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.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Lille Apathy Rating Scale (LARS) score
研究概览
简要总结
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.
详细描述
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
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •- 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
研究组 & 干预措施
rasagiline
Randomized, double-blind, rasagiline (1 mg) vs placebo study. Parallel group (randomization 1/1). Duration 3 months 16 recruiting centers in France
干预措施: AZILECT® (Drug)
placebo
Randomized, double-blind, rasagiline (1 mg) vs placebo study. Parallel group (randomization 1/1). Duration 3 months 16 recruiting centers in France
干预措施: Placebo (Drug)
结局指标
主要结局
Lille Apathy Rating Scale (LARS) score
时间窗: at the visit 3 (after 3 months of treatment)
次要结局
- Motor assessment : Unified Parkinson's Disease Rating Scale(at the visit 3 (after 3 months of treatment))
- Depressive and anxiety symptoms : MADRS + Hamilton anxiety scale(at the visit 3 (after 3 months of treatment))
- Fatigue assessment : Parkinson Fatigue Scale(at the visit 3 (after 3 months of treatment))
- Self assessment of apathy : Starkstein(at the visit 3 (after 3 months of treatment))
- Quality of life : PDQ 39(at the visit 3 (after 3 months of treatment))
- Cognitive assessment: MATTIS dementia rating scale, MMSE, executive functions battery(at the visit 3 (after 3 months of treatment))
- Hyperdopaminergic symptoms : Parkinson's disease behavioral scale(at the visit 3 (after 3 months of treatment))