Methylphenidate for Apathy in Alzheimer's Dementia: A Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Apathy Evaluation Scale Score at 12 Weeks
研究概览
简要总结
The purpose of the study is to determine the efficacy of methylphenidate over placebo in treating apathy in patients with Alzheimer's dementia. Apathy is one of the earliest and most profound disturbances that occur in Alzheimer's dementia (AD).
Hypotheses: 1. Methylphenidate (MPH) will improve apathy significantly more than placebo in AD.
- Successful treatment of apathy will improve Instrumental Activities of Daily Living (IADLs), and caregiver burden.
详细描述
Objective: Apathy is one of the earliest and most profound disturbances that occur in Alzheimer's dementia (AD). Based on promising preliminary data from our open-label pilot study we propose a double blind, placebo-controlled randomized clinical trial of methylphenidate for treatment of apathy in AD.
Research Design: Randomized double blind, placebo-controlled study which will evaluate the effect of methylphenidate on apathy and also the impact of improvement of apathy on caregiver burden and functional status.
Hypotheses: 1. Methylphenidate will improve apathy significantly more than placebo in AD.
- Successful treatment of apathy will improve Instrumental Activities of Daily Living (IADLs), and caregiver burden.
Methodology: 60 patients with apathy in the context of AD will be recruited over the next three years. In our proposed study patients will be recruited from relevant clinics at the Omaha Veterans Affairs Medical Center (VAMC) including clinics in Geriatric Psychiatry, Neurology, Primary Care and Geriatric Medicine. 30 patients each with AD and apathy will be randomly assigned to placebo or MPH. All patients in the methylphenidate arm will be started at 5mg twice daily and titrated to 10mg twice daily at two weeks. Patients will be continued in this arm for 12 weeks followed by a 2-week discontinuation phase. Patients will be assessed on regular intervals using the Apathy Evaluation Scale, Instrumental Activities of Daily Living, Zarit Burden Scale and Mini Mental State Examination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of dementia of the Alzheimer type (DSM-IV Text Revision (TR) criteria)
- •Mini-mental state examination (MMSE) >18, but <29
- •Apathy Evaluation Scale (AES) score of more than 40
- •Ability to provide informed consent by either the patient or caregiver.
- •If subjects are being treated with antidepressants, they should be on a stable dose of antidepressants for at least two months prior to the enrollment into the study.
- •If subjects are being treated with cholinesterase inhibitors and memantine, they should be on stable dose of those medications at least four months prior to the enrollment into the study.
排除标准
- •Patient currently taking methylphenidate or hypersensitivity or prior significant adverse events with methylphenidate.
- •Patients currently taking Adderall (amphetamine mixed salts) or Dexedrine (dextroamphetamine sulphate) or any other amphetamine product.
- •Uncontrolled hypertension (BP > 140/90) or tachycardia (100) at screening visit
- •Patients with frontotemporal dementia
- •Patients meeting criteria for Major Depressive Disorder on the Mini International Neuropsychiatric Inventory (MINI)
- •Patients with active psychosis as determined by MINI
- •Patients currently being treated with antipsychotics
- •History of uncontrolled seizure disorder
- •History of malignant hypertension, symptomatic cardiovascular disease, cardiomyopathy, known structural cardiac defect or medically unstable arrhythmias.
- •History of Tourette's syndrome or presence of motor tics
- •Patients with glaucoma
- •Patients taking monoamine oxidase inhibitors (MAOIs)
- •Patient taking clonidine
研究组 & 干预措施
Arm 1
Methylphenidate
干预措施: Methylphenidate (Drug)
Arm 2
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Apathy Evaluation Scale Score at 12 Weeks
时间窗: At 12 weeks
The Apathy Evaluation Scale (AES) has been specifically developed to assess apathy and discriminate it from depression. This 18 item scale with score ranging from 18 to 72, assesses apathy in behavioral, cognitive and emotional domains over the previous four weeks. Higher scores indicate worsening apathy.
次要结局
- Clinical Global Impression(At 12 weeks)
- Mini-mental State Examination (MMSE) at 12 Weeks(At 12 weeks)