Multicenter, Randomized, Double-blinded, Placebo-controlled Clinical Trial of Donepezil for the Treatment of Mild Cognitive Impairment in Parkinson's Disease
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- Parkinson's Disease-Cognitive Rating Scale (PD-CRS)
研究概览
简要总结
Phase II, multi-centric, randomized, double-blinded, placebo-controlled, parallel design clinical trial to evaluate the safety, tolerability and efficacy of Donepezil in patients with Mild Cognitive Impairment in Parkinson's Disease (PD-MCI). A total of 120 patients with PD-MCI will be randomized to 12 months of oral Donepezil 10mg or matching placebo (1:1).
Primary and co-primary efficacy endpoints are cognitive and functional cognitive scales: PD-CRS and PD-CFRS. Secondary efficacy endpoints include: cognitive tests evaluating attention, executive functions, language, memory and visuospatial domain; mood, anxiety, and apathy scales; questionnaires to evaluate quality of life; and subjective impression scales. Serum Neurofilament light chain, genetic screening of GBA, ApoE and MAPT, and Magnetic Resonance Imaging will be performed in a subset of these patients.
The study will be conducted in 20 different centers around Spain. The Movement Disorders Unit of the Neurology Department at Sant Pau Hospital (Barcelona, Spain) will be the coordinating center.
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 50-80
- •PD diagnosis according to MDS criteria
- •Hoehn and Yahr stage I-III
- •Persistent subjective cognitive complaints for at least 6 months
- •MDS PD-MCI Level I and Level II criteria
- •Persistent PD-MCI for at least 3 months
- •Stable dopaminergic treatment for at least 1 month
排除标准
- •PD dementia criteria
- •Severe motor complications
- •DBS or any brain condition that may be contributing to cognitive impairment
- •Active psychosis, major hallucinations, HADS ≥11, active impulse control disorder, or other active severe behavioral disorders.
- •Treatment under anticholinergics, cholinergic enhancers, or neuroleptics.
- •History of symptomatic arterial hypotension.
- •Hypersensitivity or intolerance to donepezil or any of the excipients
- •Pregnancy
- •Unstable medical or surgical condition
- •Any other significant observation that, in the investigator's opinion, would contraindicate participation in the study.
研究组 & 干预措施
Donepezil
干预措施: Donepezil Hydrochloride (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Parkinson's Disease-Cognitive Rating Scale (PD-CRS)
时间窗: 12 months
Global cognition
Parkinson's Disease-Cognitive Functional Rating Scale (PD-CFRS)
时间窗: 12 months
Cognitive functional performance
次要结局
- Hospital Anxiety and Depression Scale(12 months)
- Starkstein Apathy scale(12 months)
- TMT-B(12 months)
- Rey-Osterrieth complex figure test (ROCF)(12 months)
- Clinical Global Impressions-Severity of illness(12 months)
- Trail Making Test A (TMT-A)(12 months)
- Boston Naming Test(12 months)
- Free and cued selective reminding test(12 months)
- CGI-Global improvement(12 months)
- Judgment of Line Orientation(12 months)
- recall of ROCF(12 months)
- Phonemic Fluency(12 months)
- direct Digit Span(12 months)
- Schwab & England scale(12 months)
- Neuropsychiatric Inventory(12 months)
- Patient Global Impression of Change(12 months)
- 8-item Parkinson's Disease Questionnaire(12 months)
- Category fluency(12 months)