Inhibition of α-synuclein Cell-cell Transmission by NMDAR Blocker, Memantine
试验速览
- 阶段
- 3 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Rey Auditory Verbal Learning Test (RAVLT) Scores (baseline to year-1)
研究概览
简要总结
Lewy Body Dementia (LBD), is the second most common form of dementia after Alzheimer's Disease. Dementia is defined as a serious loss in cognitive ability due to damages or disease in the brain beyond what is normal aging. With Lewy Body Dementia, protein deposits, or Lewy Bodies, accumulate in nerve cells throughout the brain, affecting motor control, memory and thinking. LBD can also form with the progression of Parkinson's disease (PD). PD is a degenerative nervous system disorder that affects movement ability. Using more sensitive MRI imaging techniques the investigators are attempting to see if disease progression can be monitored more closely. At the same time, the study medication Memantine will be compared to a placebo to determine if it can be used to slow the progression of PD. The purpose of this study is to assess if disease progression can be better monitored through brain imaging and if Memantine will help slow disease progression.
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
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosed with idiopathic PD for at least 2 or more years
- •45 to 85 years of age
- •Have been on stable doses of anti-Parkinson medication
- •Able to give informed consent
- •Able to undergo brain MRI
- •Unilateral symptoms
- •A score of 26 or greater on the Montreal Cognitive Assessment (MOCA), a measure of a patients short-term memory recall, the ability to determine visual-spatial relationships of objects, attention, concentration, working memory, language and orientation to time and place
- •Use of one method of medically approved contraceptive
排除标准
- •History of any surgical intervention for treating PD (i.e. deep brain stimulation)
- •Extreme physical disability
- •History or current diagnosis of unstable psychiatric condition
- •Presence of dementia or any other condition that prevents the ability of the participant to provide fully informed consent
- •Other brain disease
- •Treatment with Memantine 30 days prior to baseline
- •Females who are pregnant or nursing
- •Presence of interacting medications with Memantine or co-morbid medical conditions that may be exacerbated by this agent
- •Moderately significant drug interactions with Dextromethorphan, Amantadine, Sodium Bicarbonate, and Acetazolamide
- •Previous Allergic reaction to Memantine
- •Any genetic form of PD
研究组 & 干预措施
Memantine
Memantine will be started at 10 mg tablet once/day for a week at bedtime. After one week Memantine will be administered at 10 mg tablet twice/day for 51 weeks.
干预措施: Memantine (Drug)
Placebo
Placebo will be started at 10 mg tablet once/day for a week at bedtime. After one week placebo will be administered at 10 mg tablet twice/day for 51 weeks.
干预措施: Placebo (Other)
结局指标
主要结局
Change in Rey Auditory Verbal Learning Test (RAVLT) Scores (baseline to year-1)
时间窗: Change from baseline RAVLT at year 1
Investigate the effects of Memantine administration on the global cognitive status and executive function
Change in Trail test performance time (baseline to year-1)
时间窗: Change from baseline Trail test at year 1
Investigate the effects of Memantine administration on visual attention and task switching
Change Judgment of Line Orientation test performance score (baseline to year-1)
时间窗: Change from baseline Judgment of Line Orientation test at year 1
Investigate the effects of Memantine administration on visuospatial skills
Change in Stroop Color Word Test performance (baseline to year-1)
时间窗: Change from baseline Stroop Color Word Test at year 1
Investigate the effects of Memantine administration on cognitive interference and processing speed
次要结局
- Change in cortical thickness (Cth), as measured by MRI T1 sequence, in multiple brain regions (mentioned in outcome #5), baseline to year-1.(Change from baseline to year-1 of Cth for each brain region mentioned above.)
- Change in the mean kurtosis (MK), an index of tissue complexity, as measured by MRI diffusion kurtosis (DKI) sequence sequence, in multiple brain regions (mentioned in outcome #5), baseline to year-1.(Change from baseline to year-1 of MK for each brain region mentioned above.)
- Change in the Intracellular volume (ICV), as measured by MRI NODDI sequence, in multiple brain regions, baseline to year-1.(Change from baseline to year-1 of ICV for each brain region mentioned above.)
- Change in fractional anisotropy (FA), as measured by diffusion tensor imaging (DTI) sequence, in multiple brain regions (mentioned in outcome #5), baseline to year-1.(Change from baseline to year-1 of FA for each brain region mentioned above.)
研究者
Edwin George, MD, PhD
Associate Professor of Neurology
Wayne State University