Can Methylphenidate (Ritalin) Improve Memory and Attention in Mild Cognitive Impairment? A Combined Behaviour-EEG Study
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Verbal Learning Test Immediate Recall
研究概览
简要总结
Traditionally, memory impairments in the elderly population are treated using cholinesterase inhibitors, although impairments remain after treatment. Dopamine (DA) is also involved in cognition and is especially of interest in healthy ageing because of the role in processing speed and cognitive control. To what extent dopamine treatment improves memory and attention in older impaired individuals is unknown. However, such an effect is conceivable because of the close relationship between memory and attention in aging and since improved processing speed and cognitive control may lead to improved memory.
The investigators aim to examine, in the impaired older population, whether a treatment using methylphenidate, a DA re-uptake inhibitor that enhances DA, improves attention and memory. The study will be conducted according to a cross-sectional, double-blind, placebo-controlled, 2-way cross-over design. 20 male and female patients with Mild Cognitive Impairment (MCI), amnestic type, aged above 60 years of age; 20 male and female patients with MCI, non-amnestic type, will be recruited from the Orbis Medical Centre. Participants will be treated once with 20 mg methylphenidate (MPH) and once with placebo. All medications will be administered orally with a capsule. The treatment order will be established by counterbalancing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant has been diagnosed with Mild Cognitive Impairment, either of the amnestic or the non-amnestic type.
- •In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
- •The participant signs and dates a written informed consent form.
- •The volunteer is male or female.
- •The participant is aged 60 to 80 years, inclusive, at the time of informed consent.
- •The participant has a body mass index of 18.5-30, inclusive, at medical screening.
- •The volunteer is healthy, i.e. absence of all exclusion criteria and has normal static binocular acuity (corrected or uncorrected) as well as normal hearing (using a whisper test during medical screening).
排除标准
- •The subject has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality which may impact the ability of the subject to participate or potentially confound the study results.
- •The volunteer has uncontrolled existing major psychiatric symptoms.
- •The subject has uncontrolled hypertension.
- •The volunteer has hyperthyroidism.
- •The participant has known hypersensitivity to any component of the formulation of MPH or related compounds.
- •The participant has glaucoma.
- •The subject has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the first visit or is unwilling to agree to abstrain from alcohol from 24 hours prior to each test day and/or drugs throughout the study.
- •The participant has any sensory or motor deficits which could reasonably be expected to affect test performance.
研究组 & 干预措施
Ritalin
Methylphenidate, capsule, 20 mg, single oral administration
干预措施: Methylphenidate (Drug)
结局指标
主要结局
Verbal Learning Test Immediate Recall
时间窗: 140 min after drug intake
Amplitude of the N400 and P600 event-related potential (ERP) components
时间窗: 140-190 min after drug intake
during encoding and recognition of words of VLT, measured with EEG
Verbal Learning Test Delayed Recall
时间窗: 175 min after drug intake
Verbal Learning Test Recognition
时间窗: 180 min after drug intake
Accuracy and reaction time
次要结局
- Amplitude of ERP components during the visual and auditory N-back test(150-165 minutes after drug intake)
- Performance on visual and auditory N-back test(150 minutes after drug intake)
- Performance on a sustained attention to response task (SART)(165 minutes after drug intake)
- Performance on a motor task(170 minutes after drug intake)
- Amplitude of ERP components during SART(165 - 170 minutes after drug intake)