300mg CT1812. Oral CT1812 will be taken daily. Subjects meeting eligibility requirement and signing informed consent will be assessed by repeated psychometric/neurologic testing, safety procedures and PK and PD sample collection at defined intervals throughout the study. Plasma and CSF biomarkers will also be followed.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women 50-85 years of age (inclusive), meeting criteria for probable Dementia with Lewy Bodies (DLB).
- •MRI, or CT scan due to contraindication of MRI if approved by medical monitor) obtained during screening consistent with the clinical diagnosis of DLB and without findings of significant exclusionary abnormalities. An historical MRI (or CT scan), up to 1 year prior to screening, may be used if there is no history of intervening neurologic disease or clinical events (such as a stroke, head trauma etc.) and the subject is without clinical symptoms or signs suggestive of such intervening events.
- •MMSE 18-27 inclusive
排除标准
- •Any neurological condition that may be contributing to cognitive impairment above and beyond those caused by the subject's DLB, including any co-morbidities detected by clinical assessment or MRI (or CT scan due to contraindication of MRI, if approved by medical monitor)
- •Screening MRI (or historical MRI or CT scan due to contraindication of MRI if approved by medical monitor) or historical MRI/CT scan, if applicable. of the brain indicative of significant abnormality, including, but not limited to, prior hemorrhage or infarct > 1 cm3, >3 lacunar infarcts, cerebral contusion, encephalomalacia, aneurysm, vascular malformation, subdural hematoma, hydrocephalus, space-occupying lesion (e.g. abscess or brain tumor such as meningioma). If a small incidental meningioma is observed, the medical monitor may be contacted to discuss eligibility.
- •Clinical, laboratory findings or medical history consistent with:
- •Other primary degenerative dementia (fronto-temporal dementia, Huntington's disease, Creutzfeldt-Jakob Disease, Down syndrome, etc.).
- •Other neurodegenerative condition (amyotrophic lateral sclerosis, etc.).
- •Seizure disorder.
- •Other infectious, metabolic or systemic diseases affecting the central nervous system (syphilis, present hypothyroidism, present vitamin B12 or folate deficiency, other laboratory values etc.).
- •Any major psychiatric diagnosis, including schizophrenia, bipolar disorder, and current major depressive disorder as per Diagnostic and Statistical Manual of Mental Disorders Fifth Edition
- •Clinically significant, advanced or unstable disease that may interfere with outcome evaluations.
研究组 & 干预措施
CT1812 300 mg
CT1812 300 mg
干预措施: CT1812 (Drug)
CT1812 100 mg
CT1812 100 mg
干预措施: CT1812 (Drug)
Placebo
Placebo
干预措施: CT1812 (Drug)
结局指标
主要结局
Number of Study Participants With at Least One Mild, Moderate, or Severe Treatment Emergent Adverse Events (TEAEs)
时间窗: Up to 210 Days
All adverse events (AE) summaries were restricted to TEAEs, which were defined as those AEs that occurred on or after the date of first dose and those existing AEs that worsened during the study. If it could not be determined whether the AE was treatment-emergent due to a partial onset date, then it was counted as such. Verbatim terms were mapped to System Organ Class (SOC) and preferred terms using MedDRA version 24.1.
次要结局
- Montreal Cognitive Assessment Scale (MoCA)(Baseline, Day 28, Day 98, and Day 182)
- Epworth Sleepiness Scale (ESS)(Baseline, Day 28, Day 98, and Day 182)
- Clinician Assessment of Fluctuation (CAF)(Baseline, Day 28, Day 98, and Day 182)
- Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC)(Day 28, Day 98, and Day 182)
- ADCS - Activities of Daily Living (ADCS-ADL)(Baseline, Day 28, Day 98, and Day 182)
- Movement Disorder Society - United Parkinson's Disease Rating Scale Part III (MDS-UPDRS Part III)(Baseline, Day 28, Day 98, and Day 182)
- Change From Baseline in the Power of Attention Composite Score of the Cognitive Drug Research (CDR) System Battery(Baseline and Day 182)
- Neuropsychiatric Inventory (NPI-12) - Domain: Total Score A-L (Frequency x Severity)(Baseline, Day 28, Day 98, Day 182)