NCT07832383尚未招募2 期
A Phase 2a, Multicenter, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of NBI-1117567 in Participants With Mild to Moderate Alzheimer's Disease on Stable Treatment With an Acetylcholinesterase Inhibitor
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 135
- 主要终点
- Change From Baseline in Neuropsychological Test Battery (NTB) Composite Score at Day 85
研究概览
简要总结
This study is designed to evaluate the efficacy on improving cognitive performance as well as the safety, tolerability, and pharmacokinetics (PK) of NBI-1117567 administered once daily (QD) in adults with mild to moderate AD who are receiving stable treatment with an acetylcholinesterase inhibitor.
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
- •Participant has a primary diagnosis of mild to moderate AD prior to screening.
- •Participant is receiving a well-tolerated treatment with an acetylcholinesterase inhibitor (donepezil, galantamine, or rivastigmine) at a stable dose for at least 3 months prior to the Screening Visit and is required to continue the same treatment at the same dose level throughout the study.
- •Negative pregnancy test at screening and Day 1 for participants of childbearing potential.
- •Participant is willing and able to comply with all study procedures and restrictions in the opinion of the investigator. Participant can follow instructions and understand and perform all study procedures, including cognitive assessments in the opinion of the investigator.
排除标准
- •Pregnant (that is, positive pregnancy test at screening, or baseline [Day 1]) or lactating, or plans to become pregnant during the study.
- •Participant has other medical or neurological condition or prior clinical findings indicative of alternate or additional causes of cognitive impairment, including but not limited to vascular dementia, multi-infarct dementia, normal pressure hydrocephalus, Parkinson's disease, dementia with Lewy bodies, frontotemporal dementia, multiple sclerosis, amyotrophic lateral sclerosis, hypoxic cerebral damage, encephalitis, central nervous system (CNS) infection, chronic traumatic encephalopathy, and history of head injury with loss of consciousness.
- •Participant has an unstable medical condition within the 3 months prior to screening or clinically relevant medical condition interfering with the study as judged by the investigator, as determined from the medical history review and the physical examinations obtained during screening.
- •Participant has any primary psychiatric condition or severe psychiatric symptom that in the opinion of the investigator may interfere with the participant's ability to participate in the study or impact the interpretation of study results.
- •Participant is undergoing psychological therapy interventions for cognition in AD. Participants undergoing cognitive behavioral therapy for conditions other than AD must be stable for 3 months prior to Day 1 and during the study.
- •Participant has previously participated in an interventional clinical study within the preceding 180 days, or 5 half-lives of the experimental treatment, whichever is longer.
- •Note: Other protocol-defined inclusion and exclusion criteria may apply.
研究组 & 干预措施
NBI-1117567 High Dose
Experimental
Participants will receive the titration dose of NBI-1117567 followed by the target dose (high dose) for 10 weeks.
干预措施: NBI-1117567 (Drug)
Placebo
Placebo Comparator
Participants will receive placebo for 12 weeks.
干预措施: Placebo (Drug)
NBI-1117567 Low Dose
Experimental
Participants will receive the titration dose of NBI-1117567 followed by the target dose (low dose) for 10 weeks.
干预措施: NBI-1117567 (Drug)
结局指标
主要结局
Change From Baseline in Neuropsychological Test Battery (NTB) Composite Score at Day 85
时间窗: Baseline, Day 85
次要结局
- Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score at Day 85(Baseline, Day 85)
- Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale, 13 Item Version (ADAS-Cog13) Score at Day 85(Baseline, Day 85)
研究者
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