EUCTR2019-004959-36-NL进行中（未招募）1 期
A proof of concept phase II study with the PDE-4 inhibitor roflumilast in patients with mild cognitive impairment (MCI). - Cognitive effects of roflumilast in MCI patients
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- ZonMw
- 入组人数
- 81
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-50 to 90 years of age;
- •-willingness (both the participant and informal caregiver) to sign an IC;
- •-body mass index (BMI) between 18.5 and 30;
- •-MMSE of 20 or higher;
- •-MCI due to AD diagnosis which includes either increased cerebrospinal fluid (CSF) amyloid-beta marker and/or a positive biomarker of neuronal injury i.e. magnetic resonance imaging (MRI) scan including measurements of decreased hippocampal volume or medial temporal atrophy by volumetric measures or visual rating);
- •-memory performance on the delayed recall in the 15 words VLT of 1-2 standard deviation(s) (SD) below the average.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 81
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 81
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participating in this study: receiving current irradiation, HIV positive, Hepatitis B/C, Normal Pressure Hydrocephalus (NPH), Morbus Huntington, Parkinson's disease, recent Transient Ischemic Attack (TIA) or Cerebrovascular Accident (CVA) (< 2 years), TIA/CVA followed by cognitive decline (within 3 months), COPD, history of schizophrenia, bipolar disorder or psychotic symptoms not otherwise specified or previous treatment for these diseases (lifetime), current affective disorder (i.e. anxiety or major depression), cognitive problems due to alcohol abuse, brain tumor, epilepsy, encephalitis or lack of capacity to consent to participation. Other exclusion criteria are current treatment with (or illicit use of) centrally acting beta-blockers, cannabis, opiates, benzodiazepines, Methylenedioxymethamphetamine (MDMA) and cocaine. Roflumilast is contraindicated in patients with moderate to severe liver impairment, accordingly patients with moderate or major liver impairments will be excluded (e.g. Child-Pugh B and C). Use of medication showing strong inhibition of either CYP3A4 (e.g. clarithromycin and other similar antihistamines) or CYP1A2 (e.g. fluvoxamine, ciprofloxacin and other fluoroquinolones) is also an exclusion criterion because of interference with roflumilast metabolism resulting in reduced therapeutic effectiveness of roflumilast. Individuals with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption will be excluded, as both the placebo and roflumilast contain lactose monohydrate. Additionally, during the period of the present study, participants are not allowed to participate in other drug trials. Lastly, if a participant does not have the possibility to be accompanied at every test session by the same informal caregiver they will be excluded.
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