NL-OMON54654招募中2 期
A proof of concept phase II study with the PDE-4 inhibitor roflumilast in patients with mild cognitive impairment (MCI) - ROMEMA
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 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
- 年龄范围
- 18 至 99（—）
入选标准
- •- Between 50 and 90 years of age
- •- Willingness (including informal caregiver) to sign an informed consent
- •- Body mass index (BMI) between 18.5 and 35
- •- Mini Mental State Examination (MMSE) of 20 or higher
- •- Clinical Dementia Rating global score of 0.5 or 1
- •- Mild Cognitive Impairment (MCI) diagnosis: memory performance on the delayed
- •recall in the clinically relevant 15 words verbal learning test (VLT) has to be
- •1 standard deviation or more below the average, as well as a global clinical
- •dementia rating (CDR) scale score of 0.5 or 1. In addition mild dementia
- •(probable AD dementia) is defined as the Clinical Core Criteria of McKahn in
- •1987, updated in 2011.
排除标准
- •A potential subject who meets any of the following criteria will be excluded
- •from participating in this study: current irradiation, participants positive
- •for human immunodeficiency virus (HIV)/AIDS and 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 (gold criteria 3
- •and 4), severe 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. Other exclusion criteria are
- •current treatment with (or illicit use of) 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
相似试验
进行中（未招募）
1 期
Cognitive effects of roflumilast in patients with mild cognitive impairment (MCI).EUCTR2019-004959-36-NLZonMw81
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)NL-OMON24630ZonMw81
招募中
2 期
A proof of concept phase II study with the PDE4 inhibitor roflumilast in people suffering from long-term cognitive sequela after strokecerebrovascular accident10007963strokeNL-OMON52276niversiteit Maastricht100
进行中（未招募）
1 期
The effect of lanreotide on therapy resistant gastro-esophageal refluxpatients with persistent endoscopic reflux in spite of maximal medical therapy with PPI 2 x 40 mg pantoprazole before breakfast and dinner and 300 mg of H2 blocker ranitidine at bedtime AND continuing pathological reflux proven on impedancemetry.MedDRA version: 14.1Level: LLTClassification code 10017924Term: Gastroesophageal refluxSystem Organ Class: 100000004856EUCTR2013-004232-29-BEZ Brussel15
已完成
4 期
A Phase 3 and 4 Prospective Study to Characterize the Pharmacokinetics of Alglucosidase Alfa in Patients with Pompe DiseaseCTRI/2014/11/005189Genzyme Corporation4