NL-OMON24630招募中不适用
A proof of concept phase II study with the PDE-4 inhibitor roflumilast in patients with mild cognitive impairment (MCI)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 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
入排标准
入选标准
- •MCI due to AD diagnosis (diagnosis not older than 1 year), which includes either increased cerebrospinal fluid (CSF) Abeta 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),
- •and a memory performance on the delayed recall in the 15 words VLT of 1-2 standard deviation(s) (SD) below the average.
- •- BMI between 18.5 and 30
- •- Age between 50 and 90 years
- •- (The same) informal caregiver for each test day
- •- MMSE of 20 or higher
- •- Willingness (both the participant and informal caregiver) to sign an informed consent
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participating in this study:
- •- Participants positive for human immunodeficiency virus (HIV) and Hepatitis B & C
- •- Normal Pressure Hydrocephalus (NPH)
- •- Morbus Huntington
- •- Parkinson's disease
- •- Recent Transient Ischemic Attack (TIA)
- •- Cerebrovascular Accident (CVA) (< 2 years)
- •- TIA/CVA followed by cognitive decline (within 3 months)
- •- COPD, asthma
- •- 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
- •- Current treatment with (or illicit use of) centrally acting beta-blockers, cannabis, opiates, benzodiazepines, Methylenedioxymethamphetamine (MDMA) and cocaine.
- •- Use of medication showing strong inhibition of either CYP3A4 (e.g. clarithromycin, erythromycin and other antibiotics) 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 (i.e. retraction informed consent) they will be excluded.
研究者
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