A Global Phase 3, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Oral Dimebon in Patients With Mild-to-Moderate Alzheimer's Disease (CONNECTION)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 598
- 主要终点
- To determine the effect of Dimebon as compared to placebo on the primary measure of cognition and memory, the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog).
研究概览
简要总结
The Connection Study is a six-month confirmatory Phase 3 study to determine the safety and efficacy of Dimebon in the treatment of mild-to-moderate Alzheimer's disease (AD).
详细描述
This study is a randomized, placebo-controlled 6-month study designed as an adequate and well-controlled trial to demonstrate the safety and efficacy of Dimebon in the treatment of patients with mild-to-moderate AD. Dimebon is an investigational drug for Alzheimer's disease. The target of Dimebon's mechanism of action are the mitochondria (a cell's primary source of energy).The Connection Study is the second of two pivotal studies evaluating the effect of Dimebon. It is a 6-month study enrolling 525 patients in the United States, Europe, and South America. All patients completing the 6-month study will be eligible to receive Dimebon in an open-label extension trial.
The patient population will be carefully selected to ensure inclusion of patients with AD, rather than other types of dementia. Mild-to-moderate disease will be defined by the screening Mini-Mental State Examination (MMSE). Patients will attend study visits with caregivers who will provide information about the patient's condition.
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
- •Mild-to-Moderate Alzheimer's disease
- •Probable AD (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) and Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV)
- •MMSE score 10-24 inclusive
- •Computerized tomography (CT) san or magnetic resonance imaging (MRI) consistent with AD
- •Caregiver who cares for the patient at least 5 days per week
排除标准
- •Anti-dementia drugs including cholinesterase-inhibitors or N-methyl-D-aspartate receptor (NMDA) receptor antagonists within 90 days
- •Other causes of dementia
- •Other primary psychiatric or neurological disorders
- •Unstable medical illnesses or significant hepatic or renal disease
研究组 & 干预措施
A
Dimebon, 5 mg orally three times daily
干预措施: Dimebon (Drug)
B
Dimebon 20 mg orally three times daily
干预措施: Dimebon (Drug)
C
Placebo orally three times daily for six months
干预措施: Placebo (Drug)
结局指标
主要结局
To determine the effect of Dimebon as compared to placebo on the primary measure of cognition and memory, the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog).
时间窗: Week 26
To determine the effect of Dimebon as compared to placebo on the primary measure of global function, the Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus).
时间窗: Week 26
次要结局
- To determine the effect of Dimebon as compared to placebo on a measure of self care and daily function, the Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL).(Week 26)
- To determine the effect of Dimebon as compared to placebo on a measure of behavior, the Neuropsychiatric Inventory (NPI).(Week 26)