Evaluation of the Efficacy of Rasagiline in Apathy in Drug-naïve Patients With Parkinson's Disease by a Multi-center Study
Evaluation of the Efficacy of Rasagiline in Apathy in Drug-naïve Patients With Parkinson's Disease by a Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Study.
Among the psychiatric symptoms observed in the premotor phase of Parkinson's disease (PD) and/or in "de novo" patients, apathy is relatively frequent (estimated to 23%). However, the neuropathological bases of apathy are still unknown. However, recent data suggests that apathy could be linked to a more specific dopaminergic denervation in the ventral striatum.
Rasagiline increases the bioavailability of striatal endogenous dopamine by blocking the MAO-B. Some recent data suggest rasagiline could be effective to improve apathy in Parkinson's disease.
The primary outcome is to demonstrate a significant reduction of apathy using the Lille apathy rating scale (LARS) in drug naive patients with early diagnosed Parkinson's disease, using a treatment by rasagiline.
研究概览
详细说明
Study design :
Randomized, double-blind, rasagiline (1 mg) vs placebo study. Parallel group (randomization 1/1). Duration 3 months 16 recruiting centers in France
Population :
50 drug-naïve patients with Parkinson's disease, with apathy. 2 groups : 25 patients with placebo and 25 patients with rasagiline.
3 visits
- Visit 1 : inclusion / randomisation/ first study medication dispensation
- Visit 2 (1.5 month after V1) : first evaluation and second study medication dispensation.
- Visit 3 (3 months after V1, final visit) : second evaluation
研究类型
注册 (预期的)
阶段
- 第四阶段
联系人和位置
学习地点
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Clermont-Ferrand、法国、63003
- CHU clermont-ferrand
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Drug-naïve patients with Parkinson's disease (UKPDBB criteria)
- No dementia (Mattis dementia rating scale > 130; Mini Mental Sate Examination ≥26)
- No depression (MADRS < 15)
- Criteria of apathy from Robert et al (2009)
- At least mild apathy (≥-21 to Lille Apathy Rating Scale)
- Age : 35-70 y
- Affiliation to social security
- Agreement of patients
Exclusion Criteria:
- - Any antiparkinsonian treatment (L.dopa, dopamine agonists, MAO-B-I, amantadine, anticholinergics). Patients treated by dopamine agonists but who have stopped it more than 3 months before their inclusion can be included.
- Ongoing severe psychiatric or somatic diseases
- Others treatments :
- antipsychotics
- antidepressants and anxiolytics (exclusion if the treatment is not stable the month before inclusion)
- psychostimulants (methylphenidate, adrafinil, modafinil, deanol, vitamin C, sulbutiamine, glutamic acid, aspartic acid)
- any contra-indication according to SmPC
- patients under guardianship
- Women without efficient contraception
- Person who participate to an other study
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：rasagiline
Randomized, double-blind, rasagiline (1 mg) vs placebo study.
Parallel group (randomization 1/1).
Duration 3 months 16 recruiting centers in France
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安慰剂比较：placebo
Randomized, double-blind, rasagiline (1 mg) vs placebo study.
Parallel group (randomization 1/1).
Duration 3 months 16 recruiting centers in France
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Lille Apathy Rating Scale (LARS) score
大体时间：at the visit 3 (after 3 months of treatment)
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at the visit 3 (after 3 months of treatment)
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次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Motor assessment : Unified Parkinson's Disease Rating Scale
大体时间：at the visit 3 (after 3 months of treatment)
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at the visit 3 (after 3 months of treatment)
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Depressive and anxiety symptoms : MADRS + Hamilton anxiety scale
大体时间：at the visit 3 (after 3 months of treatment)
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at the visit 3 (after 3 months of treatment)
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Self assessment of apathy : Starkstein
大体时间：at the visit 3 (after 3 months of treatment)
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at the visit 3 (after 3 months of treatment)
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Quality of life : PDQ 39
大体时间：at the visit 3 (after 3 months of treatment)
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at the visit 3 (after 3 months of treatment)
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Cognitive assessment: MATTIS dementia rating scale, MMSE, executive functions battery
大体时间：at the visit 3 (after 3 months of treatment)
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at the visit 3 (after 3 months of treatment)
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Hyperdopaminergic symptoms : Parkinson's disease behavioral scale
大体时间：at the visit 3 (after 3 months of treatment)
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at the visit 3 (after 3 months of treatment)
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Fatigue assessment : Parkinson Fatigue Scale
大体时间：at the visit 3 (after 3 months of treatment)
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at the visit 3 (after 3 months of treatment)
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合作者和调查者
合作者
调查人员
- 首席研究员：Denis PEZET、University Hospital, Clermont-Ferrand
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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