Seizure-like Hippocampal Activity in Alzheimer's Disease Neurodegeneration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Number of Participants With Evaluable fMRI Scans
研究概览
简要总结
The main purpose of this research project is to study how seizure-like activity affects the blood flow in the brain of patients with Alzheimer's disease (AD). Changes in blood flow can change memory and thinking ability, as happens in Alzheimer's disease. The investigators are using a study drug called Levetiracetam, which helps control seizure-like activity to see if it can help change the abnormal blood flow in the brain that is seen in some people with Alzheimer's disease.
详细描述
Subjects will make four separate visits to BIDMC. Subject will come to the Clinical Research Center. All of the visits will take around 5 hours apiece.
If subjects agree to be in this study, subjects will be asked to read and sign the consent form. After subjects sign the consent form, the following things will happen:
- Screening Procedures: Screening procedures are tests and procedures that will be done to determine if subjects are eligible to take part in the research study. For this research study, the screening procedures include:
- A thorough medical history. Investigators will ask if subjects have any medical problems. Investigators will ask about subjects Alzheimer's disease and if they have had any seizures.
- A physical examination. Investigators will take your blood pressure and your heart rate. They will examine your heart and lungs and take your height and weight
- Investigators will also assess the subject's nervous system. Investigators will examine subject's speech, memory, strength, coordination, and reflexes.
- Investigators will ask you to take some paper and pencil tests. This will help us to understand your memory and mood
- Subjects will have a blood test to check how your kidneys are functioning.
Subjects may have already had some of these tests done by their doctor when they were diagnosed with Alzheimer's disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets the NINCDS-ADRDA criteria for probable Alzheimer's disease
- •Mild AD (MMSE ≥ 20)
- •Age >= 50 years
- •English as first language
排除标准
- •A history of seizures prior to the onset of AD
- •Familial Alzheimer's Disease due to known genetic mutations
- •Current use of an antiepileptic medication
- •Current use of a medication known to lower seizure threshold (e.g. bupropion or a neuroleptic)
- •Presence of parkinsonism
- •Significant cerebrovascular disease
- •Other Central Nervous System disease (e.g. stroke, severe traumatic brain injury)
- •Major depression or other psychiatric or behavioral disorders (psychosis, agitation)
- •Medical contraindication to MRI (e.g. pacemaker, intraocular or intracranial metallic objects)
- •Severe claustrophobia or inability to lie flat for MRI
- •Known allergy to levetiracetam, or history of previous adverse reaction to levetiracetam
- •Serum creatinine >= 2
- •A score of >9 on the Geriatric Depression Scale
研究组 & 干预措施
High Dose Levetiracetam
Low Dose Levetiracetam administration via IV infusion over 20 min
干预措施: Low/High/Placebo Dose Keppra (Levetiracetam) (Drug)
Low Dose Levetiracetam
High Dose Levetiracetam administration via IV infusion over 20 min
干预措施: Low/High/Placebo Dose Keppra (Levetiracetam) (Drug)
Placebo administration
Saline administration via IV infusion over 20 min
干预措施: Low/High/Placebo Dose Keppra (Levetiracetam) (Drug)
结局指标
主要结局
Number of Participants With Evaluable fMRI Scans
时间窗: 3 MRIs acquired at visit 2,3 and 4 between weeks 1 and 6
Number of participants who had evaluable fMRI scans with arterial spin labeling to measure brain perfusion blood flow changes in specific brain regions, including the hippocampus
次要结局
- Free and Cued Selective Reminding Test(At visits 2,3,4 in weeks 1-6 (one visit per intervention, visits spaced 2 weeks apart))
- Montreal Cognitive Assessment (MoCA)(At visits 2,3,4 in weeks 1-6 (*one visit per intervention, visits spaced 2 weeks apart)
- Trial Making Test Parts A & B(At visits 2,3,4 in weeks 1-6 (*one visit per intervention, visits spaced 2 weeks apart*)
- Phonemic & Category Fluency Test(At visits 2,3,4 in weeks 1-6 (*one visit per intervention, visits spaced 2 weeks apart*)
研究者
Daniel Press
Associate Professor of Neurology
Beth Israel Deaconess Medical Center