Assessment of LY451395 for Neuropsychiatric Symptoms of Aggression and Agitation in Alzheimer's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in the 4-Item Agitation/Aggression Subscale of the Neuropsychiatric Inventory (NPI-4 A/A) at Week 12
研究概览
简要总结
The purpose of this study is to determine whether this drug can help symptoms of aggression and agitation in participants with Alzheimer's disease.
详细描述
The primary purpose of this study is to help answer the following research questions:
- Whether this drug can help symptoms of aggression and agitation in participants with Alzheimer's Disease.
- The safety of this drug and any side effects that might be associated with it.
- How this drug compares to placebo.
During the 12-week period of this study, the participant will have an equal chance of receiving 1 of the 2 treatment groups: active drug or placebo.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Community-dwelling participants with a diagnosis of probable Alzheimer's disease (AD) based on disease criteria from the National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) and the Alzheimer's Association. Mini Mental State Examination (MMSE) score from 6 to 26 inclusive; Neuropsychiatric Inventory-10 (NPI-10) total score greater than or equal to
- •Are men or women at least 60 years old.
- •Weight greater than or equal to 45 kilograms (kg).
- •Have clinically significant and persistent verbal or physical agitation and/or verbal or physical aggression behaviors that are disruptive to daily functioning or potentially harmful and occurred at least 3 days per week over the past 4 weeks prior to study entry.
- •Understand English.
- •Have a reliable and actively involved caregiver who must be able to communicate in English and be willing to comply with protocol requirements.
排除标准
- •Meet DSM-IV-TR or Delirium Rating Scale-Revised-98 criteria for delirium.
- •Does not score ≤4 on the Modified Hachinski Ischemia Scale for vascular dementia.
- •Have a magnetic resonance imaging (MRI) or computer tomography (CT) scan on file since the onset of symptoms of AD and performed within the past 24 months that is inconsistent with a diagnosis of AD.
- •Have a current, required use, or expected use of psychoactive drugs or other medications not allowed in this trial.
- •Have currently active significant medical, neurological, or psychiatric problems that are not allowed in this trial or other brain disorders.
- •Have received acetylcholinesterase inhibitor (AChEIs) or memantine for less than 4 months, or have less than 2 months of stable therapy on these treatments by Visit 2.
研究组 & 干预措施
LY451395
3 milligram (mg) LY451395 orally twice daily for 12 weeks; may have been reduced to 1 mg if participant was unable to tolerate
干预措施: LY451395 (Drug)
Placebo
Placebo orally twice daily for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change From Baseline in the 4-Item Agitation/Aggression Subscale of the Neuropsychiatric Inventory (NPI-4 A/A) at Week 12
时间窗: Baseline, Week 12
NPI assessed noncognitive psychopathology in participants with Alzheimer's dementia. A 4-item subscale of the standard 12-item NPI measured the neuropsychiatric symptoms of A/A, with items consisting of agitation/aggression, aberrant motor behavior, irritability/emotional lability, and disinhibition. Scores for each subscale (frequency x severity) were calculated to obtain each item score. The total subscale score ranged from 0 to 48, with higher scores indicating more frequent and/or severe A/A symptoms. If a symptom was not present at all, the site would not enter anything for frequency or severity, and a zero would be imputed for that item. Least Squares (LS) Mean value was adjusted for NPI strata, treatment, pooled site, visit, treatment-by-visit, baseline NPI-4 A/A, and baseline-by-visit interaction.
次要结局
- Mean Change From Baseline in the Neuropsychiatric Inventory (NPI) Depression Domain at Week 12(Baseline, Week 12)
- Mean Change From Baseline in the Neuropsychiatric Inventory (NPI) Psychosis Subscale Score at Week 12(Baseline, Week 12)
- Mean Change From Baseline in 10-Item Version of Neuropsychiatric Inventory (NPI-10) at Week 12(Baseline, Week 12)
- Mean Change From Baseline in Cohen-Mansfield Agitation Inventory-Community Version (CMAI-C) at Week 12(Baseline, Week 12)
- Mean Change From Baseline in Cornell Scale for Depression in Dementia (CSDD) at Week 12(Baseline, Week 12)
- Mean Change From Baseline in Total T-Score in the Frontal System Behaviors Scale (FrSBe) at Week 12(Baseline, Week 12)
- Mean Change From Baseline in Clinical Global Impression-Severity-Agitation/Aggression (CGI-S-A/A) at Week 12(Baseline, Week 12)
- Mean Change From Baseline in Clinical Global Impression-Severity-Global Functioning (CGI-S-GF) at Week 12(Baseline, Week 12)
- Mean Change From Baseline in the 14-Item Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog14) at Week 12(Baseline, Week 12)