24-week Open-label Extension Study Evaluating the Effect of PXT00864 in Mild Alzheimer's Disease Patients Further to PLEODIAL-I Completion
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change from Baseline in the total score of the 11-items Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)
研究概览
简要总结
PLEODIAL-II study is an extension of the previous pilot PLEODIAL-I study (CLN-PXT00864-03 protocol) and is designed for the descriptive analysis of patients with mild AD who are exposed to PXT00864 over an additional 24-week period.
详细描述
Patients having completed the previous 12-week PLEODIAL-I study were eligible to receive PXT00864 in this 24-week open-label extension PLEODIAL-II study in order to collect some additional long-term data regarding the safety and the potential effect of PXT00864 on cognitive and behavioural impairments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild Alzheimer's Disease patient who was included in PLEODIAL-I study
- •Mini Mental State Examination (MMSE) score greater or equal to 20
排除标准
- •Patient who was not compliant with the previous PLEODIAL-I study protocol
- •Patient who experienced significant adverse events which necessitated treatment discontinuation during the PLEODIAL-I study
研究组 & 干预措施
PXT00864 Dose 1
1 orange capsule containing 0.4 mg of acamprosate and 1 white capsule containing 6 mg of baclofen are taken orally b.i.d during 24 weeks.
干预措施: PXT00864 (Drug)
PXT00864 Dose 2
1 orange capsule containing 1 mg of acamprosate and 1 white capsule containing 15 mg of baclofen are taken orally b.i.d during 24 weeks.
干预措施: PXT00864 (Drug)
PXT00864 Dose 3
1 orange capsule containing 20 mg of acamprosate and 1 white capsule containing 12 mg of baclofen are taken orally b.i.d during 24 weeks.
干预措施: PXT00864 (Drug)
结局指标
主要结局
Change from Baseline in the total score of the 11-items Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)
时间窗: V5 (study entry), V6 (after 12 weeks), V7 (after 24 weeks)
Scores on the ADAS-Cog range from 0 to 70 with higher scores indicating greater cognitive impairment
Number of Treatment Emergent Adverse Events (TEAEs)
时间窗: throughout the 24-week study period
次要结局
未报告次要终点