Detection of Phosphorylated Alpha-Synuclein in Colonic Tissue Biopsy During Routine Colonoscopy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Detection of phosphorylated alpha-synuclein in colon tissue samples
研究概览
简要总结
The goal of this observational study is to learn whether tissue samples taken from the colon during routine colonoscopy can detect signs of Parkinson's disease or REM Sleep Behavior Disorder (RBD). The main question it aims to answer is:
Can doctors find a protein called alpha-synuclein in colon tissue samples from people with Parkinson's disease and RBD?
Currently, Parkinson's disease is diagnosed by observing symptoms like tremors and movement problems and RBD by loss of muscle atonia during REM sleep, but by then the disease has already progressed significantly. Earlier detection could help doctors start treatment sooner.
详细描述
What is this study about? This study is testing whether doctors can detect signs of Parkinson's disease or REM Sleep Behavior Disorder (RBD) by taking small tissue samples from the colon during a routine colonoscopy. Researchers want to see if they can find a specific protein called alpha-synuclein that builds up in people with Parkinson's disease or RBD.
Why is this study important? Currently, Parkinson's disease is diagnosed mainly by observing symptoms like tremors and movement problems and RBD is characterized by the loss of muscle atonia during REM sleep. However, by the time these symptoms appear, the disease has already progressed significantly. Finding a way to detect the disease earlier could help doctors start treatment sooner and potentially slow down the disease.
Who can participate?
Adults between 40-99 years old People who have already been diagnosed with Parkinson's disease or REM Sleep Behavior Disorder People who are already scheduled to have a routine colonoscopy for colon cancer screening or other medical reasons What happens during the study?
**During the colonoscopy:**
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Relatively healthy men and women ≥40-99 years of age
- •Patients with a diagnosis of
- •Clinically confirmed PD or
- •Clinically confirmed RBD with no diagnosis of PD, DLB or MSA
- •Patients must have agreed to undergo a routine colonoscopy as part of their screening or surveillance for colon cancer or for diagnostic purposes for the exclusion of other GI diseases
排除标准
- •Use of anticoagulants (Plavix or aspirin alone is allowed)
- •Under active treatment for colon cancer; 30-day post anti-cancer treatment allowed
- •Current, ongoing gastrointestinal illness
- •Recent intrabdominal surgery
- •Pregnant or planning to become pregnant before the scheduled colonoscopy
- •Significant cognitive impairment, as determined by study investigators
研究组 & 干预措施
Parkinson's Disease (PD)
Trial participants with Parkinson's disease
REM Sleep Behavior Disorder (RBD)
Trial participants with REM Sleep Behavior Disorder (RBD)
结局指标
主要结局
Detection of phosphorylated alpha-synuclein in colon tissue samples
时间窗: At time of colonoscopy procedure
次要结局
未报告次要终点