A Randomized, Double-blind, Placebo Controlled, Dose Ranging Study to Assess the Safety, Tolerability, and Efficacy of HTL0018318 in Patients With Dementia With Lewy Bodies
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 3
- 主要终点
- Incidence and severity of treatment related adverse events
研究概览
简要总结
To establish the safety and efficacy of HTL0018318 compared with placebo when administered once daily for 12 weeks to patients with dementia with Lewy bodies.
详细描述
To assess the safety, tolerability and efficacy of HTL0018318 at 3 dose levels (once daily) compared with placebo over a 12-week treatment period in patients with dementia with Lewy bodies (DLB). Approximately 140 DLB patients who have not received donepezil (Aricept®) and/or other acetyl cholinesterase inhibitors (AchEi) and approximately 32 DLB patients who have had prior treatment experience with donepezil but have stopped usage will be enrolled.
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
- Double (Participant, Investigator)
盲法说明
Double blind
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
- •Diagnosed with probable DLB according to the fourth revision of consensus diagnostic criteria for DLB.
- •Clinical imaging evidence from either SPECT or MIBG cardiac scintigraphy that is consistent with a clinical diagnosis of DLB.
- •Partner or caregiver able to support the patient for the duration of the clinical trial.
排除标准
- •Patients with a diagnosis of Parkinson disease at least 1 year prior to onset of dementia.
- •Patients with the presence of severe extrapyramidal symptoms
- •Patients with the presence of an illness/condition apart from DLB that could contribute to cognitive dysfunction
- •Patients with poorly controlled hypertension despite lifestyle modifications and/or pharmacotherapy, who are currently on more than 2 different antihypertensive treatments
- •Patients with prominent, recurrent episodes of syncope are related to orthostatic hypotension
- •Patients with pulmonary disease or evidence of clinically significant moderate or severe pulmonary symptoms
- •Patients who are taking a range of prohibited and restricted medication
- •Patients who have been prescribed individualised cognitive rehabilitation, stimulation or training that was performed under medical supervision in the 6 months prior to the screening visit
- •Patients who have any known condition(s) that may be contraindicated or interfere with the completion of the nuclear imaging scans.
研究组 & 干预措施
HTL0018318 low dose
oral capsule, once daily
干预措施: HTL0018318 (Drug)
Placebo
oral capsule, once daily
干预措施: Placebo (Drug)
HTL0018318 high dose
oral capsule, once daily
干预措施: HTL0018318 (Drug)
HTL0018318 mid dose
oral capsule, once daily
干预措施: HTL0018318 (Drug)
结局指标
主要结局
Incidence and severity of treatment related adverse events
时间窗: Baseline to 12 weeks
Comparison of HTL0018318 treatment with placebo
Change in systolic, diastolic blood pressure and heart rate
时间窗: Baseline to 12 weeks
Comparison of HTL0018318 treatment with placebo
次要结局
- Change from baseline in measures of psychosis (i.e. hallucinations and delusions)(Baseline to 12 weeks)
- Change from baseline in measures of cognitive impairment(Baseline to 12 weeks)