Evaluating cognitive effects of a three month course of methylphenidate in Parkinson's disease patients with mild cognitive impairment.
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
The objective of the current study is to examine the cognitive effects of a three-month course of methylphenidate (MPD) in Parkinson’s disease (PD) patients with mild cognitive impairment (MCI). This study may contribute to determining whether MPD has beneficial effects on cognition and attention in advanced PD patients who exhibit cognitive impairment. To evaluate these effects, we will use objective electrophysiological measures associated with processing of goal-directed contextual information in working memory, an important executive function that has been shown to be deficient in PD. In addition, we will evaluate the effect of MPD on cognitive function and quality of life in the patients, using neuropsychological tests. This will be the first randomized, double-blind, placebo-controlled study, to specifically evaluate the cognitive effects of MPD in PD patients with MCI.
研究设计
- 分配方式
- Randomized
- 主要目的
- Placebo
- 盲法
- Double (Subject, Analyst, Investigator, Carer)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Parkinson's disease patients, 50-80 years old. It will be obligatory for patients to have a good response to levodopa. We will include PD patients with Montreal Cognitive Assessment (MoCA) scores of 20-25, indicating cognitive impairment. No change to PD medications within the month preceding randomization, including starting, stopping, or dosage modifications. Treatment with stable doses of levodopa and cholinesterase inhibitors (ChEIs) is allowable if stable for 3 months before randomization.
排除标准
- •Any change in dopaminergic therapy three months prior or during the study. Previous use of methylphenidate. Patients with clinically significant depression, patients who have suffered from hallucinations/delusions/psychosis, severe motor fluctuations and prominent ON dyskinesia, unbalanced arterial hypertension of more than 140/80, uncontrolled hypertension, hepatic or renal failure, uncontrolled malignancy, or untreated glaucoma, women of childbearing potential (screening will include pregnancy test). Hyperthyroidism, symptomatic cardiovascular disease, serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or a family history of sudden death or death related to heart problems. Patients treated with Monoamine Oxidase Inhibitors (MAOIs), other psychotropic medications, or suspected hypersensitivity to methylphenidate or its excipients.
研究者
secretariageneral
Scientific
Universidad Rey Juan Carlos