Changes of Cerebral Spinal Fluid APPSα Levels Under Oral Therapy With Acitretin 30 mg Daily in Patients With Mild to Moderate Alzheimer's Disease: a Multicenter Prospective Randomised Placebo-controlled Parallel-group Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Difference in Cerebrospinal Fluid (CSF) Soluble Alpha-clevaed Amyloid Precursor Protein (APPsα) Concentration at Visit 3 Compared to Baseline
研究概览
简要总结
The trials investigates the changes of cerebral spinal fluid (CSF) soluble alpha-secretase cleaved APP (APPsα) levels under oral therapy with acitretin 30mg daily in patients with mild to moderate Alzheimer's disease (AD).The present study aims to demonstrate an enhancement of the α-secretase activity by acitretin as measured by increased CSF APPSα levels in human AD. Second, the safety and tolerability of acitretin in AD patients should be proven.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mild to moderate AD (NINCDS-ADRDA criteria)
- •Mini-Mental State Examination (MMSE): 27-14 points
- •Geriatric Depression Scale ≤ 14
排除标准
- •hereditary cognitive impairment
- •known history of brain injuries
- •Insufficient German language skills
- •actual treatment with other potential disease modifying drugs of AD
- •multimorbidity or significant organ (esp. liver or renal) dysfunction
- •evidence of Non-AD neurodegenerative disorder (e.g. Parkinson)
- •contraindication to acitretin such as osteoporosis, hypoalbuminaemia
研究组 & 干预措施
Acitretin
oral, 30 mg per day, day 1-28
干预措施: Acitretin (Drug)
Placebo
oral, day 1-28
干预措施: Placebo (Drug)
结局指标
主要结局
Difference in Cerebrospinal Fluid (CSF) Soluble Alpha-clevaed Amyloid Precursor Protein (APPsα) Concentration at Visit 3 Compared to Baseline
时间窗: baseline and 4 weeks (visit 3)
Values were assessed via Western blotting technique. Normalization was conducted using hSA levels of the individual samples.
次要结局
未报告次要终点
研究者
K. Lieb
Herr Univ.-Prof. Dr. med. Andreas Fellgiebel
Johannes Gutenberg University Mainz