NCT02992132终止2 期
A Double-Blind, Placebo-Controlled Study to Examine the Safety and Efficacy of Pimavanserin for the Treatment of Agitation and Aggression in Alzheimer's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 111
- 主要终点
- Cohen-Mansfield Agitation Inventory (CMAI)
研究概览
简要总结
To evaluate the efficacy of pimavanserin compared with placebo in treatment of agitation and aggression after 12 weeks of treatment
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 50 years of age or older
- •Can understand the nature of the trial and protocol requirements and provide signed informed consent
- •from patient, if deemed competent to provide consent
- •from an appropriate person (e.g. patient's Legally Authorized Representative (LAR) with the patient's assent) if patient is deemed not competent to provide informed consent.
- •Has a diagnosis of probable AD according to the National Institute on Aging-Alzheimer's Association (NIA-AA) guidelines
- •Meets criteria for agitation according to the International Psychogeriatric Association (IPA) guidelines
- •Lives at home or in an assisted living or care facility (but has the capacity to visit the clinic as an outpatient). Subjects must have been at their current location for at least 3 weeks prior to Screening and plan to remain at the same location for the duration of the trial.
- •Has a designated study partner/caregiver who is in contact with the patient at least 3 times a week on 3 separate days
- •Female patients must be of non-childbearing potential or must agree to use an acceptable method of contraception or abstinence , for at least 1 month prior to randomization, during the study, and 1 month following completion of the study
- •The patient and caregiver are willing and able to participate in all schedule evaluations and complete all required tests
排除标准
- •The agitation/aggression is attributable to concomitant medications, environmental conditions, substance abuse, or active medical or psychiatric condition
- •Patient is receiving skilled nursing care for any medical condition other than dementia
- •Treatment with an antipsychotic medication within 2 weeks of Baseline visit or 5 half lives, whichever is longer
- •Patient or study partner/caregiver has a medical condition (e.g., hearing, vision impairments) that would impair the ability to perform the study assessments.
- •Has had a myocardial infarction within the last six months
- •Has a history or symptoms of long QT syndrome
- •Has a history of a significant psychotic disorder before or during the diagnosis of probable Alzheimer's disease (including, but not limited to schizophrenia or bipolar disorder)
- •Patient is bedridden or has any significant medical condition that is unstable and would place the patient at undue risk from study drug or study procedures
- •Has a sensitivity to pimavanserin or its excipients
- •Has previously participated in a clinical study with pimavanserin
- •Has a Global Clinician Assessment of Suicidality (GCAS) score of 3 or 4 based on Investigator's assessment of behavior within the last 3 months at Screening or since last visit at Baseline
研究组 & 干预措施
Pimavanserin 34 mg
Experimental
Drug- pimavanserin tartrate, 34 mg, taken as two 17 mg tablets, once daily by mouth
干预措施: Pimavanserin 34 mg (Drug)
Pimavanserin 20 mg
Experimental
Drug- pimavanserin tartrate, 20 mg, taken as two 10 mg tablets, once daily by mouth
干预措施: Pimavanserin 20 mg (Drug)
Placebo
Placebo Comparator
Placebo, taken as two tablets, once daily by mouth
干预措施: Placebo (Other)
结局指标
主要结局
Cohen-Mansfield Agitation Inventory (CMAI)
时间窗: Baseline to 12 weeks
The Cohen-Mansfield Agitation Inventory (CMAI) is a 29-item scale to assess agitation. Each item is rated on a 7-point scale of frequency, from least (1) to most frequent (7). Items are summed to calculate the CMAI total score. The CMAI total score has a range of 29-203 points; higher scores indicate more severe agitation
次要结局
- Zarit Burden Interview(Baseline to 12 weeks)
研究者
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