NCT04229927Unknown3 期
A Multicenter, Randomized, Double-blind, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of BPDO-1603 in Patients With Moderate-to-severe Alzheimer's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 712
- 试验地点
- 1
- 主要终点
- Change in SIB total scores
研究概览
简要总结
A multicenter, randomized, double-blind, active-controlled, phase III clinical trial to evaluate the efficacy and safety of BPDO-1603 in patients with moderate-to-severe Alzheimer's disease
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A voluntary, written informed consent from the patient or the patient´s representative.
- •Male or female patients ≥ 45 years of age as of the date of informed consent.
- •Diagnosed with probable AD according to the National Institute on Aging-Alzheimer's Association [NIA-AA (2011)] criteria.
- •MMSE score of ≥ 5 and ≤ 20 during screening period.
- •CDR-GS of 2 ~ 3 or GDS of 4 ~ 7 during screening period.
- •Ongoing cholinesterase inhibitor therapy with stable dose of 10 mg/day donepezil hydrochloride for more than 12 weeks (inclusive) prior to screening, and can continue this therapy until randomization without any change in the dosage regimen of donepezil hydrochloride.
排除标准
- •Magnetic resonance imaging (MRI) or computed tomography (CT) findings obtained within the past 12 months (ie, 48 weeks) from screening or at screening, as a cause of dementia other than probable AD.
- •History of other organic disease, such as vascular dementia, CNS infections (e.g., human immunodeficiency virus [HIV], syphilis), head injury, Creutzfeldt-Jakob disease, Niemann-Pick's disease, Huntington's disease, Parkinson's disease, epilepsy, or stroke.
- •Evidence of other neurological disorders which include seizure disorder that may interfere with the patient's cognition or ability to perform the study procedures.
- •Use of Memantine Hydrochloride within 1 month prior to screening
研究组 & 干预措施
Arm 1
Experimental
干预措施: BPDO-1603 (Drug)
Arm 2
Placebo Comparator
干预措施: BPDO-1603 (Drug)
结局指标
主要结局
Change in SIB total scores
时间窗: from baseline to Week 24
CIBIC-plus total score
时间窗: at Week 24 (Baseline score will be from CIBIS
次要结局
未报告次要终点
研究者
研究点 (1)
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