Improving Function, Quality of Life, Glycemia in Diabetics With Dementia
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Hemoglobin A1C as a Marker for Glycemic Control
研究概览
简要总结
The primary purpose of this study is to determine if the study medication Methylphenidate (Ritalin) will improve subject's blood-sugar control by improving their motivation more than placebo. The secondary objectives of the study are to determine if daily functioning and quality of life improves with methylphenidate treatment.
详细描述
A total of 50 subjects will be enrolled in this study. This study is being conducted at two sites, UNMC and the Omaha VA Medical Center.
The subject will be asked to take the study drug in the form of a capsule to be taken twice daily. Whether the subject receives methylphenidate or placebo (a pill that has a similar appearance to the study drug, but has no medicine) will be determined by random chance. The probability that the subject will receive methylphenidate is 1 in every 2 subjects or 50% of the time. Subjects receiving methylphenidate will be starting at 5 milligrams (mg) twice daily. Dosage will then be increased to 10mg twice daily at 2 weeks.
After the initial visits, the subjects will be asked to come for follow-up every month for the next 4 visits (sixteen weeks total). During each visit subjects will again be asked questions to assess their motivation, memory, functional status and quality of life. Blood will be drawn and an electrocardiogram (ecg/ekg) will be taken to assess the patient's safety twice during the study.
Partial Compensation may be available for participation.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 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 (Diagnostic and Statistical Manual-IV Text Revision (DSM-IV TR) criteria)
- •Diagnoses of diabetes mellitus type II
- •Poor glycemic control (Hemoglobin A1c (HbA1c ≥ 7.0%))
- •Mild to Moderate Alzheimer's dementia (Mini Mental State Examination (MMSE) >18, but <29)
- •Apathy Evaluation Scale (AES) score of more than 30
- •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.
- •Subjects should be on stable dose of statins and ACE inhibitors for ≥ 2 months.
- •Subjects should be on stable dose of diabetes treatment for 2 months prior to enrollment.
排除标准
- •Severe dementia (MMSE < 18)
- •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
- •Patients being treated with insulin pump
研究组 & 干预措施
Methylphenidate
Subject will receive 5mg BID for the first two weeks then 10mg BID until week 16 of the study.
干预措施: Methylphenidate (Drug)
Placebo
Standard inactive pill.
干预措施: Placebo (Drug)
结局指标
主要结局
Hemoglobin A1C as a Marker for Glycemic Control
时间窗: 16 weeks
Hemoglobin A1C (HbA1c) will be used as marker for glycemic control. It is accepted as the best marker for glycemic control in the previous 120 days. Changes in HbA1c are clinically meaningful.
次要结局
- Apathy Evaluation Scale-Clinician (AES-C)(16 weeks)
- Clinical Global Impression (CGI) Scale(16 weeks)
- Instrumental Activities of Daily Living (IADL) Scale(16 weeks)