Double-Blind, Positive Comparator, Randomized, Parallel Study of Efficacy, Safety, and Tolerability of AZD3480 (TC-1734-226) as Monotherapy in Patients With Mild to Moderate Dementia of the Alzheimer's Type
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 386
- 试验地点
- 33
- 主要终点
- Change from baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
研究概览
简要总结
Alzheimer's disease is the most common form of dementia and is the fourth leading cause of death among people 65 years of age and older. The global prevalence of the disease will increase significantly as the population ages, unless preventative treatments can be identified and marketed. The present study seeks to evaluate AZD3480 (TC-1734) compared to an approved medication (donepezil) shown to improve cognition and function in patients with Alzheimer's disease.
详细描述
This is a double blind, positive comparator, randomized, multicenter, parallel group study to assess the efficacy, safety, and tolerability of AZD3480 as monotherapy in patients with mild to moderate dementia of the Alzheimer's type (AD). Approximately 300 subjects will be randomized and divided into 2 cohorts. Actual randomization was 293 subjects.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A clinical diagnosis of AD per NINCDS-ADRDA criteria; mild to moderate severity as defined by Mini-Mental State Examination (MMSE) scores of 12 to
- •AD diagnosed at least 12 months prior to Screening, and supported by brain imaging studies within 6 months prior to Screening.
- •Absence of vascular dementia both per AIRENS criteria and as defined by modified Hachinski ischemia score (HIS) of </=
- •Presence of a caregiver with significant proportion of time in contact with subject and who will oversee administration of study drug during the trial
- •Able to complete test assessments and to sign informed consent with the help of a caregiver if needed
排除标准
- •Diagnosis or presence of other dementing illnesses
- •Use of mood stabilizers, antidepressants, anxiolytics, antipsychotics or hypnotics
- •Treatment within 1 month prior to Screening using cognition-affecting agents (e.g. CNS stimulants)
- •Tobacco user within 4 months prior to Screening
- •Use of smoking cessation therapy within 4 months prior to Screening
- •History within past 6 months of alcohol abuse or illicit drug abuse
- •Unable, even with caregiver assistance, to comply with study procedures in opinion of investigator
- •Myocardial infarction within the 12 months prior to Screening
- •Hypothyroidism, vitamin B12 or folic acid deficiency
- •Known systemic infection (HBV, HCV, HIV, TB)
- •Vascular dementia per NINDS-AIRENS criteria and as defined by a modified Hachinski ischemia score (HIS, Appendix 4) score of > 4 (i.e., vascular dementia is consistent with a modified HIS > 4).
研究组 & 干预措施
AZD3480
干预措施: AZD3480 (Drug)
Donepezil
Donepezil will be administered at 5 mg daily for 4 weeks and escalated to 10 mg daily for the remainder of the study.
干预措施: Donepezil (Drug)
结局指标
主要结局
Change from baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
时间窗: 52 Weeks
The ADCS-ADL is the co-primary endpoint with the ADAS-Cog in Europe.
Change from baseline in the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog)
时间窗: 52 weeks
Change from baseline in the Clinician Interview-Based Impression of Change plus carer interview [CIBIC-(+)]
时间窗: 52 Weeks
The CIBIC-(+) is a co-primary endpoint with the ADAS-Cog in the United States.
次要结局
- Change from baseline in the Neuropsychiatric Inventory (NPI)(52 Weeks)
- Change from baseline in the Mini-Mental State Examination (MMSE)(52 Weeks)
- Change from baseline in the Alzheimer's Disease Related Quality of Life (ADRQL)(52 Weeks)