Double-blind Randomised-controlled Within-subject Crossover Trial to Determine Levetiracetam Efficacy for Memory Impairment in Parkinson's Disease: A Proof-of-concept Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Hippocampal DG/CA3 subfield activity
研究概览
简要总结
The present study is a proof-of-concept clinical trial to test the efficacy of low doses of a repurposed anti-epileptic drug (levetiracetam) in treating memory problems in Parkinson's disease (PD). Neuroimaging techniques will be used to determine the effect of the drug on specific brain regions (hippocampal subfields). Finally, baseline brain activity of PD patients with memory problems will be compared to PD patients without memory problems and healthy older adults to determine if activity in specific brain regions (hippocampal subfields) can be used to predict memory problems in PD. This information will be useful for future clinical trials to target drugs to these brain regions.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parkinson's Disease patients with amnestic Mild Cognitive Impairment
- •Parkinson's Disease patients with no memory impairment
- •Healthy volunteers
- •All participants must be eligible to take MRI scans
排除标准
- •Contraindication to having MRI
- •Bipolar disorder, Schizophrenia, Alcohol or substance abuse
- •Major depression
- •Suicidal Ideation
- •Difficulty complying with protocol requirements
- •Significant non-PD neurological disease
- •Vascular dementia
- •Sensitivity to levetiracetam
- •Use of anticonvulsant medications
- •Use of other excluded medications
- •Severe renal impairment
- •Clinically significant abnormalities in B12 or thyroid function test (below normative range for elderly)
- •Females of childbearing potential
研究组 & 干预措施
Active arm
125mg Levetiracetam capsules taken twice daily (morning and evening) for 14 days
干预措施: Levetiracetam (Drug)
Placebo arm
125mg maize starch-based placebo capsules taken twice daily (morning and evening) for 14 days
干预措施: Placebo (Drug)
结局指标
主要结局
Hippocampal DG/CA3 subfield activity
时间窗: Immediately after 2 weeks of treatment
Participants' brain activation during the pattern separation fMRI paradigm, as measured by their activation in the critical dentate gyrus (DG)/CA3 subfield of the hippocampus during the critical "lure" trials of the pattern separation task.
Pattern separation performance (behavioural outcome)
时间窗: Immediately after 2 weeks of treatment
Participants' behavioural performance on the pattern separation fMRI paradigm, as measured by their proportionate accuracy of identifying the critical "lure" trials.
次要结局
未报告次要终点
研究者
Nadeeka Dissanyaka
NHMRC Boosting Dementia Research Leadership Fellow
The University of Queensland