D-serine Adjuvant Treatment for Parkinson's Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- UPDRS scores
研究概览
简要总结
The proposed experiment will evaluate the effects of the NMDA receptor full agonist D-serine (~2g/day) on persistent symptoms of Parkinson's Disease and on antiparkinsonian drugs-induced dyskinesias.
D-serine will be used as add-on therapy to on-going medications received by Parkinson's Disease patients. The rational for this study stems from observations made in pervious clinical trials with schizophrenia patients, in which it was demonstrated that D-serine adjuvant treatment resulted in:1)improvement of parkinsonian side effects induced by antipsychotic drugs and 2) improvement of depression and negative (i.e apathy, blunted effects, anhedonia) symptoms which are similar to symptoms encountered in Parkinson's Disease.
The study will have a crossover design in accordance to which each patient will receive, in random order D-serine and placebo for a 6 weeks period each. Thus, any participant will have the opportunity to receive the experimental treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PD diagnosis
- •≥2 on UPDRS items 32,33
- •receive treatment with L-dopa alone or in combination with other antiparkinsonian medications.
排除标准
- •current or previous history of other neurological disorders
- •unstable medical conditions
- •renal pathology
- •pregnant female patients excluded
研究组 & 干预措施
1
干预措施: D-serine (~2g/day) (Drug)
2
干预措施: D-serine (~2g/day) (Drug)
结局指标
主要结局
UPDRS scores
时间窗: 6 weeks
PANSS scores
时间窗: 6 weeks
次要结局
未报告次要终点
研究者
Heresco-Levi Uriel
Princepal Investigator
Herzog Hospital