A Multicenter, Randomized, Double-blind, Placebo-controlled, 4-arm, 26 Week Parallel-Group Study to Evaluate Efficacy, Safety and Tolerability of 2 Oral Doses and 2 Regimes of Tideglusib vs Placebo in Mild-to-Moderate AD Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 306
- 主要终点
- ADAS-Cog+
研究概览
简要总结
The main purpose of this study is to evaluate the cognitive changes after administration of tideglusib versus placebo at two oral doses and two treatment regimes for 26 weeks in patients with mild to moderate Alzheimer's disease.
After the 26 week core treatment period, the patients may continue in the study under blinded conditions for an optional extension period up to a maximum of 39 additional weeks (total study duration up to 65 weeks), until the last patient in the study has completed the 26 week of treatment.
详细描述
This double-blind, placebo-controlled, randomized, parallel group study will be conducted at multiple centers in the European Union. Patients with mild to moderate Alzheimer's disease will undergo a screening period, and then they will be randomized to one of these four groups: tideglusib 1000 mg once daily (Q.D.), tideglusib 1000 mg every other day (Q.O.D.), tideglusib 500 mg Q.D., or matching placebo, for a 26-week, double-blind, placebo-controlled treatment period.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women (of non-childbearing potential) with a diagnosis of probable Alzheimer's disease.
- •Age of 50 to 85 years.
- •MMSE score 14 to
- •Well-tolerated treatment with one of the approved Acetylcholinesterase-Inhibitors and/or Memantine in a stable dose
排除标准
- •Significant psychiatric on medical disease.
- •Any chronic liver disease as indicated by out of range values of ALAT, ASAT or direct bilirubin, clinically relevant hepatic steatosis or other clinical manifestations of liver disease
- •Chronic daily drug intake of excluded concomitant medications.
- •Enrollment in another investigational drug study within 3 months before the baseline visit.
研究组 & 干预措施
Tideglusib 1000 mg Q.D.
Group dosed with 1000 mg once daily for 26 weeks/extension
干预措施: tideglusib (Drug)
Tideglusib 1000 mg Q.O.D.
Group dosed with 1000 mg once every other day for 26 weeks/extension
干预措施: tideglusib (Drug)
Tideglusib 500 mg Q.D.
Group dosed with 500 mg once daily for 26 weeks/extension
干预措施: tideglusib (Drug)
Placebo
Once daily administration for 26 weeks/extension
干预措施: Placebo (Drug)
结局指标
主要结局
ADAS-Cog+
时间窗: 26 weeks
The change from Baseline of the 3 active study medication groups will be compared with the placebo group in Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog+)
次要结局
- Adverse events (AEs): Number of AEs and patients with an incidence rate of ≥ 5% AEs(26 weeks)
- Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Alzheimer's Disease Cooperative Study Unit Activities of Daily Living (ADCS-ADL).(26 weeks)
- Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Mini Mental State Examination (MMSE)(26 weeks)
- Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Word Fluency test(26 weeks)
- Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Neuropsychiatric Inventory (NPI)(26 weeks)
- Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Geriatric Depression Scale (GDS)(26 weeks)
- Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Clinical Global Impression of Change (CGIC)(26 weeks)
- Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the European Quality of life Instrument (EQ-5D)(26 weeks)
- Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Caregiver time (RUD Lite)(26 weeks)
- Change from Baseline of the 3 active study medication groups will be compared with the placebo group in the Questionnaire on urinary incontinence(26 weeks)
- Exploratory Endpoints (only in a subgroup of patients at predefined sites): Change from Baseline of the 3 active study medication groups will be compared with the placebo group in levels of τ, phospho-τ, and β-amyloid in CSF and change in MRI measures.(26 weeks)