NCT05680389招募中1 期
Placebo-controlled, Randomized, Double-blind Study of Minocycline for Sporadic and Hereditary Cerebral Amyloid Angiopathy
Leiden University Medical Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年12月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- inflammatory, vessel integrity and gelatinase pathway associated biomarkers in CSF
研究概览
简要总结
We will perform a randomized clinical trial with minocycline. Minocycline is an antibiotic of the tetracycline family and known to modulate inflammation, gelatinase activity and angiogenesis, which we know are central mechanisms in CAA-pathology. Our aim is to prove in a randomized clinical trial in a translational setting that minocycline treatment (duration 3 months) can decrease markers of neuroinflammation and the gelatinase pathway in the cerebrospinal fluid (CSF) of persons with D-CAA (n=30) and sporadic-CAA (n=30).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years for D-CAA and age ≥55 years for sporadic-CAA
- •Probable-CAA according to the Modified-Boston-Criteria or genetically proven D-CAA
- •≤ 2 ICH (occurrence of ICHs at least 1 year ago) and presence of ≥ 2 lobar microbleeds +/-cortical superficial siderosis
- •Written informed consent
排除标准
- •Previous allergic reactions to minocycline
- •Modified Rankin Score ≥3
- •Contraindications, such as:
- •Contraindications for 7T MRI as determined by the 7Tesla safety committee. Examples of possible contra-indications are: claustrophobia, pacemakers and defibrillators, nerve stimulators, intracranial clips, intraorbital or intraocular metallic fragments, cochlear implants, ferromagnetic implants, hydrocephalus pump, intra-uterine device, permanent make-up, tattoos above the shoulders. In case of specific contra-indications for 7T a 3T will be made instead. - Specific contraindications for checkerboard fMRI: seizure within prior year, photosensitive epilepsy, noncorrectable visual impairment. - Contraindications for lumbar puncture: compression of the spinal cord, signs and symptoms of increased intracranial pressure, local infections of the skin at the puncture site, a coagulopathy or thrombocytopenia (<100). (Use of acetylsalicylic acid, NSAIDs, COX2 inhibitors or low-molecular-weight heparin are no contraindications for lumbar puncture.)
- •Pregnancy/breast feeding
- •Liver/renal failure
- •Use of antibiotics <1 month
- •SLE or other diseases known to generate inflammatory responses
- •Previous/current/planned use of retinoids (since this is related to increasing risk of increased intracranial pressure)
- •Current use of anaesthetics like methoxyflurane, agents inhibiting peristalsis, barbiturates, carbamazepine or fenytoïne
研究组 & 干预措施
Minocycline
Experimental
100 mg twice daily for 3 months
干预措施: Minocycline (Drug)
Placebo
Placebo Comparator
twice daily for 3 months
干预措施: Placebo (Drug)
结局指标
主要结局
inflammatory, vessel integrity and gelatinase pathway associated biomarkers in CSF
时间窗: 3 months
IL6, MCP-1, IBA-1, MMP2/9, and VEGF
次要结局
- safety and tolerability of minocycline(3 months)
- progression of hemorrhagic markers on 7T MRI before and after treatment(3 months)
研究者
Marieke JH Wermer, MD
Prof Wermer
Leiden University Medical Center
研究点 (1)
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