Citalopram as a Posterior Cortical Protective Therapy in Parkinson Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Change in visuospatial cortex PiB distribution volume ratio (DVR)
研究概览
简要总结
This Parkinson disease (PD) trial will test whether 26 months of citalopram, compared to placebo, can alter the build-up of toxic amyloid-beta plaques in the visuospatial cortex of the brain linked to visuospatial cognitive impairment in PD.
详细描述
This study is a proof-of-concept Parkinson disease trial aimed at delaying visuospatial cognitive decline, an important component of Parkinson dementia. In Parkinson disease, low-range cortical Abeta plaque levels associate with serotonin terminal losses. Multicenter Parkinson disease observational findings show that selective serotonin reuptake inhibitors (SSRIs) associate with lower dementia conversion risk and different cerebrospinal fluid Abeta-42 levels. This study aims to test the hypothesis that citalopram use in Parkinson disease will reduce visuospatial cortex Abeta plaque accrual, leading to an amelioration of longitudinal visuospatial cognitive decline linked to Parkinsonian dementia. The study will test this hypothesis in a randomized placebo-controlled trial of citalopram 20mg daily over 26 months in Parkinson disease subjects (age ≥65) without depression (n=58).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with a Parkinson Disease (PD) diagnosis based on the United Kingdom Parkinson's Disease Society Brain Bank Research Center clinical diagnostic criteria
- •Modified Hoehn and Yahr (HY) scores spanning 2.0 to 3.0
- •Age 65 years or greater
排除标准
- •Diagnosis of an atypical parkinsonian condition
- •Participants on neuroleptics and participants with a history of use of anti-depressants (including selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), bupropion, St. John's Wort or other serotoninergic agents in the year preceding study enrollment
- •Evidence of a large artery stroke or mass lesion on brain imaging
- •Participants with a life threatening comorbid illness
- •Severe claustrophobia precluding PET imaging
- •Inability to participate in research procedures involving ionizing radiation
- •Pregnancy or breastfeeding
- •Participants with active depression as defined by a Geriatric Depression Scale score of >10 or on the basis of clinical diagnosis by the PI
- •Participants who report active suicidal ideation as defined by an affirmative answer to questions 1 and 2 on the C-SSRS
- •Participants with baseline HY scores <2.0 or ≥3.0
- •Participants with a QTc interval on baseline EKG >0.45 for men or >0.47 for women
- •Subjects taking certain contraindicated medications at baseline
- •Subjects unable to swallow pills
- •Subjects with a previous history of mania, ongoing hepatic impairment or epilepsy
- •Subjects with a known allergy to citalopram or escitalopram
- •Subjects with substantial cognitive impairment or dementia that would prevent them from providing informed consent
- •Subjects in another ongoing clinical trial
- •Subjects with treatment-naieve Parkinson disease
研究组 & 干预措施
Citalopram
20mg daily
干预措施: Citalopram 20mg (Drug)
Placebo
matching placebo pills
干预措施: Placebo (Drug)
结局指标
主要结局
Change in visuospatial cortex PiB distribution volume ratio (DVR)
时间窗: Baseline to month 26
PiB PET can assess the density of amyloid-beta plaques in the brain. This imaging method will be used to quantify the amount of change in amyloid-beta plaques levels--measured specifically within the visuospatial cortex--between month 0 and month 26.
次要结局
- Change in Benton Judgement of Line Orientation (JOLO) test score(Baseline to month 26)
- Change in Montreal Cognitive Assessment (MoCA) score(Baseline to month 26)
研究者
Vikas Kotagal
Associate Professor of Neurology
University of Michigan