First Single-blind Sequential Placebo-controlled Prospective Phase IIA Pilot Study Assessing the Effects of PXT00864 in Mild AD Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Number of Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy on cognitive impairment and functioning of several doses of PXT00864 (new fixed combination of acamprosate and baclofen at low dose) in patients with mild Alzheimer Disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Male or female patients aged ≥ 60 years.
- •Patient with a diagnosis of probable AD
- •Progressive decline in cognition for more than six months which story is documented in patient medical records
- •A Mini-Mental State Examination (MMSE) score of 20-26
- •With a minimum of educational background
- •Naïve to anti-dementia treatment
- •MRI assessment which corroborates the clinical diagnosis (hippocampal atrophy) and excludes other potential causes of dementia especially cerebrovascular lesions
- •If available, Cerebral Spinal Fluid (CSF) classical biomarkers should be at levels which corroborate the clinical diagnosis
- •Ambulatory patient living at home with a caregiver available and living in the same household or interacting with the patient daily and available if necessary to ensure administration of the investigational product
- •Absence of major or severe depressive disease
- •Patient with a willingness to participate in this study and who have signed an informed consent form
排除标准
- •Early onset of dementia, i.e. before 60 years old to avoid hereditary AD forms
- •Significant neurological disease other than AD
- •Major psychiatric disorder or syndrome (schizophrenia or bipolar disorder)
- •Seizure disorders
- •Other infectious, metabolic or systemic diseases affecting central nervous system
- •Other active clinically significant illness
- •Hospitalization or change of chronic concomitant medications one month prior to screening
- •Patients with severe respiratory, hepatic or renal failure or with any other significantly potentially disabling abnormality detected during screening
- •Known hypersensitivity to the tested treatment including active substance and excipients.
- •Patients participating in another study and exposed to any investigational therapy within the 30 days prior to the entry in this study.
- •Patient without medical care insurance
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 These 2 capsules are taken orally b.i.d. during 8 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 .
These 2 capsules are taken orally b.i.d. during 8 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 .
These 2 capsules are taken orally b.i.d. during 8 weeks.
干预措施: PXT00864 (Drug)
Placebo of PXT00864
1 orange capsule containing placebo of acamprosate , and 1 white capsule containing placebo of baclofen .
These 2 capsules are taken orally b.i.d. during 4 weeks
干预措施: placebo (Drug)
结局指标
主要结局
Number of Treatment Emergent Adverse Events (TEAEs)
时间窗: throughout the 12-week study period.
Change From Baseline in the total score of the 11-item Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)
时间窗: Visit V0 (train), V1 (baseline), and every 4 weeks (visits V2, V3 and V4)
Scores on the ADAS-Cog range from 0-70 with higher scores indicating greater cognitive impairment.
次要结局
- Change From Baseline in the score of the Free and Cued Selective Reminding Test (FCSRT)(1 (baseline) and V4 (end of study, after 12 weeks of treatment))
- Change From Baseline in the time score of the Trail Making Test - part A(Visit V0 (train), V1 (baseline), and every 4 weeks (visits V2, V3 and V4))
- Change From Baseline in the time score of the Trail Making Test - part B(Visit V0 (train), V1 (baseline), and every 4 weeks (visits V2, V3 and V4))
- Change From Baseline in the score of the Digit Symbol Substitution Test (DSST)(Visit V0 (train), V1 (baseline), and every 4 weeks (visits V2, V3 and V4))
- Change From Baseline in the score of the Clinical Dementia Rating (CDR) scale(1 (baseline) and V4 (end of study, after 12 weeks of treatment))
- Change From Baseline in the speed to perform the Zazzo's Cancellation Test(Visit V0 (train), V1 (baseline), and every 4 weeks (visits V2, V3 and V4))
- Change From Baseline in the score of the Zazzo's Cancellation Test(Visit V0 (train), V1 (baseline), and every 4 weeks (visits V2, V3 and V4))
- Change From Baseline in the score of the 15-second Isaacs Set Test(Visit V0 (train), V1 (baseline), and every 4 weeks (visits V2, V3 and V4))
- Change From Baseline in the score of the Apathy Inventory (AI) scale(1 (baseline) and V4 (end of study, after 12 weeks of treatment))
- Change From Baseline in the score of the 4-item Instrumental Activities of Daily Living scale (IADL-PAQUID)(V0 (train), V1 (baseline), and every 4 weeks (V2, V3 and V4))