Open-Label Extension Study of 23 mg Donepezil SR in Patients With Moderate to Severe Alzheimer's Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 915
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of long-term administration of 23 milligram (mg) donepezil sustained release (SR) in participants with moderate to severe Alzheimer's disease. Participants who complete study E2020-G000-326 (NCT00478205) with no ongoing serious adverse events (SAEs) and no serious adverse drug reactions will be eligible to enter the open-label extension study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 91 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Donepezil SR 23 mg (Donepezil SR 23 mg in Study NCT00478205)
Donepezil SR 23 mg once daily orally for 12 months to participants who received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326 (NCT00478205).
干预措施: Donepezil (Drug)
Donepezil SR 23 mg (Donepezil IR 10 mg in Study NCT00478205)
Donepezil SR 23 mg once daily orally for 12 months to participants who received donepezil 10 mg immediate release (IR) in the preceding double-blind study E2020-G000-326 (NCT00478205).
干预措施: Donepezil (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs)
时间窗: From the enrollment of the study up to 30 days after last dose of the study drug (up to 2 years 3 months)
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product, a change in treatment, or discontinuation of study drug, recurrence of an intermittent medical condition not present pretreatment, an abnormal laboratory test result was considered an AE if the identified laboratory abnormality led to any type of intervention, withdrawal of study drug, or withholding of study drug, whether prescribed in the protocol or not. All AEs in Study 328 (NCT00566501) excluding treatment-emergent signs or symptoms continuing from Study 326 (NCT00478205) were reported.
次要结局
- Percentage of Participants With at Least 1 TEAVs for Selected Parameters: Clinical Chemistry(From the first dose of study drug up to 2 years 3 months)
- Percentage of Participants With at Least 1 Treatment-Emergent Abnormal Laboratory Values (TEAVs): Hematology(From the first dose of study drug up to 2 years 3 months)
- Change From Baseline in Severe Impairment Battery (SIB) Total Score(At Baseline, Month 3, Month 6, Month 9 and Month 12)
- Change From Baseline in Mini-Mental State Examination (MMSE) Total Score(At Baseline, Month 3, Month 6, Month 9 and Month 12)
- Change From Baseline in Quality of Life-Alzheimer's Disease (Qol-AD) Total Score(At Baseline, Month 6 and Month 12)
- Goal Attainment Scaling (GAtS) Score Total Score(At Months 6 and 12)
- Number of Participants With Treatment Outcome Scale (TOS) Score(At Months 6 and 12)
- Change From Baseline in Modified Alzheimer's Disease Cooperative Study Activities of Daily Living Severe Scale (ADCS-ADL) Total Score(At Baseline, Month 3, Month 6, Month 9 and Month 12)
- Change From Baseline in European Quality of Life-5 Dimension (EQ-5D) Total Score(At Baseline, Month 6 and Month 12)
- Change From Baseline in Screen for Caregiver Subjective Burden (SCB) Total Score(At Baseline, Month 6 and Month 12)
- Change From Baseline in Screen for Caregiver Objective Burden (SCB) Total Score(At Baseline, Month 6 and Month 12)