A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 26-Week Trial To Evaluate The Efficacy And Safety Of Dimebon In Patients With Moderate-To-Severe Alzheimer's Disease
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Change From Baseline in the Severe Impairment Battery (SIB) Score at Week 26
研究概览
简要总结
No Dimebon clinical data exist yet in patients with disease that has advanced to the moderate-to-severe stage. Therefore, this study evaluates the safety and efficacy of Dimebon in patients with moderate-to-severe AD who are receiving existing background therapy with memantine.
详细描述
This study was terminated on May 7, 2010 due to modification of the dimebon development plan following the lack of demonstration of efficacy in the completed DIM14 (CONNECTION) Study. The study was not terminated due to any safety findings. Dimebon has been well-tolerated in clinical trials. Demonstration of efficacy for dimebon in Alzheimer's disease is pending completion of the ongoing DIM18 (CONCERT) Study.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Are men and women ≥ 50 years of age with a diagnosis of Alzheimers disease.
- •Have a Mini-Mental State Exam between 5 and 14 inclusive.
- •Have been taking the medication memantine (ie., Namenda) for at least six months prior to this study.
- •Must have a caregiver who assists the patient at least five days per week for at least three hours per day, who can accompany patient to study visits, and who has an intimate knowledge of the patient's health states and personal care.
排除标准
- •Have taken medicines for Alzheimers disease other than memantine (e.g., donepezil, rivastigmine, galantamine, tacrine) within 2 months prior to this study.
- •Dementia other than Alzheimers disease.
- •Any medical condition or reason that interferes with the ability of the patient to participate in or complete the trial or places the patient at undue risk, as judged by the study doctor.
研究组 & 干预措施
Dimebon
干预措施: Dimebon 20 mg po TID (Drug)
Placebo
干预措施: Placebo po TID (Drug)
结局指标
主要结局
Change From Baseline in the Severe Impairment Battery (SIB) Score at Week 26
时间窗: Baseline, Week 26
SIB developed for evaluation of cognitive function in participants, who demented to a degree that they cannot complete conventional neuropsychological testing. Test items consisted of simple, one-step commands presented with gestural cues and instructions that were repeated if necessary. SIB test consisted of 51-item scale, divided into 9 subscales: social interaction (0-6), memory (0-14), orientation (0-6), language (0-46), attention (0-6), praxis(0-8), visuospatial ability(0-8), construction(0-4), orienting to name(0-2). Total possible score:0-100; lower score = greater cognitive impairment.
Change From Baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living (Severe) (ADCS-ADLsev) Score at Week 26
时间窗: Baseline, Week 26
ADCS-ADLsev: 19-item scale measures basic and instrumental abilities in participant population and had good metric properties and reliability in detecting change. Individual score range: 0 to 5 for telephone, 0 to 4 for dressing, watch television, get around outside home, 0 to 3 for eating, walking, toilet, bathing, grooming, conversation/small talk, clear dishes, find personal belongings, obtain beverages, dispose of garbage, left on own, 0 to 1 for run water from and turn off faucet to wash hands, turn on and off light. Total score range: 0 to 54 lower scores=greater functional impairment.
次要结局
- Change From Baseline in the Neuropsychiatric Inventory (NPI) Total Score at Week 26(Baseline, Week 26)
- Sum of the Delusions and Hallucinations Sub-domain Scores of the NPI(Week 26)
- Change From Baseline in the Mini-Mental State Examination (MMSE) Score at Week 26(Baseline, Week 26)
- Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Scores(Week 26)
- Resource Utilization in Dementia-Lite Version (RUD-Lite)(Baseline, Weeks 12, 18, 26)
- Euro Quality of Life - 5 Domain (EQ-5D) Assessment(Baseline, Weeks 12, 26)
- Population Pharmacokinetic (PK) Analysis(Pre-dose, 0.5 to 1.5 hours, 2.5 to 3.5 hours post-dose at Week 12)
- Number of Participants With Adverse Events (AEs)(Baseline up to Week 30 (follow-up))